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1.  Swim therapy reduces mechanical allodynia and thermal hyperalgesia induced by chronic constriction nerve injury in rats 
Pain medicine (Malden, Mass.)  2013;14(4):516-525.
Objective
Neuropathic pain is common and often difficult to treat because it generally does not respond well to the currently available pain medications or nerve blocks. Recent studies in both humans and animals have suggested that exercise may induce a transient analgesia and reduce acute pain in normal healthy individuals. We examined whether swim therapy could alleviate neuropathic pain in rats.
Design
Rats were trained to swim over a two week period in warm water. After the rats were trained, neuropathic pain was induced by constricting the right sciatic nerve and regular swimming was resumed. The sensitivity of each hind paw was monitored using the Hargreaves test and von Frey test to evaluate the withdrawal response thresholds to heat and touch.
Results
The paw ipsilateral to the nerve ligation expressed pain-like behaviors including thermal hyperalgesia and mechanical allodynia. Regular swim therapy sessions significantly reduced the mechanical allodynia and thermal hyperalgesia. Swim therapy had little effect on the withdrawal thresholds for the contralateral paw. In addition, swim therapy alone did not alter the thermal or mechanical thresholds of normal rats.
Conclusions
The results suggest that regular exercise, including swim therapy, may be an effective treatment for neuropathic pain caused by nerve injuries. This study, showing that swim therapy reduces neuropathic pain behavior in rats, provides a scientific rationale for clinicians to test the efficacy of exercise in the management of neuropathic pain. It may prove to be a safe and cost-effective therapy in a variety of neuropathic pain states.
doi:10.1111/pme.12057
PMCID: PMC3625453  PMID: 23438327
Exercise; Neuralgia; Pain Management; Rehabilitation Medicine
2.  Vasovagal Rates in Flouroscopically Guided Interventional Procedures: A Study of Over 8,000 Injections 
Pain medicine (Malden, Mass.)  2013;14(12):10.1111/pme.12241.
Objective
To determine the rate of vasovagal (vv) complications in fluoroscopically guided interventional procedures.
Design
Retrospective case series analysis of prospectively collected data from March 8, 2004 to January 30, 2009.
Setting
A single academic medical center.
Subjects
Four thousand one hundred eighty-three subjects undergoing 8,010 consecutive injections.
Outcome Measures
Pearson's chi-square test was used to determine the relationship between categorical variables.
Results
A total of 8,010 injections, including epidural steroid injections, radiofrequency nerve ablations, medial branch blocks, hip injections, knee injections, and glenohumeral injections were performed. Overall vv reaction rate was 2.6%, with 0.8% of procedures resulting in early terminated due to vv reaction. Peripheral joint injections had a vv rate of 0.2%, all occurring in hip injections. Transforaminal epidural steroid injections had a vv rate of 3.5%. Diagnostic blocks of the medial branches had the highest rate of vv (5.1%). Other predictors of vv reactions were identified including preprocedure pain score visual analog scale <5 (P = 0.004), male gender (P < 0.001), and age less than 65 years old (P < 0.001).
Conclusions
vv reactions have an overall low occurrence rate (2.6%) in interventional procedures ranging from 0% in peripheral knee and shoulder injections to 5.1% in medial branch blocks. Conservative treatment of vv reaction and willingness to terminate procedures resulted in no serious adverse events related to vv reaction in 8,010 procedures.
doi:10.1111/pme.12241
PMCID: PMC3887554  PMID: 24118835
Interventional; Fluoroscopy; Zygoapophyseal Joint; Sacroiliac Joint; Physician Performance; Medial Branch; Facet Joint
3.  Construct and Criterion-Based Validity of Brief Pain Coping Scales in Persons with Chronic Knee Osteoarthritis Pain 
Pain medicine (Malden, Mass.)  2012;14(2):265-275.
Objectives
A recent trend in clinical practice is to adopt short screening and diagnostic self-report instruments for patients with chronic pain. Brief 2-item pain coping and beliefs measures have recently been developed and have potential to improve decision making in clinical practice. Our study examined the construct and criterion-based validity of the 2-item per scale version of the Coping Strategies Questionnaire (CSQ).
Design
We used data obtained on a community-based sample of 873 persons with chronic knee osteoarthritis pain from the Osteoarthritis Initiative, a large longitudinal cohort study. Persons were administered the two-item per scale version of the CSQ. The International Classification of Functioning framework was used to select a variety of criterion-based measures for comparison to the CSQ. Spearman correlations and hierarchical regression models were used to characterize construct validity and Receiver Operating Characteristic Curves, sensitivity and specificity were used to describe criterion-based validity.
Results
Construct validity of the CSQ scales were generally supported, with the Catastrophizing and Praying or Hoping scales demonstrating the strongest construct validity across criterion measures. Criterion-based validity for the CSQ scales varied depending on the criterion measure. The Catastrophizing and Praying or Hoping scales also had the strongest criterion-based validity with ROC curve areas as high as 0.71 (95%CI= 0.67, 0.75), p<0.001 for identifying persons with substantial physical function deficits.
Conclusions
The findings suggest that several of the 2-item CSQ scales demonstrate a modest level of construct validity along with fair criterion-based validity. The Catastrophizing and Praying or Hoping scales appear to hold the most promise for clinical applications and future longitudinal research.
doi:10.1111/pme.12007
PMCID: PMC3594566  PMID: 23240934
Pain; Coping; Disability; Function
4.  Impact of Animal-Assisted Therapy for Outpatients with Fibromyalgia 
Pain medicine (Malden, Mass.)  2012;14(1):43-51.
Objectives
Animal-assisted therapy using dogs trained to be calm and provide comfort to strangers has been used as a complementary therapy for a range of medical conditions. This study was designed to evaluate the effects of brief therapy dog visits for fibromyalgia patients attending a tertiary outpatient pain management facility compared with time spent in a waiting room.
Design
Open-label with waiting room control
Setting
Tertiary care, university-based, outpatient pain management clinic
Subjects
A convenience sample of fibromyalgia patients was obtained through advertisements posted in the clinic.
Interventions
Participants were able to spend clinic waiting time with a certified therapy dog instead of waiting in the outpatient waiting area. When the therapy dog was not available, individuals remained in the waiting area.
Outcome measures
Self-reported pain, fatigue, and emotional distress were recorded using 11-point numeric rating scales before and after the therapy dog visit or waiting room time.
Results
Data were evaluated from 106 therapy dog visits and 49 waiting room controls, with no significant between-group demographic differences in participants. Average intervention duration was 12 minutes for the therapy dog visit and 17 minutes for the waiting room control. Significant improvements were reported for pain, mood, and other measures of distress among patients after the therapy dog visit but not the waiting room control. Clinically meaningful pain relief (≥2 points pain severity reduction) occurred in 34% after the therapy dog visit and 4% in the waiting room control. Outcome was not affected by the presence of comorbid anxiety or depression.
Conclusions
Brief therapy dog visits may provide a valuable complementary therapy for fibromyalgia outpatients.
doi:10.1111/j.1526-4637.2012.01522.x
PMCID: PMC3666031  PMID: 23170993
clinically meaningful pain relief; complementary therapy; mood; satisfaction; therapy dog; waiting room
5.  The Evolution and Practice of Acute Pain Medicine 
Pain medicine (Malden, Mass.)  2012;14(1):124-144.
Background
In recent years the field of acute pain medicine has witnessed a surge in its development, and pain has begun to be recognized not merely as a symptom, but as an actual disease process. This development warrants increased education of residents, both in the performance of regional anesthesia, as well as in the disease course of acute pain and the biopsychosocial mechanisms that define inter-individual variability.
Review Summary
We reviewed the organization and function of the modern acute pain medicine program. Following a discussion of the nomenclature of acute pain related practices, we discuss the historical evolution and modern role of acute pain medicine teams, including the use of traditional, as well as complementary and alternative, therapies for treating acute pain. Staffing and equipment requirements are also evaluated, in addition to the training requirements for achieving expertise in acute pain medicine. Lastly, we briefly explore future considerations related to the essential role and development of acute pain medicine.
Conclusion
The scope and practice of acute pain medicine must be expanded to include pre-pain/pre-intervention risk stratification and extended through the phase of subacute pain.
doi:10.1111/pme.12015
PMCID: PMC3547126  PMID: 23241132
acute pain medicine; anesthesiology; regional anesthesia; organization
6.  Intense focused ultrasound preferentially stimulates subcutaneous and focal neuropathic tissue: preliminary results 
Pain medicine (Malden, Mass.)  2012;14(1):84-92.
Objective
Potential peripheral sources of pain from subcutaneous tissue can require invasive evocative tests for their localization and assessment. Here we describe studies whose ultimate goal is development of a non-invasive evocative test for subcutaneous, painful tissue.
Design
We used a rat model of a focal and subcutaneous neuroma to test the hypothesis that intense focused ultrasound can differentiate focal and subcutaneous neuropathic tissue from control tissue. To do so we first applied intense focused ultrasound (2 MHz, with individual pulses of 0.1 seconds in duration) to the rat’s neuroma while the rat was under light anesthesia. We started with low values of intensity which we increased until intense focused ultrasound stimulation caused the rat to reliably flick its paw. We then applied that same intense focused ultrasound protocol to control tissue away from the neuroma and assayed for the rat’s response to that stimulation.
Results
Intense focused ultrasound of sufficient strength (I_sata of 600 +/− 160 W/cm^2) applied to the neuroma caused the rat to flick its paw, while the same intense focused ultrasound applied millimeters to a centimeter away failed to induce a paw flick.
Conclusion
Successful stimulation of the neuroma by intense focused ultrasound required co-localization of the neuroma and intense focused ultrasound, supporting our hypothesis.
doi:10.1111/j.1526-4637.2012.01510.x
PMCID: PMC3547133  PMID: 23137045
Intense Focused Ultrasound; neuropathic pain; localization; pain detection; neuroma
7.  The association of depression with pain-related treatment utilization in patients with multiple sclerosis 
Pain medicine (Malden, Mass.)  2012;13(12):1648-1657.
Objective
To better understand the association of depression with pain treatment utilization in an MS population.
Design
Cross-sectional survey.
Setting
Community-based survey.
Participants
Convenience sample of 117 individuals with MS.
Main Outcome Measures
Participants provided demographic information, descriptive information on utilization of pain treatments, pain intensity ratings on a 0–10 Numeric Rating Scale, and depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9).
Results
Participants reporting clinical levels of depressive symptoms (PHQ-9 ≥ 10) reported that they tried more pain treatments previously relative to participants with PHQ-9 < 10; however, the two groups did not differ in the number of treatments they were currently using. Additionally, participants with PHQ-9 ≥ 10 had more visits to providers for pain treatment relative to the group with PHQ-9 < 10. In subsequent analyses, results showed that these differences were no longer significant after controlling for level of pain intensity.
Conclusions
The results demonstrate that depression is not associated with higher pain treatment utilization. These findings support the assertion in previous studies that the mechanism by which depression impacts medical utilization is through increased appointments for nonspecific complaints, not for specific medical problems. While this suggests that treating depression may not be helpful in reducing pain treatment utilization specifically, it remains important to treat depression to reduce pain-related suffering and medical utilization more broadly.
doi:10.1111/j.1526-4637.2012.01513.x
PMCID: PMC3527650  PMID: 23137071
Pain; Depression; Medical Utilization; Multiple Sclerosis
8.  A FUNCTIONAL RELATIONSHIP BETWEEN TRIGEMINAL ASTROGLIAL ACTIVATION AND NR1 EXPRESSION IN A RAT MODEL OF TEMPOROMANDIBULAR JOINT INFLAMMATION 
Pain medicine (Malden, Mass.)  2012;13(12):1590-1600.
Objective
To examine the hypothesis that glial activation would regulate the expression of the NR1 subunit of the N-methyl-D-aspartate receptor in the trigeminal subnucleus caudalis (Sp5C) after temporomandibular joint (TMJ) inflammation.
Methods
Inflammation of temporomandibular joint (TMJ) was produced in rats by injecting 50μl complete Freund's adjuvant (CFA) into unilateral TMJ space. Sham control rats received incomplete Freund's adjuvant (IFA) injection. Mechanical nociception in the affected and non-affected TMJ site was tested by using a digital algometer. Fractalkine, fluorocitrate, and/or MK801 were intracisternally administrated to examine the relationship between astroglial activation and NR1 upregulation.
Results
CFA TMJ injection resulted in persistent ipsilateral mechanical hyperalgesia 1, 3 and 5 days after CFA injection. The inflammation also induced significant upregulation of CX3CR1 and GFAP beginning on day 1, and of NR1 beginning on day 3, within the ipsilateral Sp5C. Intracisternal administration of fluorocitrate for 5 days blocked the development of mechanical hyperalgesia as well as the upregulation of GFAP and NR1 in the Sp5C. Conversely, intracisternal injection of fractalkine for 5 days exacerbated the expression of NR1 in Sp5C and mechanical hyperalgesia induced by TMJ inflammation. Moreover, once daily intracisternal fractalkine administration for five days in naïve rats induced the upregulation of NR1 and mechanical hyperalgesia.
Conclusions
These results suggest that astroglial activation contributes to the mechanism of TMJ pain through the regulation of NR1 expression in Sp5C.
doi:10.1111/j.1526-4637.2012.01511.x
PMCID: PMC3527674  PMID: 23110394
Trigeminal pain; NMDA receptor; NR1; Astroglia; GFAP; Sp5C
9.  Sex differences in the stability of conditioned pain modulation (CPM) among patients with chronic pain 
Pain medicine (Malden, Mass.)  2013;14(11):10.1111/pme.12220.
Objectives
To examine the temporal stability of conditioned pain modulation (CPM), formerly termed diffuse noxious inhibitory controls (DNIC), among a sample of patients with chronic pain. The study also examined the factors that might be responsible for the stability of CPM.
Design & subjects, and methods
In this test-retest study, patients underwent a series of standardized psychophysical pain testing procedures designed to assess CPM on two separate occasions (i.e., baseline, follow-up). Patients also completed self-report measures of catastrophizing (PCS) and negative affect (NA).
Results
Overall, results provided evidence for the stability of CPM among patients with chronic pain. Results, however, revealed considerable sex differences in the stability of CPM. For women, results revealed a significant test-retest correlation between baseline and follow-up CPM scores. For men, however, the test-retest correlation between baseline and follow-up CPM scores was not significant. Results of a Fisher’s Z-test revealed that the stability of CPM was significantly greater for women than for men. Follow-up analyses revealed that the difference between men and women in the stability of CPM could not be accounted for by any demographic (e.g., age) and/or psychologic factors (PCS, NA).
Conclusions
Our findings suggest that CPM paradigms possess sufficient reliability to be incorporated into bedside clinical evaluation of patients with chronic pain, but only among women. The lack of CPM reproducibility/stability observed among men places limits on the potential use of CPM paradigms in clinical settings for the assessment of men’s endogenous pain-inhibitory function.
doi:10.1111/pme.12220
PMCID: PMC3833959  PMID: 23924369
Conditioned pain modulation; DNIC; catastrophizing; negative affect; chronic pain
10.  Under Treatment of Pain: A Prescription for Opioid Misuse Among the Elderly? 
Pain medicine (Malden, Mass.)  2013;14(11):10.1111/pme.12189.
Objective
To examine the demographic, physical, and mental health characteristics; current drug use patterns; motivations for use; and diversion sources among elderly prescription opioid misusers.
Design
Mixed methods design.
Setting
Research field offices, or senior or community center offices in South Florida.
Subjects
Individuals aged 60 and over reporting past 90-day prescription medication misuse; only prescription opioid misusers (N = 88) were included in the final analysis.
Methods
The Global Appraisal of Individual Needs was the main survey instrument. A subsample of elderly reporting substantial prescription drug misuse were chosen for the in-depth interview (N = 30).
Results
The mean age was 63.3. Fifty percent reported ever being admitted to a drug treatment program; several endorsed recent illicit drug use: powder cocaine and/or crack (35.2%), marijuana (30.7%), heroin (14.8%). The majority reported past year severe physical pain and discomfort (86.4%), and misuse of their primary opioid for pain (80.7%); over half (52.3%) obtained their primary opioid from their regular doctor. Qualitative data highlight the misuse of prescription opioids due to untreated or undertreated pain. Participants with primary opioid misuse for pain had over 12 times higher odds of obtaining the medication from their regular doctor (odds ratio [OR] = 12.22, P = 0.002) and had lower odds of using a dealer (OR = 0.20, P = 0.005).
Conclusions
Findings suggest that this group of elderly participants often misuse their own prescriptions for pain management. This study highlights the need to educate prescribing professionals on appropriate pain management for older adults while still being sensitive to issues of substance abuse and dependence.
doi:10.1111/pme.12189
PMCID: PMC3834188  PMID: 23841571
Older Adults; Pain Management; Substance Abuse; Opioids
11.  Chronic Pain Treatment and Health Service Utilization of Veterans with Hepatitis C Virus Infection 
Pain medicine (Malden, Mass.)  2012;13(11):1407-1416.
Objectives
Hepatitis C virus (HCV) infection is estimated to affect 2% of the general U.S. population and chronic pain is a common comorbidity among persons with HCV. The primary purpose of this study was to compare health service utilization of U.S. military veterans with HCV with and without the presence of comorbid chronic pain.
Design
Cross-sectional study with retrospective review of patient medical records.
Patients
One hundred seventy-one U.S. military veterans with confirmed HCV, recruited through a single U.S. Veterans Administration hospital.
Outcome Measures
Medical service utilization data from the past five years were extracted from participants’ electronic medical records.
Results
Sixty-four percent of veterans with HCV (n = 110) had chronic pain. Veterans with HCV and chronic pain utilized more health services including total inpatient stays (OR = 2.58 [1.46, 4.56]) and days hospitalized for psychiatric services (OR = 5.50 [3.37, 8.99]), compared to participants with HCV and no chronic pain, after statistically adjusting for demographic, psychiatric, substance use, medical comorbidity, and disability covariates. In addition, those with HCV and chronic pain had more total outpatient visits with primary care providers (OR = 1.73 [1.15, 2.59]), physical therapists (OR = 9.57 [4.79, 19.11]), and occupational therapists (OR = 2.72 [1.00, 7.48]).
Conclusions
Patients with HCV and chronic pain utilize medical services to a greater extent than patients with HCV but no chronic pain. Future studies that examine the efficacy of both pharmacological and nonpharmacological pain treatment for patients with comorbid HCV and chronic pain appear warranted.
doi:10.1111/j.1526-4637.2012.01476.x
PMCID: PMC3501572  PMID: 22958315
Hepatitis C; Chronic Pain; Veterans; Health Service Utilization
12.  Epigenetics and the Transition from Acute to Chronic Pain 
Pain medicine (Malden, Mass.)  2012;13(11):1474-1490.
Objective
To review the epigenetic modifications involved in the transition from acute to chronic pain and to identify potential targets for the development of novel, individualized pain therapeutics.
Background
Epigenetics is the study of heritable modifications in gene expression and phenotype that do not require a change in genetic sequence to manifest their effects. Environmental toxins, medications, diet, and psychological stresses can alter epigenetic processes such as DNA methylation, histone acetylation, and RNA interference. Since epigenetic modifications potentially play an important role in inflammatory cytokine metabolism, steroid responsiveness, and opioid sensitivity, they are likely key factors in the development of chronic pain. Although our knowledge of the human genetic code and disease-associated polymorphisms has grown significantly in the past decade, we have not yet been able to elucidate the mechanisms that lead to the development of persistent pain after nerve injury or surgery.
Design
Focused literature review
Results
Significant laboratory and clinical data support the notion that epigenetic modifications are affected by the environment and lead to differential gene expression. Similar to mechanisms involved in the development of cancer, neurodegenerative disease, and inflammatory disorders, the literature endorses an important potential role for epigenetics in chronic pain.
Conclusions
Epigenetic analysis may identify mechanisms critical to the development of chronic pain after injury, and may provide new pathways and target mechanisms for future drug development and individualized medicine.
doi:10.1111/j.1526-4637.2012.01488.x
PMCID: PMC3501579  PMID: 22978429
Epigenetics; Pain; DNA Methylation; Histone Deacetylase Inhibitors; RNA interference
13.  Aberrant drug-related behaviors: Unsystematic documentation does not identify prescription drug use disorder 
Pain medicine (Malden, Mass.)  2012;13(11):1436-1443.
Objective
No evidence-based methods exist to identify prescription drug use disorder (PDUD) in primary care (PC) patients prescribed controlled substances. Aberrant drug-related behaviors (ADRBs) are suggested as a proxy. Our objective was to determine whether ADRBs documented in electronic medical records (EMRs) of patients prescribed opioids and benzodiazepines could serve as a proxy for identifying PDUD.
Design
A cross-sectional study of PC patients at an urban, academic medical center.
Subjects
264 English-speaking patients (ages 18–60) with chronic pain (≥3 months), receiving ≥1 opioid analgesic or benzodiazepine prescription in the past year, were recruited during outpatient PC visits.
Outcome Measures
Composite International Diagnostic Interview defined DSM-IV diagnoses of past-year PDUD and no disorder. EMRs were reviewed for 15 pre-specified ADRBs (e.g. early refill, stolen medications) in the year before and after study entry. Fisher’s exact test compared frequencies of each ADRB between participants with and without PDUD.
Results
61 participants (23%) met DSM-IV PDUD criteria and 203 (77%) had no disorder; 85% had one or more ADRB documented. Few differences in frequencies of individual behaviors were noted between groups, with only “appearing intoxicated or high” documented more frequently among participants with PDUD (n=10, 16%) vs. no disorder (n=8, 4%), p=0.002. The only common ADRB, “emergency visit for pain,” did not discriminate between those with and without the disorder (82% PDUD vs. 78% no disorder, p=0.6).
Conclusions
EMR documentation of ADRBs is common among PC patients prescribed opioids or benzodiazepines, but unsystematic clinician documentation does not identify PDUDs. Evidence-based approaches are needed.
doi:10.1111/j.1526-4637.2012.01497.x
PMCID: PMC3501607  PMID: 23057631
Prescription drug use disorder; diagnosis; aberrant drug-related behaviors; primary care; chronic pain
14.  Cognitive-Affective and Somatic Side Effects of Morphine and Pentazocine: Side-Effect Profiles in Healthy Adults 
Pain medicine (Malden, Mass.)  2009;11(2):10.1111/j.1526-4637.2009.00680.x.
Objective
The side effects of opioids have been widely investigated, but it is unknown whether the subjective effects of mu agonists and mixed action opioids produce similar symptom profiles. This study examined the structure and predictive validity of somatic and cognitive/affective side-effect profiles of morphine and pentazocine using the Somatic Side Effects Questionnaire and the Cognitive and Affective Side Effects Questionnaire.
Design
The subjects were 122 female and 90 male healthy volunteers that received an intravenous bolus administration of either 0.08 mg/kg of morphine or 0.5 mg/kg pentazocine. Pre- and post-drug experimental pain testing was also performed. Exploratory and confirmatory factor analysis resulted in similar factor structures for both drugs.
Results
The most frequently reported side effects across both drugs involved feeling relaxed, sedation, and feeling in control. At equianalgesic doses, pentazocine had greater aversive side effects than morphine, whereas morphine was more associated with feelings of control and euphoria. For both drugs, females reported greater frequency of negative side effects than males. Using cluster analysis, we identified similar symptom profiles for each drug. These drug-related side-effect profiles were linked with analgesic responses. Specifically, groups that had a more positive side-effect profile experienced the greatest analgesic effect based on changes in ischemic pain sensitivity.
Conclusions
These findings have implications for decisions regarding opioid management of acute, chronic, and malignant pain conditions.
doi:10.1111/j.1526-4637.2009.00680.x
PMCID: PMC3813295  PMID: 19671086
pain; opioid; side effects; sex differences; pain sensitivity; analgesia; cluster analysis
15.  Out-of-pocket Prices of Opioid Analgesics in the United States, 1999-2004 
Pain medicine (Malden, Mass.)  2009;11(2):10.1111/j.1526-4637.2009.00762.x.
OBJECTIVE
To determine the out-of-pocket prices of common opioid analgesics by medication, drug coverage, region, and year.
DESIGN
Retrospective cohort study using 1999-2004 data from the Medical Expenditure Panel Survey (MEPS) and the Medicare Current Beneficiary Survey (MCBS).
SETTING
United States civilian non-institutionalized population.
PATIENTS
Adults who filled prescriptions for opioid analgesics between 1999 and 2004 and who were not enrolled in Medicaid.
OUTCOME MEASURES
Prices of prescribed analgesics were collected from receipts, medication containers, patient recall, and administrative records (N = 20,026 and 31,500, respectively).
RESULTS
Average out-of-pocket price of an opioid analgesic prescription was around $10, but the estimate is misleading: a typical adult patient without drug coverage paid $12.86 to $61.60 to fill their analgesic prescription, depending on medication. The extended-release formulations cost more than double the “immediate release” prices. For the analgesics studied, drug coverage lowered out-of-pocket prices by 50% to 85%, but market prices increased at a rate of 5.7% to 9% per year with little regional variation. Data did not include prices for medications not prescribed or prescribed, but not acquired.
CONCLUSIONS
Independent of the diagnosis, patients’ out-of-pocket price for prescribed analgesics fluctuated freely in the United States across time, region, and coverage status. These fluctuations potentially distort the delivery of effective pain management and further burden an already afflicted population.
doi:10.1111/j.1526-4637.2009.00762.x
PMCID: PMC3811926  PMID: 20002589
opioid; analgesics; cohort; commerce; health expenditures; Medicare
16.  The Brief Pain Inventory and its “Pain at its Worst in the last 24 Hours” Item: Clinical Trial Endpoint Considerations* 
Pain medicine (Malden, Mass.)  2010;11(3):337-346.
Context
In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of Patient-Reported Outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures which can be considered by sponsors and investigators involved in PRO research and drug registration trials.
Objective
In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the “pain at its worst in the last 24 hours” item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint.
Results and Conclusions
After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its “pain at its worst in the last 24 hours” item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.
doi:10.1111/j.1526-4637.2009.00774.x
PMCID: PMC3806650  PMID: 20030743
Pain Measurement; Patient Outcome Assessment; United States Food and Drug Administration; Drug Labeling
17.  Measurement of Affective and Activity Pain Interference Using the Brief Pain Inventory (BPI): Cancer and Leukemia Group B 70903* 
Pain medicine (Malden, Mass.)  2012;13(11):1417-1424.
Objective
The Brief Pain Inventory (BPI) was designed to yield separate scores for pain intensity and interference. It has been proposed that the pain interference factor can be further broken down into unique factors of affective (e.g., mood) and activity (e.g., work) interference. The purpose of this analysis was to confirm this affective/activity interference dichotomy.
Patients and Methods
A retrospective confirmatory factor analysis was completed for a sample of 184 individuals diagnosed with castrate-resistant prostate cancer (Age 40–86, M = 65.46, 77% White Non-Hispanic) who had been administered the BPI as part of Cancer and Leukemia Group B (CALGB) trial 9480. A one-factor model was compared against two-factor and three-factor models that were developed based on the design of the instrument.
Results
Root mean squared error of approximation (0.075), comparative fit index (0.971), and change in chi-square, given the corresponding change in degrees of freedom (13.33, p < .05) values for the three-factor model (i.e., pain intensity, activity interference, and affective interference) were statistically superior in comparison to the one- and two-factor models. This three-factor structure was found to be invariant across age, mean PSA and hemoglobin levels.
Conclusions
These results confirm that the BPI can be used to quantify the degree to which pain separately interferes with affective and activity aspects of a patient's everyday life. These findings will provide clinical trialists, pharmaceutical sponsors, and regulators with confidence in the flexibility of the BPI as they consider the use of this instrument to assist with understanding the patient experience as it relates to treatment.
doi:10.1111/j.1526-4637.2012.01498.x
PMCID: PMC3796944  PMID: 23110676
Measurement; Cancer Pain; Quality of Life
18.  Defining mild, moderate, and severe pain in persons with multiple sclerosis 
Pain medicine (Malden, Mass.)  2012;13(10):1358-1365.
Objective
To identify empirically-derived cutoffs for mild, moderate, and severe pain
Setting
Community-based survey.
Participants
Convenience sample of 236 individuals with MS and pain.
Intervention
Not applicable.
Main Outcome Measures
0-10 Numeric Rating Scale for pain severity (both average and worst pain) and Brief Pain Inventory for pain interference.
Results
The optimal classification scheme for average pain was 0-2 = mild, 3-5 = moderate, and 6-10 = severe. Alternatively, the optimal classification scheme for worst pain was 0-4 = mild, 5-7 = moderate, 8-10 = severe.
Conclusions
The present study furthers our ability to use empirically-based cutoffs to inform the use of clinical guidelines for pain treatment as well as our understanding of the factors that might impact the cutoffs that are most appropriate for specific pain populations. The results of the present study also add to the existing literature by drawing similarities to studies of other populations but also by highlighting that clear, between-condition differences may exist that warrant using different cutoffs for patients with different medical conditions. Specifically, the present study highlights that cutoffs may be lower for persons with MS than other populations of persons with pain.
doi:10.1111/j.1526-4637.2012.01471.x
PMCID: PMC3473137  PMID: 22925457
Pain; pain severity; pain interference; multiple sclerosis
19.  Age and Sex Trends in Long-term Opioid Use in Two Large American Health Systems Between 2000 and 2005 
Pain medicine (Malden, Mass.)  2009;11(2):248-256.
Objective
To estimate recent age- and sex-specific changes in long-term opioid prescription among patients with chronic pain in two large American Health Systems.
Design
Analysis of administrative pharmacy data to calculate changes in prevalence of long-term opioid prescription (90 days or more during a calendar year) from 2000 to 2005, within groups based on sex and age (18–44, 45–64, and 65 years and older). Separate analyses were conducted for patients with and without a diagnosis of a mood disorder or anxiety disorder. Changes in mean dose between 2000 and 2005 were estimated, as were changes in the rate of prescription for different opioid types (short-acting, long-acting, and non-Schedule 2).
Patients
Enrollees in HealthCore (N = 2,716,163 in 2000) and Arkansas Medicaid (N = 115,914 in 2000).
Results
Within each of the age and sex groups, less than 10% of patients with a chronic pain diagnosis in HealthCore, and less than 33% in Arkansas Medicaid, received long-term opioid prescriptions. All age, sex, and anxiety/depression groups showed similar and statistically significant increases in long-term opioid prescription between 2000 and 2005 (35–50% increase). Per-patient daily doses did not increase.
Conclusions
No one group showed especially large increases in long-term opioid prescriptions between 2000 and 2005. These results argue against a recent epidemic of opioid prescribing. These trends may result from increased attention to pain in clinical settings, policy or economic changes, or provider and patient openness to opioid therapy. The risks and benefits to patients of these changes are not yet established.
doi:10.1111/j.1526-4637.2009.00740.x
PMCID: PMC3773537  PMID: 20002323
Opioids; Prescriptions; Chronic Pain; Disparities—Gender; Aged; Mood; Anxiety
20.  Primary care providers’ views on chronic pain management among high-risk patients in safety net settings 
Pain medicine (Malden, Mass.)  2012;13(9):1141-1148.
Objective
We examined chronic pain management practices and confidence and satisfaction levels in treating chronic pain among primary care providers (PCPs) who cared for high-risk patients in safety net health settings.
Design
We recruited PCPs (n=61) through their HIV-infected patients who were enrolled in a longitudinal study on pain, use and misuse of opioid analgesics (Pain Study). We asked PCPs to complete a questionnaire about all of their patients in their practice on the prevalence of chronic pain and illicit substance use, use of opioid analgesics, confidence and satisfaction levels in treating chronic pain, and likelihood of prescribing opioid analgesics in response to clinical vignettes.
Results
All PCPs cared for at least some patients with chronic pain, and the majority prescribed opioid analgesics for its treatment. All PCPs cared for at least some patients who used illicit substances. PCPs reported low confidence and satisfaction levels in treating chronic pain. The majority (73.8%) of PCPs were highly likely to prescribe opioid analgesics to a patient without a history of substance use who had chronic pain. The majority (88.5%) were somewhat to highly likely to prescribe opioid analgesics to a patient with a prior history of substance use but not active use. Most (67.2%) were somewhat to highly likely to prescribe opioids to a patient with active substance use.
Conclusion
In order to improve PCPs confidence and satisfaction in managing chronic pain, further work should explore the root causes of low confidence and satisfaction and also explore possible remedies.
doi:10.1111/j.1526-4637.2012.01443.x
PMCID: PMC3443261  PMID: 22846057
chronic pain; opioid analgesics; substance use; primary care provider views
21.  Do Patients Know They Are on Pain Medication Agreements? Results from a Sample of High-Risk Patients on Chronic Opioid Therapy 
Pain medicine (Malden, Mass.)  2012;13(9):1174-1180.
Objective
Pain medicine agreements are frequently recommended for use with high-risk patients on chronic opioid therapy. We assessed how consistently pain medicine agreements were used and whether patients were aware that they had signed a pain medicine agreement in a sample of HIV-infected adults prescribed chronic opioid treatment.
Design
We recruited patients from a longitudinal cohort of community-based HIV-infected adults and recruited the patients’ Primary Care Providers (PCPs). Patients completed in-person interviews and PCPs completed mail-based questionnaires about the patients’ use of pain medicine agreements. Among patients prescribed chronic opioid therapy, we analyzed the prevalence of pain medicine agreement use, patient factors associated with their use, and agreement between patient and clinician reports of pain agreements.
Results
We had 84 patient-clinician dyads, representing 38 PCPs. 72.8% of patients fit diagnostic criteria for a lifetime substance use disorder. PCPs reported using pain medicine agreements with 42.9% of patients. Patients with pain medicine agreements were more likely to be smokers (91.7% vs. 58.3%; p=.001) and had higher mean scores on the Screener and Opioid Assessment for Patients with Pain (μ=26.0 (SD=9.7) vs. μ=19.5 (SD=9.3); p=.003). Patients reported having a pain medicine agreement with a sensitivity of 61.1% and a specificity of 64.6%.
Conclusion
In a high risk sample, clinicians were using agreements at a low rate, but were more likely to use them with patients at highest risk of misuse. Patients exhibited low awareness of whether they signed a pain medicine agreement.
doi:10.1111/j.1526-4637.2012.01430.x
PMCID: PMC3443332  PMID: 22757769
pain medicine agreements; opioid analgesics; chronic pain; patient-clinician agreement
22.  Preparing to Implement a Self-Management Program for Back Pain in New York City Senior Centers: What Do Prospective Consumers Think? 
Pain medicine (Malden, Mass.)  2010;11(3):405-415.
Objective
Prior to testing the feasibility/potential efficacy of a newly developed self-management pain program for seniors with back pain, this study sought to: 1) determine prospective consumers’ prior exposure to self-management pain programs, 2) determine their willingness to participate in the new program; and 3) ascertain perceived barriers/facilitators to program participation.
Design
Cross-sectional survey.
Setting
Six senior centers located in New York City.
Participants
We enrolled a race/ethnicity stratified (African American, Hispanic, or non-Hispanic White) sample of 90 subjects who were ages 60 years or older and had chronic back pain.
Results
While 60% of non-Hispanic Whites reported prior participation in a self-management pain program, fewer Hispanic (23%) and African Americans (20%) participants reported prior participation. Most participants (80%) were strongly willing to participate in the new program. Multivariate analyses revealed that only pain intensity had a trend toward significance (p=.07), with higher pain scores associated with greater willingness to participate. Few barriers to participation were identified, however, respondents felt that tailoring the course to best meet the needs of those with physical disabilities, providing flexibility in class timing, and informing individuals about program benefits prior to enrollment could help maximize program reach. No race/ethnicity differences were identified with respect to willingness to participate or program participation barriers.
Conclusions
These data support efforts to disseminate self-management pain programs in older populations, particularly minority communities. The recommendations made by participants can help to guide implementation efforts of the newly developed pain program and may help to enhance both their reach and success.
doi:10.1111/j.1526-4637.2009.00783.x
PMCID: PMC3746988  PMID: 20088858
23.  The Effect of a Translating Research into Practice (TRIP)-Cancer Intervention on Cancer Pain Management in Older Adults in Hospice 
Pain medicine (Malden, Mass.)  2012;13(8):1004-1017.
Pain is a major concern for individuals with cancer, particularly older adults who make up the largest segment of individuals with cancer and have some of the most unique pain challenges. One of the priorities of hospice is to provide a pain free death, and while outcomes are better in hospice, patients still die with poorly controlled pain.
Objective
This paper reports on the results of a Translating Research Into Practice intervention designed to promote the adoption of evidence-based pain practices for older adults with cancer in community-based hospice.
Setting
This IRB approved study was a cluster randomized trial implemented in sixteen Midwestern hospices.
Methods
Retrospective medical records from newly admitted patients were used to determine the intervention effect. Additionally, survey and focus group data gathered from hospice staff at the completion of the intervention phase were analyzed.
Results
Improvement on the Cancer Pain Practice Index, an overall composite outcome measure of evidence-based practices for the experimental sites was not significantly greater than control sites. Decrease in patient pain severity from baseline to post intervention in the experimental group was greater, however, the result was not statistically significant (p=0.1032).
Conclusions
Findings indicate a number of factors may impact implementation of multi-component interventions, including unique characteristics and culture of the setting, the level of involvement with the change processes, competing priorities and confounding factors, and complexity of the innovation (practice change). Our results suggest future study is needed on specific factors to target when implementing a community-based hospice intervention, including determining and measuring intervention fidelity prospectively.
doi:10.1111/j.1526-4637.2012.01405.x
PMCID: PMC3422373  PMID: 22758921
elderly; cancer pain; pain assessment; pain management; hospice
24.  Regional anesthesia as compared to general anesthesia for surgery in geriatric patients with hip fracture: Does it decrease morbidity, mortality and healthcare costs? Results of a single-centered study 
Pain medicine (Malden, Mass.)  2012;13(7):948-956.
Introduction
Hip fracture in geriatric patients has a substantial economic impact and represents a major cause of morbidity and mortality in this population. At our institution, a regional anesthesia program was instituted for patients undergoing surgery for hip fracture. This retrospective cohort review examines the effects of regional anesthesia (from mainly after July 2007) versus general anesthesia (mainly prior to July 2007) on morbidity, mortality and hospitalization costs.
Methods
This retrospective cohort study involved data collection from electronic and paper charts of 308 patients who underwent surgery for hip fracture from September 2006 to December 2008. Data on postoperative morbidity, in-patient mortality, and cost of hospitalization (as estimated from data on hospital charges) were collected and analyzed. Seventy-three patients received regional anesthesia and 235 patients received general anesthesia. During July 2007, approximately halfway through the study period, a regional anesthesia and analgesia program was introduced.
Results
The average cost of hospitalization in patients who receive surgery for hip fracture was no different between patients who receive regional or general anesthesia ($16,789 + 631 v. $16,815 + 643, respectively, p = 0.9557). Delay in surgery and intensive care unit admission resulted in significantly higher hospitalization costs. Age, male gender, African-American race and intensive care unit admission were associated with increased in-hospital mortality. In-hospital mortality and rates of readmission are not statistically different between the two anesthesia groups.
Conclusions
There is no difference in postoperative morbidity, rates of re-hospitalization, in-patient mortality or hospitalization costs in geriatric patients undergoing regional or general anesthesia for repair of hip fracture. Delay in surgery beyond 3 days and intensive care unit admission both increase cost of hospitalization.
doi:10.1111/j.1526-4637.2012.01402.x
PMCID: PMC3730262  PMID: 22758782
25.  Patterns and Correlates of Prescription Opioid Use in OEF/OIF Veterans with Chronic Non-Cancer Pain 
Pain medicine (Malden, Mass.)  2011;12(10):1502-1509.
Objectives
Little is known about the treatment Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans receive for chronic non-cancer pain (CNCP). We sought to describe the prevalence of prescription opioid use, types and doses of opioids received, and identify correlates of receiving prescription opioids for CNCP among OEF/OIF veterans.
Design
Retrospective review of VA administrative data.
Setting
Ambulatory clinics within a VA regional healthcare network.
Patients
OEF/OIF veterans who had at least 3 elevated pain screening scores within a 12-month period in 2008. Within this group, those prescribed opioids (n=485) over the next 12 months were compared to those not prescribed opioids (n=277). In addition, patients receiving opioids short term (<90 days, n=284) were compared to patients receiving them long-term (≥90 consecutive days, n=201).
Results
Of 762 OEF/OIF veterans with CNCP, 64% were prescribed at least one opioid medication over the 12 months following their index dates. Of those prescribed an opioid, 59% were prescribed opioids short-term and 41% were prescribed opioids long-term. The average morphine-equivalent opioid dose for short-term users was 23.7 mg (SD=20.5) compared with 40.8 mg (SD=36.1) for long-term users (p<0.001). Fifty-one percent of long-term opioid users were prescribed short-acting opioids only and one-third were also prescribed sedative-hypnotics. In adjusted analyses, diagnoses of low back pain, migraine headache, post-traumatic stress disorder, and nicotine use disorder were associated with an increased likelihood of receiving an opioid prescription.
Conclusion
Prescription opioid use is common among OEF/OIF veterans with CNCP and is associated with several pain diagnoses and medical conditions.
doi:10.1111/j.1526-4637.2011.01226.x
PMCID: PMC3724513  PMID: 21899715
Chronic pain; Opioids; Veteran; Pain/drug therapy

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