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1.  Persistent pain in a community-based sample of children and adolescents: Sex differences in psychological constructs 
The prevalence of persistent and recurrent pain among children and adolescents has important economic, social and psychological repercussions. The impact of chronic pain in children extends beyond the affected individuals – more than one-third of parents of children with pain report clinically significant levels of stress and depression. Although many pain-related psychological factors have been examined in chronic pediatric pain populations, much of that research involved clinical samples. Community-based research, however, is necessary to uncover the way pain is experienced by youth, regardless of whether treatment is sought or is available. This study aimed to ascertain the lifetime prevalence of pediatric pain in a Canadian community-based sample, and to explore age and sex differences in children who report persistent pain and those who do not with respect to several constructs believed to play important roles in the development and maintenance of persistent pain.
BACKGROUND:
Very few studies have investigated the psychological factors associated with the pain experiences of children and adolescents in community samples.
OBJECTIVES:
To examine the lifetime prevalence of, and psychological variables associated with, persistent pain in a community sample of children and adolescents, and to explore differences according to sex, age and pain history.
METHODS:
Participants completed the Childhood Anxiety Sensitivity Index (CASI), the Child Pain Anxiety Symptoms Scale (CPASS), the Multidimensional Anxiety Scale for Children-10 (MASC-10), the Pain Catastrophizing Scale for Children (PCS-C) and a pain history questionnaire that assessed chronicity and pain frequency. After research ethics board approval, informed consent/assent was obtained from 1022 individuals recruited to participate in a study conducted at the Ontario Science Centre (Toronto, Ontario).
RESULTS:
Of the 1006 participants (54% female, mean [± SD] age 11.6±2.7 years) who provided complete data, 27% reported having experienced pain that lasted for three months or longer. A 2×2×2 (pain history, age and sex) multivariate ANOVA was conducted, with the total scores on the CASI, the CPASS, the MASC-10 and the PCS-C as dependent variables. Girls with a history of persistent pain expressed higher levels of anxiety sensitivity (P<0.001) and pain catastrophizing (P<0.001) than both girls without a pain history and boys regardless of pain history. This same pattern of results was found for anxiety and pain anxiety in the older, but not the younger, age group.
CONCLUSIONS:
Boys and girls appear to differ in terms of how age and pain history relate to the expression of pain-related psychological variables. Given the prevalence of persistent pain found in the study, more research is needed regarding the developmental implications of persistent pain in childhood and adolescence.
PMCID: PMC3206778  PMID: 22059200
Children; Persistent pain; Psychosocial factors; Sex differences
2.  Pain Site Frequency and Location in Sickle Cell Disease: the PiSCES Project 
Pain  2009;145(1-2):246-251.
Treatment options for sickle cell disease (SCD) pain could be tailored to pain locations. But few epidemiologic descriptions of SCD pain location exist; these are based on few subjects over short time periods. We examined whether SCD pain locations vary by disease genotype, gender, age, frequency of pain, depression, pain crisis or healthcare utilization.
We enrolled 308 adults with SCD in 2002–2004. Subjects kept daily pain diaries for up to 6 months, including a body chart. Analyses employed mixed model and generalized estimating equations.
260 subjects completed at least one body chart. An average of 3.3/16 sites (25%) were painful. The number of pain sites varied by age, depression, frequent pain days, crisis and unplanned hospital/ED utilization. Lower back, knee/shin and hip, hurt on average more than a third of pain days, while jaw and pelvis hurt on fewer than 10% of days. Odds of a crisis were increased substantially when pain was in the arm, shoulder, upper back, sternum, clavicle, chest or pelvis (OR>1.5) while the odds of unplanned utilization were substantially increased for the sternum, clavicle and chest (OR>2.0).
Pain in SCD varies considerably both within and between subjects, although it occurs most commonly in the lower back and lower extremities. The number and location of pain sites varies significantly by age, frequent pain, crisis and utilization. Identification and understanding of combinations of pain location and intensity may help to understand the etiology of SCD and improve SCD management.
doi:10.1016/j.pain.2009.06.029
PMCID: PMC2771372  PMID: 19631468
3.  Comparing Diary and Retrospective Reports of Pain and Activity Restriction in Children and Adolescents with Chronic Pain Conditions 
The Clinical journal of pain  2009;25(4):299-306.
Objective
The current study investigated the daily relationship between pain, activity restriction and depression in children and adolescents with chronic pain, and compared participants’ responses on diary and retrospective assessment measures.
Method
Data collection included the administration of diary and retrospective measures of pain, activity restriction, and depression to 93 children with recurrent headache, juvenile chronic arthritis, and sickle cell disease. The study used HLM to examine the relationship between daily pain and activity restriction, and analyses compared participants’ responses on diary and retrospective assessment measures.
Results
Using diary measures, daily pain intensity was related to children’s levels of activity restriction. Diary completion was predicted by age and diary-type, with younger children and children utilizing electronic diaries demonstrating higher compliance. Pain intensity was significantly higher on retrospective compared to diary measures, demonstrating inflation in retrospective reports of pain. No significant differences between measures of activity restriction emerged.
Discussion
These preliminary results suggest that while retrospective reports of activity restriction may be an acceptable alternative to daily diary assessment for children with chronic pain, retrospective measures of pain intensity may show inflated pain levels. To provide support for the findings, longitudinal research comparing responses to diary versus retrospective measures is recommended.
doi:10.1097/AJP.0b013e3181965578
PMCID: PMC2709738  PMID: 19590478
chronic pain; activity restriction; depression; children; adolescents
4.  Characteristics of Pain and Stooling in Children with Recurrent Abdominal Pain 
Objective
To collect symptom data longitudinally from children with recurrent abdominal pain (RAP) and Control (asymptomatic) children.
Methods
Children with RAP (n = 77) and Controls (n = 33) ages 7–10 yrs. completed daily diaries for two weeks tracking pain frequency and severity, how often the pain interfered with activities, and stooling pattern.
Results
RAP children reported a greater number of pain episodes and greater pain severity than Control children. Pain commonly was reported to be in the periumbilical area and occurred evenly across the day in both groups. However, the pain interfered with activity more often in the RAP group. There was a positive relation between pain and interference with activities. Both groups reported stool changes but there were no differences between groups in stool character (e.g., hard, mushy, etc.). For both groups the presence of watery stool was related positively to pain. Of children with RAP, 65% could be categorized as having irritable bowel syndrome (IBS) whereas 35% were classifiable as having functional abdominal pain (FAP) according to the pediatric Rome II criteria.
Conclusions
To our knowledge this is the first longitudinal report of symptoms in children with RAP compared with Controls. These data demonstrate that there is considerable overlap between children with RAP and Control children on a number of items commonly obtained in the history (e.g., pain location, timing, and stooling pattern). A majority of children with RAP could be characterized as having IBS. The relationship between pain reports and interference with activities substantiates the need to deal specifically with the abdominal pain to decrease disability. The relationship between pain and watery stools requires further study.
doi:10.1097/01.mpg.0000243437.39710.c0
PMCID: PMC2826272  PMID: 17255832
Recurrent abdominal pain; diary; pain; stool pattern; irritable bowel syndrome; functional abdominal pain
5.  A record review of reported musculoskeletal pain in an Ontario long term care facility 
BMC Geriatrics  2006;6:5.
Background
Musculoskeletal (MSK) pain is one of the leading causes of chronic health problems in people over 65 years of age. Studies suggest that a high prevalence of older adults suffer from MSK pain (65% to 80%) and back pain (36% to 40%). The objectives of this study were:
1. To investigate the period prevalence of MSK pain and associated subgroups in residents of a long-term care (LTC) facility.
2. To describe clinical features associated with back pain in this population.
3. To identify associations between variables such as age, gender, cognitive status, ambulatory status, analgesic use, osteoporosis and osteoarthritis with back pain in a long-term care facility.
Methods
A retrospective chart review was conducted using a purposive sampling approach of residents' clinical charts from a LTC home in Toronto, Canada. All medical records for LTC residents from January 2003 until March 2005 were eligible for review. However, facility admissions of less than 6 months were excluded from the study to allow for an adequate time period for patient medical assessments and pain reporting/charting to have been completed. Clinical data was abstracted on a standardized form. Variables were chosen based on the literature and their suggested association with back pain and analyzed via multivariate logistic regression.
Results
140 (56%) charts were selected and reviewed. Sixty-nine percent of the selected residents were female with an average age of 83.7 years (51–101). Residents in the sample had a period pain prevalence of 64% (n = 89) with a 40% prevalence (n = 55) of MSK pain. Of those with a charted report of pain, 6% (n = 5) had head pain, 2% (n = 2) neck pain, 21% (n = 19) back pain, 33% (n = 29) extremity pain and 38% (n = 34) had non-descriptive/unidentified pain complaint. A multivariate logistic regression analysis revealed that osteoporosis was the only significant association with back pain from the variables studied (P = 0.001).
Conclusion
Residents with back pain represent 13.6% (n = 19) of the sample population studied. This is as frequent as other serious conditions commonly found in LTC. Of the variables studied, only osteoporosis and the self-report of back pain were found to be associated. The back pain resident in this facility can typically be described as female, osteoporotic, with mild to moderate dementia, an independent or assisted walker having low levels of depression. Further research using other sites is needed to determine the overall prevalence of this condition and its impact on quality of life issues. The results of this study should inform future research in this area.
doi:10.1186/1471-2318-6-5
PMCID: PMC1435899  PMID: 16556306
6.  A Novel Tool for the Assessment of Pain: Validation in Low Back Pain 
PLoS Medicine  2009;6(4):e1000047.
Joachim Scholz and colleagues develop and validate an assessment tool that distinguishes between radicular and axial low back pain.
Background
Adequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.
Methods and Findings
Using a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%–97%) and specificity (97%; 95% CI 89%–100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.
Conclusions
We present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.
Editors' Summary
Background
Pain, although unpleasant, is essential for survival. Whenever the body is damaged, nerve cells detecting the injury send an electrical message via the spinal cord to the brain and, as a result, action is taken to prevent further damage. Usually pain is short-lived, but sometimes it continues for weeks, months, or years. Long-lasting (chronic) pain can be caused by an ongoing, often inflammatory condition (for example, arthritis) or by damage to the nervous system itself—experts call this “neuropathic” pain. Damage to the brain or spinal cord causes central neuropathic pain; damage to the nerves that convey information from distant parts of the body to the spinal cord causes peripheral neuropathic pain. One example of peripheral neuropathic pain is “radicular” low back pain (also called sciatica). This is pain that radiates from the back into the legs. By contrast, axial back pain (the most common type of low back pain) is confined to the lower back and is non-neuropathic.
Why Was This Study Done?
Chronic pain is very common—nearly 10% of American adults have frequent back pain, for example—and there are many treatments for it, including rest, regulated exercise (physical therapy), pain-killing drugs (analgesics), and surgery. However, the best treatment for any individual depends on the exact nature of their pain, so it is important to assess their pain carefully before starting treatment. This is usually done by scoring overall pain intensity, but this assessment does not reflect the characteristics of the pain (for example, whether it occurs spontaneously or in response to external stimuli) or the complex biological processes involved in pain generation. An assessment designed to take such factors into account might improve treatment outcomes and could be useful in the development of new therapies. In this study, the researchers develop and test a new, standardized tool for the assessment of chronic pain that, by examining many symptoms and signs, aims to distinguish between pain subtypes.
What Did the Researchers Do and Find?
One hundred thirty patients with several types of peripheral neuropathic pain and 57 patients with non-neuropathic (axial) low back pain completed a structured interview of 16 questions and a standardized bedside examination of 23 tests. Patients were asked, for example, to choose words that described their pain from a list provided by the researchers and to grade the intensity of particular aspects of their pain from zero (no pain) to ten (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration—chronic pain often alters responses to harmless stimuli. Using “hierarchical cluster analysis,” the researchers identified six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain based on the patterns of symptoms and signs revealed by the interviews and physical tests. They then used “classification tree analysis” to identify the six questions and ten physical tests that discriminated best between pain subtypes and combined these items into a tool for a Standardized Evaluation of Pain (StEP). Finally, the researchers asked whether StEP, which took 10–15 minutes, could identify patients with radicular back pain and discriminate them from those with axial back pain in an independent group of 137 patients with chronic low back pain. StEP, they report, accurately diagnosed these two conditions and was well accepted by the patients.
What Do These Findings Mean?
These findings indicate that a standardized assessment of pain-related signs and symptoms can provide a simple, quick diagnostic procedure that distinguishes between radicular (neuropathic) and axial (non-neuropathic) low back pain. This distinction is crucial because these types of back pain are best treated in different ways. In addition, the findings suggest that it might be possible to identify additional pain subtypes using StEP. Because these subtypes may represent conditions in which different pain mechanisms are acting, classifying patients in this way might eventually enable physicians to tailor treatments for chronic pain to the specific needs of individual patients rather than, as at present, largely guessing which of the available treatments is likely to work best.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000047.
This study is further discussed in a PLoS Medicine Perspective by Giorgio Cruccu and and Andrea Truini
The US National Institute of Neurological Disorders and Stroke provides a primer on pain in English and Spanish
In its 2006 report on the health status of the US, the National Center for Health Statistics provides a special feature on the epidemiology of pain, including back pain
The Pain Treatment Topics Web site is a resource, sponsored partly by associations and manufacturers, that provides information on all aspects of pain and its treatment for health care professionals and their patients
Medline Plus provides a brief description of pain and of back pain and links to further information on both topics (in English and Spanish)
The MedlinePlus Medical Encyclopedia also has a page on low back pain (in English and Spanish)
doi:10.1371/journal.pmed.1000047
PMCID: PMC2661253  PMID: 19360087
7.  Pain in hospitalized children: A prospective cross-sectional survey of pain prevalence, intensity, assessment and management in a Canadian pediatric teaching hospital 
BACKGROUND:
Pain is under-recognised and undertreated. Although standards now exist for pain management, it is not known if this has improved care of hospitalized children.
OBJECTIVES:
To benchmark pain prevalence, pain intensity, pain assessment documentation and pharmacological treatment of pain. The aim was to highlight areas of good practice, identify areas for improvement and inform development of hospital standards, education, future audits and the research agenda.
METHODS:
The present prospective cross-sectional survey of all medical and surgical inpatient units took place on a single day at the Hospital for Sick Children (Toronto, Ontario), a Canadian tertiary and quaternary pediatric hospital. A structured, verbally administered questionnaire was used to obtain information on patient demographics, pain before admission, pain intensity during admission and pain treatment. Charts were reviewed to establish frequency of documented pain assessment, the pain assessment tool used and analgesics given. Subgroup analysis was included for age, sex, visible minority or fluency in English, medical versus surgical services and acute pain service input.
RESULTS AND CONCLUSIONS:
Two hundred forty-one (83%) of the 290 inpatients or their carergivers were interviewed. It was found that 27% of patients usually had pain before admission, and 77% experienced pain during admission. Of these, 23% had moderate or severe pain at interview and 64% had moderate or severe pain sometime in the previous 24 h. Analgesics were largely intermittent and single-agent, although 90% of patients found these helpful. Fifty-eight per cent of those with pain received analgesics in the preceding 24 h but only 25% received regular analgesia. Only 27% of children had any pain score documented in the preceding 24 h. It was concluded that pain was infrequently assessed, yet occurred commonly across all age groups and services and was often moderate or severe. Although effective, analgesic therapy was largely single-agent and intermittent. Widespread dissemination of results to all professional groups has resulted in the development of a continuous quality assurance program for pain at the Hospital for Sick Children. A re-audit is planned to evaluate changes resulting from the new comprehensive pain strategies.
PMCID: PMC2670807  PMID: 18301813
Inpatient pain; Pain assessment; Pain intensity; Pain management; Pain prevalence; Pediatric pain
8.  Inter and intra-rater repeatability of the scoring of foot pain drawings 
Background
Foot pain drawings (manikins) are commonly used to describe foot pain location in self-report health surveys. Respondents shade the manikin where they experience pain. The manikin is then scored via a transparent overlay that divides the drawings into areas. In large population based studies they are often scored by multiple raters. A difference in how different raters score manikins (inter-rater repeatability), or in how an individual rater scores manikins over time (intra-rater repeatability) can therefore affect data quality. This study aimed to assess inter- and intra-rater repeatability of scoring of the foot manikin.
Methods
A random sample was generated of 50 respondents to a large population based survey of adults aged 50 years and older who experienced foot pain and completed a foot manikin. Manikins were initially scored by any one of six administrative staff (Rating 1). These manikins were re-scored by a second rater (Rating 2). The second rater then re-scored the manikins one week later (Rating 3). The following scores were compared: Rating 1 versus Rating 2 (inter-rater repeatability), and Rating 2 versus Rating 3 (intra-rater repeatability). A novel set of clinically relevant foot pain regions made up of one or more individual areas on the foot manikin were developed, and assessed for inter- and intra-rater repeatability.
Results
Scoring agreement of 100% (all 50 manikins) was seen in 69% (40 out of 58) of individual areas for inter-rater scoring (range 94 to 100%), and 81% (47 out of 58) of areas for intra-rater scoring (range 96 to 100%). All areas had a kappa value of ≥0.70 for inter- and intra-rater scoring. Scoring agreement of 100% was seen in 50% (10 out of 20) of pain regions for inter-rater scoring (range 96 to 100%), and 95% (19 out of 20) of regions for intra-rater scoring (range 98 to 100%). All regions had a kappa value of >0.70 for inter- and intra-rater scoring.
Conclusions
Individual and multiple raters can reliably score the foot pain manikin. In addition, our proposed regions may be used to reliably classify different patterns of foot pain using the foot manikin.
doi:10.1186/1757-1146-6-44
PMCID: PMC3831824  PMID: 24180324
Foot pain; Pain drawings; Manikins; Reliability; Repeatability; Agreement
9.  COOP-WONCA charts: a suitable functional status screening instrument in acute low back pain? 
BACKGROUND: Functional status is considered an important measure of health status in primary care. The COOP-WONCA charts, which comprise six single-item scales, have mainly been used to determine functional ability in chronically ill patients. AIM: A study was carried out to determine whether the charts are able to measure the degree of functional impairment associated with acute illness and the improvement in functional ability accompanying the process of recovery. METHOD: A total of 95 patients presenting with acute low back pain were recruited from 15 single-handed general practices in northern Germany. At presentation and at two-week follow up, these patients completed self-administered questionnaires which included the COOP-WONCA charts. The charts ask patients to use the timescale of the past two weeks when rating their condition. Baseline and follow-up measurements of the charts were compared and correlations of chart scores with patients' measurements of pain intensity on a visual analogue scale, general practitioners' ratings of impairment and patients' measurements of recovery were analysed. RESULTS: Only the chart measuring change in health revealed a deterioration in functional ability associated with the onset of pain and an improvement in functional status at follow up. Two of the other charts indicated a deterioration at follow up. Only the chart measuring change in health was correlated with ratings of pain and impairment at baseline. At follow up, strong correlations were found between general practitioners' assessments of impairment, patients' ratings of pain and patients' ratings of recovery for all scales except for those measuring social activities and daily activities. The patients interpreted the instructions for using the COOP-WONCA charts differently; some included the period of acute back pain while others did not. CONCLUSION: Of the six charts only the change in health chart proved to be a suitable scale for measuring short-term changes in functional ability among general practice patients with acute low back pain. This may partly be a result of patients misunderstanding the instructions. If the COOP-WONCA charts are used with acutely ill patients, the fixed two-weeks timescale is not appropriate. It is suggested that patients consider their present complaints when rating their condition.
PMCID: PMC1239469  PMID: 8745864
10.  Sociodemographic factors in a pediatric chronic pain clinic: The roles of age, sex and minority status in pain and health characteristics 
Journal of pain management  2010;3(3):273-281.
Little is known about how sociodemographic factors relate to children’s chronic pain. This paper describes the pain, health, and sociodemographic characteristics of a cohort of children presenting to an urban tertiary chronic pain clinic and documents the role of age, sex and minority status on pain-related characteristics. A multidisciplinary, tertiary clinic specializing in pediatric chronic pain. Two hundred and nineteen patients and their parents were given questionnaire packets to fill out prior to their intake appointment which included demographic information, clinical information, Child Health Questionnaire – Parent Report, Functional Disability Index – Parent Report, Child Somatization Index – Parent Report, and a Pain Intensity Scale. Additional clinical information was obtained from patients’ medical records via chart review. This clinical sample exhibited compromised functioning in a number of domains, including school attendance, bodily pain, and health compared to normative data. Patients also exhibited high levels of functional disability. Minority children evidenced decreased sleep, increased somatization, higher levels of functional disability, and increased pain intensity compared to Caucasians. Caucasians were more likely to endorse headaches than minorities, and girls were more likely than boys to present with fibromyalgia. Younger children reported better functioning than did teens. The results indicate that sociodemographic factors are significantly associated with several pain-related characteristics in children with chronic pain. Further research must address potential mechanisms of these relationships and applications for treatment.
PMCID: PMC3113686  PMID: 21686073
Chronic pain; pediatric; clinical cohort; ethnic differences
11.  18D. Yoga Promotes Relaxation in Children and Adolescents With Recurrent Headache 
Focus Areas: Integrative Approaches to Care, Supporting Behavioral Change, Alleviating Pain
Objective:
Recurrent headaches are prevalent in children and adolescents. Up to 89% of these individuals identify stress as a trigger. Yoga offers a complementary and alternative method for this population who often lacks effective relaxation tools for stress relief. This presentation describes the yoga group offered as part of the Integrative Headache Clinic (IHC) at Children's Hospital Colorado. One of the objectives is to determine the effect of the yoga group for children and adolescents with recurrent headaches on pain and relaxation scores.
Description:
Over the course of 18 months (January 2011 to June 2012), a retrospective chart review was conducted of 40 children and adolescents with an average age of 15 years, 62.5% of whom were female. During the first hour of clinic, every individual takes part in a 50-minute group yoga session consisting of 10 asanas that promote relaxation and pain relief. Before and after yoga group, participants rate their level of pain and relaxation on a scale from 0 to 10 (with 0 being no pain or relaxation and 10 being maximum pain or relaxation). The average “before yoga” pain score was 3.7 ( /- 3.0) and “after yoga” pain score was 3.4 ( /-3.1) (P=.0672), representing a decrease in pain. The average “before yoga” relaxation score was 5.2 ( /- 2.3) and “after yoga” relaxation score was 7.5 ( /-1.9) (P<.0001), representing a statistically significant increase in relaxation.
Results:
Group yoga is effective in promoting relaxation in children and adolescents with recurrent headache. Yoga may offer an adjunct to common pharmaceutical options for headache management for children and adolescents.
doi:10.7453/gahmj.2013.097CP.S18D
PMCID: PMC3875043
12.  Pain as a Comorbidity of Pediatric Obesity 
The purpose of this study was to document the prevalence and characteristics of physical pain in a sample of severely obese children and adolescents. In this retrospective chart review, primary measures included current and past pain, pain intensity, and pain characteristics during a 5-minute walk test. Pain assessments for 74 patients (mean age 11.7 years; 53% female; 41% African American) were conducted by a physical therapist. Past pain was reported by 73% of the sample, with 47% reporting pain on the day of program enrollment. Although average pain intensity was moderate (M = 5.5/10), alarmingly, 42% of those with current pain reported severe pain (6/10 to 10/10). Overall, pain occurred primarily in the lower extremities and with physical activity. Patients reporting current pain had a significantly higher body mass index than those reporting no pain. These findings suggest that pain is common in severely obese youth, and furthermore, that pain should be recognized as a comorbidity of pediatric obesity. Routinely screening severely obese children and adolescents for pain presence and intensity is recommended.
doi:10.1177/1941406412458315
PMCID: PMC3979543  PMID: 24723992
obesity; pain; pediatric population; body mass index
13.  How Well Do Clinical Pain Assessment Tools Reflect Pain in Infants? 
PLoS Medicine  2008;5(6):e129.
Background
Pain in infancy is poorly understood, and medical staff often have difficulty assessing whether an infant is in pain. Current pain assessment tools rely on behavioural and physiological measures, such as change in facial expression, which may not accurately reflect pain experience. Our ability to measure cortical pain responses in young infants gives us the first opportunity to evaluate pain assessment tools with respect to the sensory input and establish whether the resultant pain scores reflect cortical pain processing.
Methods and Findings
Cortical haemodynamic activity was measured in infants, aged 25–43 wk postmenstrual, using near-infrared spectroscopy following a clinically required heel lance and compared to the magnitude of the premature infant pain profile (PIPP) score in the same infant to the same stimulus (n = 12, 33 test occasions). Overall, there was good correlation between the PIPP score and the level of cortical activity (regression coefficient = 0.72, 95% confidence interval [CI] limits 0.32–1.11, p = 0.001; correlation coefficient = 0.57). Of the different PIPP components, facial expression correlated best with cortical activity (regression coefficient = 1.26, 95% CI limits 0.84–1.67, p < 0.0001; correlation coefficient = 0.74) (n = 12, 33 test occasions). Cortical pain responses were still recorded in some infants who did not display a change in facial expression.
Conclusions
While painful stimulation generally evokes parallel cortical and behavioural responses in infants, pain may be processed at the cortical level without producing detectable behavioural changes. As a result, an infant with a low pain score based on behavioural assessment tools alone may not be pain free.
Rebeccah Slater and colleagues show that although painful stimulation generally evokes parallel cortical and behavioral responses in infants, pain may produce cortical responses without detectable behavioral changes.
Editors' Summary
Background.
Pain is a sensory and emotional experience. It is normally triggered by messages transmitted from specialized receptors (nociceptors) in the body to integrative centers in the spinal cord and brainstem and on to the brain, where it undergoes higher sensory and cognitive analysis, allowing the body to respond appropriately to the stimuli. While the experience of pain may be considered to be unpleasant, it is a useful tool in communicating to us and to others that there is something wrong with our bodies. Ultimately, these responses help restrict further damage to the body and start the process of healing.
In a clinical setting, the ability to communicate about pain allows an individual to seek strategies to ease the pain, such as taking analgesics. Being unable to effectively communicate one's experience of pain leaves the individual vulnerable to prolonged suffering. One such vulnerable group is infants.
Ignored and untreated pain in infants has been shown to have immediate and long-term effects as a result of structural and physiological changes within the nervous system. For example, the body responds to untreated pain by increased release of stress hormones, which may be associated with increased morbidity and mortality in the short term. Long-term effects of pain may include altered pain perception, chronic pain syndromes, and somatic complaints such as sleep disturbances, feeding problems, and inability to self-regulate in response to internal and external stressors. It has been proposed that attention deficit disorders, learning disorders, and behavioral problems in later childhood may be linked to repetitive pain in the preterm infant.
Why Was This Study Done?
Until as recently as the 1990s, newborns in some clinical centres underwent surgery with minimal anesthesia. Also, newborns received little or no pain management postoperatively or for painful procedures such as lumbar punctures or circumcisions. Since then, there has been growing awareness amongst clinicians that pain may be experienced from the earliest stages of postnatal life and that inadequate analgesia may lead to the type of long-term consequences mentioned above. However, gauging how much pain infants and young children are experiencing remains a substantial challenge. The researchers in this study wanted to assess the association between cortical pain responses in young infants and currently used tools for the assessment of pain in these infants. These current tools are based on behavioral and physiological measures, such as change in facial expression, and it is possible that these tools do not give an adequate measure of pain especially in infants born preterm.
What Did the Researchers Do and Find?
Twelve clinically stable infants were studied on 33 occasions when they required a heel lance to obtain a blood sample for a clinical reason. The researchers examined the relationship between brain activity and a clinical pain score, calculated using the premature infant pain profile (PIPP) in response to a painful event. Activity in the somatosensory cortex was measured noninvasively by near-infrared spectroscopy, which measures brain regional changes in oxygenated and deoxygenated hemoglobin concentration. The PIPP is a well-established pain score that ascribes a value to infant behavior such as change in facial expression.
They found that changes in brain activity in response to a painful stimulus were related to the PIPP scores. These changes were more strongly linked to the behavioral components of the PIPP, e.g., facial expression, than physiological components, e.g., heart rate. They also found that a positive brain response could occur in the absence of any facial expression.
What Do These Findings Mean?
Behaviors to communicate pain require motor responses to sensory and emotional stimuli. The maturity of this complex system in infants is not clearly understood. The results of this study raise further awareness of the ability of infants to experience pain and highlight the possibility that pain assessment based on behavioral tools alone may underestimate the pain response in infants.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050129.
Important papers on pain in human neonates are discussed in the open access Paediatric Pain Letter with links to original articles
The Institute of Child Health in London has a Web site describing a three-year international project on improving the assessment of pain in hospitalized children, with many useful links
The International Association for the Study of Pain (IASP) provides accurate and up-to-date information and links about pain mechanisms and treatment
doi:10.1371/journal.pmed.0050129
PMCID: PMC2504041  PMID: 18578562
14.  Spine day 2012: spinal pain in Swiss school children– epidemiology and risk factors 
BMC Pediatrics  2013;13:159.
Background
The key to a better understanding of the immense problem of spinal pain seems to be to investigate its development in adolescents. Based on the data of Spine Day 2012 (an annual action day where Swiss school children were examined by chiropractors on a voluntary basis for back problems), the aim of the present study was to gain systematic epidemiologic data on adolescent spinal pain in Switzerland and to explore risk factors per gender and per spinal area.
Method
Data (questionnaires and physical examinations) of 836 school children were descriptively analyzed for prevalence, recurrence and severity of spinal pain. Of those, 434 data sets were included in risk factor analysis. Using logistic regression analysis, psycho-social parameters (presence of parental back pain, parental smoking, media consumption, type of school bag) and physical parameters (trunk symmetry, posture, mobility, coordination, BMI) were analyzed per gender and per spinal area.
Results
Prevalence of spinal pain was higher for female gender in all areas apart from the neck. With age, a steep increase in prevalence was observed for low back pain (LBP) and for multiple pain sites. The increasing impact of spinal pain on quality of life with age was reflected in an increase in recurrence, but not in severity of spinal pain. Besides age and gender, parental back pain (Odds ratio (OR)=3.26, p=0.011) and trunk asymmetry (OR=3.36, p=0.027) emerged as risk factors for spinal pain in girls. Parental smoking seemed to increase the risk for both genders (boys: OR=2.39, p=0.020; girls: OR=2.19, p=0.051). Risk factor analysis per spinal area resulted in trunk asymmetry as risk factor for LBP (OR=3.15, p=0.015), while parental smoking increased the risk for thoracic spinal pain (TSP) (OR=2.83, p=0.036) and neck pain (OR=2.23, p=0.038). The risk for TSP was further enhanced by a higher BMI (OR=1.15, p=0.027).
Conclusion
This study supports the view of adolescent spinal pain as a bio-psycho-social problem that should be investigated per spinal area, age and gender. The role of trunk asymmetry and passive smoking as risk factors as well as the association between BMI and TSP should be further investigated, preferably in prospective studies.
doi:10.1186/1471-2431-13-159
PMCID: PMC3852258  PMID: 24094041
Adolescence; Risk factor; Spinal pain
15.  An Experimental Paradigm for the Prediction of Post-Operative Pain (PPOP) 
Many women undergo cesarean delivery without problems, however some experience significant pain after cesarean section. Pain is associated with negative short-term and long-term effects on the mother. Prior to women undergoing surgery, can we predict who is at risk for developing significant postoperative pain and potentially prevent or minimize its negative consequences? These are the fundamental questions that a team from the University of Washington, Stanford University, the Catholic University in Brussels, Belgium, Santa Joana Women's Hospital in São Paulo, Brazil, and Rambam Medical Center in Israel is currently evaluating in an international research collaboration. The ultimate goal of this project is to provide optimal pain relief during and after cesarean section by offering individualized anesthetic care to women who appear to be more 'susceptible' to pain after surgery.
A significant number of women experience moderate or severe acute post-partum pain after vaginal and cesarean deliveries. 1 Furthermore, 10-15% of women suffer chronic persistent pain after cesarean section. 2 With constant increase in cesarean rates in the US 3 and the already high rate in Brazil, this is bound to create a significant public health problem. When questioning women's fears and expectations from cesarean section, pain during and after it is their greatest concern. 4 Individual variability in severity of pain after vaginal or operative delivery is influenced by multiple factors including sensitivity to pain, psychological factors, age, and genetics. The unique birth experience leads to unpredictable requirements for analgesics, from 'none at all' to 'very high' doses of pain medication. Pain after cesarean section is an excellent model to study post-operative pain because it is performed on otherwise young and healthy women. Therefore, it is recommended to attenuate the pain during the acute phase because this may lead to chronic pain disorders. The impact of developing persistent pain is immense, since it may impair not only the ability of women to care for their child in the immediate postpartum period, but also their own well being for a long period of time.
In a series of projects, an international research network is currently investigating the effect of pregnancy on pain modulation and ways to predict who will suffer acute severe pain and potentially chronic pain, by using simple pain tests and questionnaires in combination with genetic analysis. A relatively recent approach to investigate pain modulation is via the psychophysical measure of Diffuse Noxious Inhibitory Control (DNIC). This pain-modulating process is the neurophysiological basis for the well-known phenomenon of 'pain inhibits pain' from remote areas of the body. The DNIC paradigm has evolved recently into a clinical tool and simple test and has been shown to be a predictor of post-operative pain.5 Since pregnancy is associated with decreased pain sensitivity and/or enhanced processes of pain modulation, using tests that investigate pain modulation should provide a better understanding of the pathways involved with pregnancy-induced analgesia and may help predict pain outcomes during labor and delivery. For those women delivering by cesarean section, a DNIC test performed prior to surgery along with psychosocial questionnaires and genetic tests should enable one to identify women prone to suffer severe post-cesarean pain and persistent pain. These clinical tests should allow anesthesiologists to offer not only personalized medicine to women with the promise to improve well-being and satisfaction, but also a reduction in the overall cost of perioperative and long term care due to pain and suffering. On a larger scale, these tests that explore pain modulation may become bedside screening tests to predict the development of pain disorders following surgery.
doi:10.3791/1671
PMCID: PMC2818706  PMID: 20107427
16.  A Systematic Review of Sleep in Pediatric Pain Populations 
Objective
The primary aim of this systematic review was to examine the evidence for a pain-sleep relationship in children with persistent pain by reviewing studies using single and mixed pediatric persistent pain samples.
Method
Electronic searches of Medline, PubMed, the Cochrane Database of Systematic Reviews, and PsycINFO were conducted to identify all relevant empirical studies. Studies were included in the review if the majority of participants were between 0-17 years and from one of the following pediatric pain populations: juvenile idiopathic arthritis, sickle cell disease, migraine/headache, functional abdominal pain, juvenile fibromyalgia syndrome, chronic musculoskeletal pain, or mixed populations including the aforementioned conditions.
Results
Research from single and mixed sample studies support the hypothesis that children and adolescents with persistent pain suffer from sleep impairment. Literature addressing factors that may influence or mediate the pain-sleep relationship and the functional outcomes of the pain-sleep relationship was reviewed, and a model of the interrelationships with pain and sleep developed.
Conclusion
Findings from this review highlight the need to assess and treat sleep problems in children presenting with persistent pain. Healthcare providers should consider conducting routine sleep screenings, including a comprehensive description of sleep patterns and behaviors obtained through clinical interview, sleep diaries, and/or the use of standardized measures of sleep. Future research focusing on investigating the mechanisms associating sleep and pediatric persistent pain and on functional outcomes of poor sleep in pediatric pain populations is needed.
doi:10.1097/DBP.0b013e31827d5848
PMCID: PMC3562475  PMID: 23369958
adolescent; child; persistent pain; sleep
17.  Effect of varying the time frame for COOP-WONCA functional health status charts: a nested randomised controlled trial in Bristol, UK 
STUDY OBJECTIVES: To investigate whether changing the stated time frame for COOP-WONCA charts has any effect on responses. Specifically, to assess the effect of attempting to avoid the situation where the time frame crosses the onset of an acute episode. DESIGN: A randomised controlled trial of two time frames, nested within a main trial comparing early discharge with a hospital at home scheme against routine discharge policy. The time frames compared were the standard two weeks (four for the pain chart) and a shorter period of 48 hours for all seven charts. SETTING: Acute hospital wards in Frenchay Healthcare Trust and the Avon Orthopaedic Centre in Bristol. PARTICIPANTS: Patients entered into the main trial, who were medically stable, in need of continued rehabilitative care but suitable for discharge to hospital at home. MAIN RESULTS: A total of 200 patients were randomised, 106 to the shorter time frame, 94 to the standard charts. No clear differences were observed between the two groups for the proportion failing to self complete the charts. For the (seven) chart scores, only pain was statistically significantly different between the time frames (Mann-Whitney p = 0.0085; proportion reporting moderate or severe pain 19% higher in the standard group, 95% confidence intervals 5% to 33%). For both this chart and that for change in health, however, there was evidence of greater differences between the versions of the chart among those admitted more recently (p values for relevant interactions 0.004 and < or = 0.001 respectively). CONCLUSIONS: While the present findings give some support for the wide applicability of the standard version, there is sufficient evidence here to indicate that the time frame may influence the results, particularly for patients with a recent acute episode. In the absence of further data, then, it would seem prudent to consider a shorter time frame for such patients, especially if the aim is to assess current health status or to measure changes over a comparatively short period of time, or both.
 
PMCID: PMC1756607  PMID: 9604043
18.  Balloon Kyphoplasty 
Executive Summary
Objective
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
Conclusion
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
19.  Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States 
Journal of Pain Research  2013;6:459-469.
Background
Neuropathic pain (NeP) can be chronic, debilitating, and can interfere with sleep, functioning, and emotional well being. While there are multiple causes of NeP, few studies have examined the disease burden and treatment patterns associated with post-traumatic/post-surgical (PTPS) NeP.
Objective
To characterize pain, health status, function, health care resource utilization, lost productivity, and costs among subjects with PTPS NeP in the United States.
Methods
This observational study enrolled 100 PTPS NeP subjects recruited during routine visits from general practitioner and specialist sites. Subjects completed a one-time questionnaire with validated measures of pain severity and pain interference, health status, sleep, anxiety and depression, productivity, and study-specific items on demographics, employment status, and out-of-pocket expenses. Investigators completed a case report form based on a 6-month retrospective chart review, recording subjects’ clinical characteristics as well as current and previous medications/treatments for NeP. Subjects were stratified into mild, moderate, and severe pain groups.
Results
Subjects’ demographic characteristics were: mean age of 54.9 years, 53% female, and 22% employed for pay. Mean pain severity score was 5.6 (0–10 scale), with 48% and 35% classified as having moderate and severe pain, respectively. The mean number of comorbidities increased with greater pain severity (P = 0.0009). Patient-reported outcomes were worse among PTPS NeP subjects with more severe pain, including pain interference with function, health state utility, sleep, and depression (P < 0.0001). Eighty-two percent of subjects were prescribed two or more NeP medications. The total mean annualized adjusted direct and indirect costs per subject were $11,846 and $29,617, respectively. Across pain severity levels, differences in annualized adjusted direct and indirect costs were significant (P < 0.0001).
Conclusion
PTPS NeP subjects reported high pain scores, which were associated with poor health utility, sleep, mood, and function, as well as high health care resource utilization and costs. The quality of life impact and costs attributable to PTPS NeP suggest an unmet need for effective and comprehensive management.
doi:10.2147/JPR.S44939
PMCID: PMC3698142  PMID: 23825931
trauma/surgery; neuropathic pain; quality-of-life; patient-reported outcomes; costs; productivity
20.  Risk factors for development of non-specific musculoskeletal pain in preteens and early adolescents: a prospective 1-year follow-up study 
Background
Musculoskeletal pain symptoms are common in children and adolescents. These symptoms have a negative impact on children's physical and emotional well-being, but their underlying aetiology and risk factors are still poorly understood. Most of the previous cohort studies were conducted among mid and/or late adolescents and were mainly focused on a specific pain location (e.g. low back pain or neck pain). The purpose of this study is to estimate occurrence of new-onset pain symptoms, in all musculoskeletal locations, in preteens and early adolescents and investigate risk factors for development of these symptoms.
Methods
1756 schoolchildren (mean age 10.8) were recruited from schools in southern Finland. Information was extracted as to whether they experienced musculoskeletal pain and a total of 1192 children were identified as free of musculoskeletal pain symptoms. Information was collected on factors which could potentially predict the development of musculoskeletal pain: headache, abdominal pain, sadness/feeling down, day-time tiredness, difficulty in falling asleep, waking up during nights, level of physical activity and hypermobility. These children were followed-up 1-year later and those with new episodes of non-traumatic and traumatic musculoskeletal pain symptoms were identified.
Results
A total of 1113 schoolchildren (93% of baseline pain-free children) were found at one-year follow-up. New episodes of musculoskeletal pain were reported by 21.5% of these children. Of them 19.4% reported non-traumatic pain and 4.0% reported traumatic pain. The neck was the most commonly reported site with non-traumatic pain, while the lower limb was the most common site for traumatic pain. The independent risk factors for non-traumatic musculoskeletal pain were headache (OR = 1.68, [95% CI 1.16–2.44]) and day-time tiredness (OR = 1.53, [95% CI 1.03–2.26]). The risk factors for traumatic musculoskeletal pain were vigorous exercise (OR = 3.40 [95% CI 1.39–8.31]) and day-time tiredness (OR = 2.97 [95% CI 1.41–6.26]).
Conclusion
This study highlights that there may be two types of pain entities with both distinct and common aspects of aetiology. For primary prevention purposes, school healthcare professionals should pay attention to preteens and early adolescents practicing vigorous exercise (predictor of traumatic pain), reporting headache (predictor of non-traumatic pain) and reporting day-time tiredness (predictor of both types of pain).
doi:10.1186/1471-2474-8-46
PMCID: PMC1891107  PMID: 17521435
21.  Orthopedic Complications of Overweight in Children and Adolescents 
Pediatrics  2006;117(6):2167-2174.
OBJECTIVE
Few studies have quantified the prevalence of weight-related orthopedic conditions in otherwise healthy overweight children. The goal of the present investigation was to describe the musculoskeletal consequences of pediatric overweight in a large pediatric cohort of children that included severely overweight children.
METHODS
Medical charts from 227 overweight and 128 nonoverweight children and adolescents who were enrolled in pediatric clinical studies at the National Institutes of Health from 1996 to 2004 were reviewed to record pertinent orthopedic medical history and musculoskeletal complaints. Questionnaire data from 183 enrollees (146 overweight) documented difficulties with mobility. In 250, lower extremity alignment was determined by bilateral metaphyseal-diaphyseal and anatomic tibiofemoral angle measurements made from whole-body dual-energy x-ray absorptiometry scans.
RESULTS
Compared with nonoverweight children, overweight children reported a greater prevalence of fractures and musculoskeletal discomfort. The most common self-reported joint complaint among those who were questioned directly was knee pain (21.4% overweight vs 16.7% nonoverweight). Overweight children reported greater impairment in mobility than did nonoverweight children (mobility score: 17.0 ± 6.8 vs 11.6 ± 2.8). Both metaphyseal-diaphyseal and anatomic tibiofemoral angle measurements showed greater malalignment in overweight compared with nonoverweight children.
CONCLUSIONS
Reported fractures, musculoskeletal discomfort, impaired mobility, and lower extremity malalignment are more prevalent in overweight than nonoverweight children and adolescents. Because they affect the likelihood that children will engage in physical activity, orthopedic difficulties may be part of the cycle that perpetuates the accumulation of excess weight in children.
doi:10.1542/peds.2005-1832
PMCID: PMC1863007  PMID: 16740861
obesity; fractures; valgus deformity; child; quality of life
22.  Pain-QuILT: Clinical Feasibility of a Web-Based Visual Pain Assessment Tool in Adults With Chronic Pain 
Background
Chronic pain is a prevalent and debilitating problem. Accurate and timely pain assessment is critical to pain management. In particular, pain needs to be consistently tracked over time in order to gauge the effectiveness of different treatments. In current clinical practice, paper-based questionnaires are the norm for pain assessment. However, these methods are not conducive to capturing or tracking the complex sensations of chronic pain. Pain-QuILT (previously called the Iconic Pain Assessment Tool) is a Web-based tool for the visual self-report and tracking of pain (quality, intensity, location, tracker) in the form of time-stamped records. It has been iteratively developed and evaluated in adolescents and adults with chronic pain, including usability testing and content validation. Clinical feasibility is an important stepping-stone toward widespread implementation of a new tool. Our group has demonstrated Pain-QuILT clinical feasibility in the context of a pediatric chronic pain clinic. We sought to extend these findings by evaluating Pain-QuILT clinical feasibility from the perspective of adults with chronic pain, in comparison with standard paper-based methods (McGill Pain Questionnaire [MPQ] and Brief Pain Inventory [BPI]).
Objective
The goal of our study was to assess Pain-QuILT for (1) ease of use, (2) time for completion, (3) patient preferences, and (4) to explore the patterns of self-reported pain across the Pain-QuILT, MPQ, and BPI.
Methods
Participants were recruited during a scheduled follow-up visit at a hospital-affiliated pain management and physical rehabilitation clinic in southwestern Ontario. Participants self-reported their current pain using the Pain-QuILT, MPQ, and BPI (randomized order). A semistructured interview format was used to capture participant preferences for pain self-report.
Results
The sample consisted of 50 adults (54% female, 27/50) with a mean age of 50 years. Pain-QuILT was rated as significantly easier to use than both the MPQ and BPI (P<.01) and was also associated with the fewest difficulties in completion. On average, the time to complete each tool was less than 5 minutes. A majority of participants (58%, 29/50) preferred Pain-QuILT for reporting their pain over alternate methods (16%, 8/50 for MPQ; 14%, 7/50 for BPI; 12%, 6/50 for “other”). The most commonly chosen pain descriptors on MPQ were matched with Pain-QuILT across 91% of categories. There was a moderate-to-high correlation between Pain-QuILT and BPI scores for pain intensity (r=.70, P<.01).
Conclusions
The results of this clinical feasibility study in adults with chronic pain are consistent with our previously published pediatric findings. Specifically, data indicate that Pain-QuILT is (1) easy to use, (2) quick to complete, (3) preferred by a majority of patients, and (4) correlated as expected with validated pain measures. As a digital, patient-friendly method of assessing and tracking pain, we conclude that Pain-QuILT has potential to add significant value as one standard component of chronic pain management.
doi:10.2196/jmir.3292
PMCID: PMC4034112  PMID: 24819478
chronic pain; assessment tool; Internet; clinical feasibility
23.  Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer 
Background
Pain is one of the most common and distressing symptoms reported by adolescents with cancer. Despite advancements in pain assessment and management research, pain due to cancer and/or its treatments continues to be poorly managed. Our research group has developed a native iPhone application (app) called Pain Squad to tackle the problem of poorly managed pain in the adolescent with cancer group. The app functions as an electronic pain diary and is unique in its ability to collect data on pain intensity, duration, location, and the impact pain has on an adolescent’s life (ie, relationships, school work, sleep, mood). It also evaluates medications and other physical and psychological pain management strategies used. Users are prompted twice daily at configurable times to complete 20 questions characterizing their pain and the app transmits results to a database for aggregate reporting through a Web interface. Each diary entry represents a pain case filed by an adolescent with cancer and a reward system (ie, moving up through law-enforcement team ranks, built-in videotaped acknowledgements from fictitious officers) encourages consistent use of the diary.
Objective
Our objective was to design, develop, and test the usability, feasibility, compliance, and satisfaction of a game-based smartphone pain assessment tool for adolescents with cancer.
Methods
We used both low- and high-fidelity qualitative usability testing with qualitative semi-structured, audio-taped interviews and iterative cycles to design and refine the iPhone based Pain Squad app. Qualitative thematic analysis of interviews using constant comparative methodology captured emergent themes related to app usability. Content validity was assessed using question importance-rating surveys completed by participants. Compliance and satisfaction data were collected following a 2-week feasibility trial where users were alarmed to record their pain twice daily on the app.
Results
Thematic analysis of usability interviews showed the app to be appealing overall to adolescents. Analyses of both low- and high-fidelity testing resulted in minor revisions to the app to refine the theme and improve its usability. Adolescents resoundingly endorsed the game-based nature of the app and its virtual reward system. The importance of app pain diary questions was established by content validity analysis. Compliance with the app, assessed during feasibility testing, was high (mean 81%, SD 22%) and adolescents from this phase of the study found the app likeable, easy to use, and not bothersome to complete.
Conclusions
A multifaceted usability approach demonstrated how the Pain Squad app could be made more appealing to children and adolescents with cancer. The game-based nature and built-in reward system of the app was appealing to adolescents and may have resulted in the high compliance rates and satisfaction ratings observed during clinical feasibility testing.
doi:10.2196/jmir.2350
PMCID: PMC3636147  PMID: 23475457
neoplasms; pain; child; adolescent; youth; cellular phone; game
24.  Psychological therapies for the management of chronic and recurrent pain in children and adolescents 
Background
Chronic pain affects many children, who report severe pain, distressed mood, and disability. Psychological therapies are emerging as effective interventions to treat children with chronic or recurrent pain. This update adds recently published randomised controlled trials (RCTs) to the review published in 2009.
Objectives
To assess the effectiveness of psychological therapies, principally cognitive behavioural therapy and behavioural therapy, for reducing pain, disability, and improving mood in children and adolescents with recurrent, episodic, or persistent pain. We also assessed the risk of bias and methodological quality of the included studies.
Search methods
Searches were undertaken of MEDLINE, EMBASE, and PsycLIT. We searched for RCTs in references of all identified studies, meta-analyses and reviews. Date of most recent search: March 2012.
Selection criteria
RCTs with at least 10 participants in each arm post-treatment comparing psychological therapies with active treatment were eligible for inclusion (waiting list or standard medical care) for children or adolescents with episodic, recurrent or persistent pain.
Data collection and analysis
All included studies were analysed and the quality of the studies recorded. All treatments were combined into one class: psychological treatments; headache and non-headache outcomes were separately analysed on three outcomes: pain, disability, and mood. Data were extracted at two time points; post-treatment (immediately or the earliest data available following end of treatment) and at follow-up (at least three months after the post-treatment assessment point, but not more than 12 months).
Main results
Eight studies were added in this update of the review, giving a total of 37 studies. The total number of participants completing treatments was 1938. Twenty-one studies addressed treatments for headache (including migraine); seven for abdominal pain; four included mixed pain conditions including headache pain, two for fibromyalgia, two for pain associated with sickle cell disease, and one for juvenile idiopathic arthritis. Analyses revealed five significant effects. Pain was found to improve for headache and non-headache groups at post-treatment, and for the headache group at follow-up. Mood significantly improved for the headache group at follow-up, although, this should be interpreted with caution as there were only two small studies entered into the analysis. Finally, disability significantly improved in the non-headache group at post-treatment. There were no other significant effects.
Authors’ conclusions
Psychological treatments are effective in reducing pain intensity for children and adolescents (<18 years) with headache and benefits from therapy appear to be maintained. Psychological treatments also improve pain and disability for children with non-headache pain. There is limited evidence available to estimate the effects of psychological therapies on mood for children and adolescents with headache and non-headache pain. There is also limited evidence to estimate the effects on disability in children with headache. These conclusions replicate and add to those of the previous review which found psychological therapies were effective in reducing pain intensity for children with headache and non-headache pain conditions, and these effects were maintained at follow-up.
doi:10.1002/14651858.CD003968.pub3
PMCID: PMC3715398  PMID: 23235601
*Pain Management; Abdominal Pain [therapy]; Chronic Disease; Cognitive Therapy; Fibromyalgia [therapy]; Headache [therapy]; Hemoglobin SC Disease [complications]; Mood Disorders [therapy]; Pain [psychology]; Psychotherapy [*methods]; Randomized Controlled Trials as Topic; Recurrence; Adolescent; Child; Humans
25.  Pain Symptoms and Stooling Patterns Do Not Drive Diagnostic Costs for Children With Functional Abdominal Pain and Irritable Bowel Syndrome in Primary or Tertiary Care 
Pediatrics  2009;123(3):758.
OBJECTIVE
The objectives of this study were to (1) compare the cost of medical evaluation for children with functional abdominal pain or irritable bowel syndrome brought to a pediatric gastroenterologist versus children who remained in the care of their pediatrician, (2) compare symptom characteristics for the children in primary versus tertiary care, and (3) examine if symptom characteristics predicted the cost of medical evaluation.
METHODS
Eighty-nine children aged 7 to 10 years with functional abdominal pain or irritable bowel syndrome seen by a gastroenterologist (n = 46) or seen only by a pediatrician (n = 43) completed daily pain and stool diaries for 2 weeks. Mothers provided retrospective reports of their children’s symptoms in the previous year. Cost of medical evaluation was calculated via chart review of diagnostic tests and application of prices as if the patients were self-pay.
RESULTS
Child-reported diary data reflected no significant group differences with respect to pain, interference with activities, or stool characteristics. In contrast, mothers of children evaluated by a gastroenterologist viewed their children as having higher maximum pain intensity in the previous year. Excluding endoscopy costs, cost of medical evaluation was fivefold higher for children evaluated by a gastroenterologist, with higher cost across blood work, stool studies, breath testing, and diagnostic imaging. Symptom characteristics did not predict cost of care for either group.
CONCLUSIONS
Despite the lack of difference in symptom characteristics between children in primary and tertiary care, a notable differential in cost of evaluation exists in accordance with level of care. Symptom characteristics do not seem to drive diagnostic evaluation in either primary or tertiary care. Given the lack of differences in child-reported symptoms and the maternal perspective that children evaluated by a gastroenterologist had more severe pain, we speculate that parent perception of child symptoms may be a primary factor in seeking tertiary care.
doi:10.1542/peds.2008-0227
PMCID: PMC2821591  PMID: 19254999
recurrent abdominal pain; chronic abdominal pain; functional abdominal pain; irritable bowel syndrome; gastrointestinal symptoms; cost of care

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