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1.  Patients' views on responsibility for the management of musculoskeletal disorders – A qualitative study 
Background
Musculoskeletal disorders are very common and almost inevitable in an individual's lifetime. Enabling self-management and allowing the individual to take responsibility for care is stated as desired in the management of these disorders, but this may be asking more than people can generally manage. A willingness among people to take responsibility for musculoskeletal disorders and not place responsibility out of their hands or on employers but to be shared with medical professionals has been shown. The aim of the present study was to describe how people with musculoskeletal disorders think and reason regarding responsibility for prevention, treatment and management of the disorder.
Methods
Individual interviews with a strategic sample of 20 individuals with musculoskeletal disorders were performed. The interviews were tape-recorded, transcribed verbatim and analysed according to qualitative content analysis.
Results
From the interviews an overarching theme was identified: own responsibility needs to be met. The analysis revealed six interrelated categories: Taking on responsibility, Ambiguity about responsibility, Collaborating responsibility, Complying with recommendations, Disclaiming responsibility, and Responsibility irrelevant. These categories described different thoughts and reasoning regarding the responsibility for managing musculoskeletal disorders. Generally the responsibility for prevention of musculoskeletal disorders was described to lie primarily on society/authorities as they have knowledge of what to prevent and how to prevent it. When musculoskeletal disorders have occurred, health care should provide fast accessibility, diagnosis, prognosis and support for recovery. For long-term management, the individuals themselves are responsible for making the most out of life despite disorders.
Conclusion
No matter what the expressions of responsibility for musculoskeletal disorders are, own responsibility needs to be met by society, health care, employers and family in an appropriate way, with as much or as little of the "right type" of support needed, based on the individual's expectations.
doi:10.1186/1471-2474-10-103
PMCID: PMC2753559  PMID: 19686602
2.  Studying the association between musculoskeletal disorders, quality of life and mental health. A primary care pilot study in rural Crete, Greece 
Background
The burden of musculoskeletal disorders (MSD) on the general health and well-being of the population has been documented in various studies. The objective of this study was to explore the association between MSD and the quality of life and mental health of patients and to discuss issues concerning care seeking patterns in rural Greece.
Methods
Patients registered at one rural Primary Care Centre (PCC) in Crete were invited to complete the Nordic Musculoskeletal Questionnaire (NMQ) for the analysis of musculoskeletal symptoms, together with validated instruments for measuring health related quality of life (SF-36) and mental distress (GHQ-28).
Results
The prevalence rate of MSD was found to be 71.2%, with low back and knee pain being the most common symptoms. Most conditions significantly impaired the quality of life, especially the physical dimensions of SF-36. Depression was strongly correlated to most MSD (p < 0.001). Multiple logistic analyses revealed that patients who consulted the PCC due to MSD were likely to have more mental distress or impaired physical functioning compared to those who did not.
Conclusion
Musculoskeletal disorders were common in patients attending the rural PCC of this study and were associated with a poor quality of life and mental distress that affected their consultation behaviour.
doi:10.1186/1471-2474-10-143
PMCID: PMC2785760  PMID: 19930570
3.  Musculoskeletal disorders in physically active conscripts: a one-year follow-up study in the Finnish Defence Forces 
Background
Musculoskeletal disorders (MSDs) are an important cause for morbidity in military service. They result in disabilities needing long-term rehabilitation and functional impairment leading to premature discharge from military service. The purpose of the study was to investigate the incidence and nature of MSDs in Finnish conscripts.
Methods
Two successive arrivals of 18–28-yr-old male conscripts (N = 955, median age 19) were followed for six months. MSDs, including overuse and acute injuries, treated at the garrison clinic were identified and analysed.
Results
During the 12-month study period there were 437 outpatient clinic visits in 955 persons. The occurrence rate was 33% during 6-month service while the event-based incidence was 3.3 per 1000 person-days. Occurrence peaked in summer months. The most common types of MSDs were low back pain (LBP, 20%), lower limb overuse injuries (16%) and sprains or strains (13%). Disorders mostly occurred in combat training in combat gear (40%) and during marching on foot or bicycle (28%). Overuse-related MSDs were more prevalent (66%) than traumatic ones (34%). One-third (34%) of the MSDs were recurrent and 66% were new ones. Disorders of the back and the knee were most frequently recurrent conditions (44% for both). Fractures, knee ligament ruptures, dislocations and muscle strains accounted for the highest number of service days lost. Twenty-four (2.5%) out of 955 conscripts were prematurely discharged due to MSDs.
Conclusion
Preventive measures during military service should be targeted at decreasing low back pain and lower limb overuse injuries, because these inflict the largest burden of MSDs and tend to have a chronic nature.
doi:10.1186/1471-2474-10-89
PMCID: PMC2724399  PMID: 19624829
4.  Analyzing musculoskeletal neck pain, measured as present pain and periods of pain, with three different regression models: a cohort study 
Background
In the literature there are discussions on the choice of outcome and the need for more longitudinal studies of musculoskeletal disorders. The general aim of this longitudinal study was to analyze musculoskeletal neck pain, in a group of young adults. Specific aims were to determine whether psychosocial factors, computer use, high work/study demands, and lifestyle are long-term or short-term factors for musculoskeletal neck pain, and whether these factors are important for developing or ongoing musculoskeletal neck pain.
Methods
Three regression models were used to analyze the different outcomes. Pain at present was analyzed with a marginal logistic model, for number of years with pain a Poisson regression model was used and for developing and ongoing pain a logistic model was used. Presented results are odds ratios and proportion ratios (logistic models) and rate ratios (Poisson model). The material consisted of web-based questionnaires answered by 1204 Swedish university students from a prospective cohort recruited in 2002.
Results
Perceived stress was a risk factor for pain at present (PR = 1.6), for developing pain (PR = 1.7) and for number of years with pain (RR = 1.3). High work/study demands was associated with pain at present (PR = 1.6); and with number of years with pain when the demands negatively affect home life (RR = 1.3). Computer use pattern (number of times/week with a computer session ≥ 4 h, without break) was a risk factor for developing pain (PR = 1.7), but also associated with pain at present (PR = 1.4) and number of years with pain (RR = 1.2). Among life style factors smoking (PR = 1.8) was found to be associated to pain at present. The difference between men and women in prevalence of musculoskeletal pain was confirmed in this study. It was smallest for the outcome ongoing pain (PR = 1.4) compared to pain at present (PR = 2.4) and developing pain (PR = 2.5).
Conclusion
By using different regression models different aspects of neck pain pattern could be addressed and the risk factors impact on pain pattern was identified. Short-term risk factors were perceived stress, high work/study demands and computer use pattern (break pattern). Those were also long-term risk factors. For developing pain perceived stress and computer use pattern were risk factors.
doi:10.1186/1471-2474-10-73
PMCID: PMC2714495  PMID: 19545386
5.  How well do questionnaires on symptoms in neck-shoulder disorders capture the experiences of those who suffer from neck-shoulder disorders? A content analysis of questionnaires and interviews 
Background
Previous research has indicated neck-shoulder disorders to have a fluctuating course incorporating a variety of symptoms. These findings awoke our interest to make a comparison between symptoms experienced by people affected with the disorder and the content of questionnaires that assess pain and other symptoms in neck-shoulder disorders. Thus the aims of this study were: -to explore the symptoms experienced by people with non-specific neck-shoulder problems, as well as experiences of nuances and temporal variations (fluctuations) of symptoms; -to investigate which sources were used in the development of ten questionnaires for assessing pain and other symptoms in the neck-shoulder; -to analyse the item content of the questionnaires; -to analyse the correspondence between the item content of the questionnaires and the symptoms described by the informants.
Methods
Content analysis of interviews with 40 people with non-specific neck-shoulder pain, and 10 questionnaires used to assess pain and other symptoms in neck-shoulder disorders.
Results
The interviews revealed a variety of symptoms indicating a bodily, mental/cognitive, and emotional engagement, and more general and severe symptoms than are usually considered in neck-shoulder questionnaires. Taking all questionnaires together many of the symptoms were considered, but most questionnaires only included a few of them. The informants were able to distinguish fluctuation of symptoms, and a variety of different qualities which were not usually considered in the questionnaires. Only two questionnaires had made use of the opinions of affected people in the development.
Conclusion
Few of the questionnaires had made use of the experiences of affected people in the development. The correspondence between the symptoms expressed by those affected and the content of the questionnaires was low. A variety of symptoms were expressed by the interviewees, and the participants were also able to distinguish nuances and fluctuations of symptoms. The present study points to the importance of other aspects than just pain and physical functioning as clinical trial outcome measures related to neck-shoulder disorders. To develop a condition-specific questionnaire, it is important to decide on the specific symptoms for the condition. Using the experiences of those affected, in combination with relevant research and professional knowledge, can enhance the validity of the questionnaires.
doi:10.1186/1471-2474-10-30
PMCID: PMC2670265  PMID: 19272142
6.  The panorama of future sick-leave diagnoses among young adults initially long-term sickness absent due to neck, shoulder, or back diagnoses. An 11-year prospective cohort study 
Background
Little is known about future sick-leave diagnoses among individuals on long-term sickness absence. The aim of this study was to describe the panorama of sick-leave diagnoses over time among young adults initially sick-listed for ≥ 28 days due to back, neck, or shoulder diagnoses
Methods
An 11-year prospective population-based cohort study including all 213 individuals in a Swedish municipality who, in 1985, were aged 25–34 years and had a new sick-leave spell ≥ 28 days due to neck, shoulder, or back diagnoses.
Results
Over the 11-year period, the young adults in this cohort had 176,825 sick-leave days in 7,878 sick-leave periods (in 4,610 sick-leave spells) due to disorders in 17 of the 18 ICD-8 diagnostic categories (International Classification of Diseases, Revision 8). Musculoskeletal or mental diagnoses accounted for most of the sick-leave days, whereas most of the sick-leave periods were due to musculoskeletal, respiratory, or infectious disorders, or to unclassified symptoms. Most cohort members had had four to eight different sick-leave diagnoses over the 11 years, although some had had up to 11 diagnoses. Only two individuals (1%) had been sickness absent solely due to musculoskeletal diagnoses.
Conclusion
Although the young adults initially were sick listed with back, neck, or shoulder diagnoses, their sickness absence during the follow up were due to a wide variety of other medical diagnoses. It might be that the ill-health content of sickness absence due to back pain is greater than usually assumed. More research on prognoses of sick-leave diagnoses among long-term sick listed is warranted.
doi:10.1186/1471-2474-10-84
PMCID: PMC2719585
7.  Cross-sectional analysis of baseline differences of candidates for rotator cuff surgery: a sex and gender perspective 
Background
The word "sex" refers to biological differences between men and women. Gender refers to roles, behaviors, activities, and attributes that a given society considers appropriate for men and women. Traditionally, treatment decisions have been based on patient's sex without including the gender. Assessment of disability secondary to musculoskeletal problems would not be complete or accurate unless potentially relevant biological and non-biological aspects of being a man or woman are taken into consideration. The purposes of this study were to: 1) investigate the difference in pre-operative characteristics between men and women who were candidates for rotator cuff surgery; and, 2) assess the relationship between level of disability and factors that represent sex and factors that signify gender.
Method
This was a cross-sectional study. The primary outcome measure of disability was a disease-specific outcome measure, the Western Ontario Rotator Cuff (WORC) index, and independent variables were sex, age, hand dominance, shoulder side involvement, BMI, co-morbidity, medication use, work status, smoking habits, strength, range of motion, level of pathology, concurrent osteoarthritis, expectations for recovery, and participation restriction. Parametric, non-parametric, univariable, subgroup, and multivariable analyses were conducted.
Results
One hundred and seventy patients were included in the study. The mean age was 57 ± 11, 85 were females. Women reported higher levels of disability despite similar or lower levels of pathology. Scores of the WORC were strongly influenced by factors that represented "gender" such as participation restriction (F = 28.91, p < 0.0001) and expectations for improved activities of daily living (F = 5.80, p = 0.004). Painfree combined range of motion, which represented an interaction between "sex" and "gender" was also associated with disability after being adjusted for all other relevant baseline factors (F = 25.82, p < 0.0001).
Conclusion
Gender-related factors such as expectations and participation limitations have an independent impact on disability in men and women undergoing rotator cuff related surgery.
doi:10.1186/1471-2474-10-26
PMCID: PMC2656456  PMID: 19239706
8.  Cognitive impairment in patients with Fibromyalgia syndrome as assessed by the Mini-Mental State Examination 
Background
This study evaluated the frequency of cognitive impairment in patients with Fibromyalgia syndrome (FMS) using the Mini Mental State Examination (MMSE).
Methods
We analyzed baseline data from all 46 patients with FMS and 92 age- and sex-matched controls per diagnosis of neuropathic (NeP) or mixed pain (MP) selected from a larger prospective study.
Results
FMS had a slight but statistically significant lower score in the adjusted MMSE score (26.9; 95% CI 26.7-27.1) than either NeP (27.3; 95% CI 27.2-27.4) or MP (27.3; 27.2-27.5). The percentage of patients with congnitive impairment (adjusted MMSE ≤ 26) was numerically higher in FMS (15%; 95% CI 6.3-29) compared with NeP (5%; 95% CI 1.8-12.2) or MP (5%; 95% CI 1.8-12.2) and higher than in the same age stratum of the general population (0.05%).
Conclusions
Compared with the population reference value, patients with FMS showed high frequency of cognitive impairment.
doi:10.1186/1471-2474-10-162
PMCID: PMC2811106  PMID: 20025750
9.  The prevalence of neovascularity in patients clinically diagnosed with rotator cuff tendinopathy 
Background
Shoulder dysfunction is common and pathology of the rotator cuff tendons and subacromial bursa are considered to be a major cause of pain and morbidity. Although many hypotheses exist there is no definitive understanding as to the origin of the pain arising from these structures. Research investigations from other tendons have placed intra-tendinous neovascularity as a potential mechanism of pain production. The prevalence of neovascularity in patients with a clinical diagnosis of rotator cuff tendinopathy is unknown. As such the primary aim of this pilot study was to investigate if neovascularity could be identified and to determine the prevalence of neovascularity in the rotator cuff tendons and subacromial bursa in subjects with unilateral shoulder pain clinically assessed to be rotator cuff tendinopathy. The secondary aims were to investigate the association between the presence of neovascularity and pain, duration of symptoms, and, neovascularity and shoulder function.
Methods
Patients with a clinical diagnosis of unilateral rotator cuff tendinopathy referred for a routine diagnostic ultrasound (US) scan in a major London teaching hospital formed the study population. At referral patients were provided with an information document. On the day of the scan (on average, at least one week later) the patients agreeing to participate were taken through the consent process and underwent an additional clinical examination prior to undergoing a bilateral grey scale and colour Doppler US examination (symptomatic and asymptomatic shoulder) using a Philips HDI 5000 Sono CT US machine. The ultrasound scans were performed by one of two radiologists who recorded their findings and the final assessment was made by a third radiologist blinded both to the clinical examination and the ultrasound examination. The findings of the radiologists who performed the scans and the blinded radiologist were compared and any disagreements were resolved by consensus.
Results
Twenty-six patients agreed to participate and formed the study population. Of these, 6 subjects were not included in the final assessment following the pre-scan clinical investigation. This is because one subject had complete cessation of symptoms between the time of the referral and entry into the trial. Another five had developed bilateral shoulder pain during the same period. The mean age of the 20 subjects forming the study population was 50.2 (range 32-69) years (SD = 10.9) and the mean duration of symptoms was 22.6 (range .75 to 132) months (SD = 40.1). Of the 20 subjects included in the formal analysis, 13 subjects (65%) demonstrated neovascularity in the symptomatic shoulder and 5 subjects (25%) demonstrated neovascularity in the asymptomatic shoulder. The subject withdrawn due to complete cessation of symptoms was not found to have neovascularity in either shoulder and of the 5 withdrawn due to bilateral symptoms; two subjects were found to have signs of bilateral neovascularity, one subject demonstrated neovascularity in one shoulder and two subjects in neither shoulder.
Conclusions
This study demonstrated that neovascularity does occur in subjects with a clinical diagnosis of rotator cuff tendinopathy and to a lesser extent in asymptomatic shoulders. In addition, the findings of this investigation did not identify an association between the presence of neovascularity; and pain, duration of symptoms or shoulder function. Future research is required to determine the relevance of these findings.
doi:10.1186/1471-2474-10-163
PMCID: PMC2813234  PMID: 20025761
10.  Association between knee alignment and knee pain in patients surgically treated for medial knee osteoarthritis by high tibial osteotomy. A one year follow-up study 
Background
The association between knee alignment and knee pain in knee osteoarthritis (OA) is unclear. High tibial osteotomy, a treatment option in knee OA, alters load from the affected to the unaffected compartment of the knee by correcting malalignment. This surgical procedure thus offers the possibility to study the cross-sectional and longitudinal association of alignment to pain. The aims were to study 1) the preoperative association of knee alignment to preoperative knee pain and 2) the association of change in knee alignment with surgery to change in knee pain over time in patients operated on for knee OA by high tibial osteotomy.
Methods
182 patients (68% men) mean age 53 years (34 - 69) with varus alignment having tibial osteotomy by the hemicallotasis technique for medial knee OA were consecutively included. Knee alignment was assessed by the Hip-Knee-Ankle (HKA) angle from radiographs including the hip and ankle joints. Knee pain was measured by the subscale pain (0 - 100, worst to best scale) of the Knee injury and Osteoarthritis Outcome Score (KOOS) preoperatively and at one year follow-up. To estimate the association between knee alignment and knee pain multivariate regression analyses were used.
Results
Mean preoperative varus alignment was 170 degrees (153 - 178) and mean preoperative KOOS pain was 42 points (3 - 86). There was no association between preoperative varus alignment and preoperative KOOS pain, crude analysis 0.02 points (95% CI -0.6 - 0.7) change in pain with every degree of HKA angle, adjusted analysis 0.3 points (95% CI -1.3 - 0.6).
The mean postoperative knee alignment was 184 degrees (171 - 185). The mean change in knee alignment was 13 degrees (0 - 30). The mean change in KOOS pain was 32 (-16 - 83). There was neither any association between change in knee alignment and change in KOOS pain over time, crude analysis 0.3 point (95% CI -0.6 - 1.2), adjusted analysis 0.4 points (95% CI 0.6 - 1.4).
Conclusion
We found no association between knee alignment and knee pain in patients with knee OA indicating that alignment and pain are separate entities, and that the degree of preoperative malalignment is not a predictor of knee pain after high tibial osteotomy.
doi:10.1186/1471-2474-10-154
PMCID: PMC2796991  PMID: 19995425
11.  Does physical activity change predict functional recovery in low back pain? Protocol for a prospective cohort study 
Background
Activity advice and prescription are commonly used in the management of low back pain (LBP). Although there is evidence for advising patients with LBP to remain active, facilitating both recovery and return to work, to date no research has assessed whether objective measurements of free living physical activity (PA) can predict outcome, recovery and course of LBP.
Methods
An observational longitudinal study will investigate PA levels in a cohort of community-dwelling working age adults with acute and sub-acute LBP. Each participant's PA level, functional status, mood, fear avoidance behaviours, and levels of pain, psychological distress and occupational activity will be measured on three occasions during for 1 week periods at baseline, 3 months, and 1 year. Physical activity levels will be measured by self report, RT3 triaxial accelerometer, and activity recall questionnaires. The primary outcome measure of functional recovery will be the Roland Morris Disability Questionnaire (RMDQ). Free living PA levels and changes in functional status will be quantified in order to look at predictive relationships between levels and changes in free living PA and functional recovery in a LBP population.
Discussion
This research will investigate levels and changes in activity levels of an acute LBP cohort and the predictive relationship to LBP recovery. The results will assess whether occupational, psychological and behavioural factors affect the relationship between free living PA and LBP recovery. Results from this research will help to determine the strength of evidence supporting international guidelines that recommend restoration of normal activity in managing LBP.
Trial registration
[Clinical Trial Registration Number, ACTRN12609000282280]
doi:10.1186/1471-2474-10-136
PMCID: PMC2777147  PMID: 19895697
12.  Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain 
Background
Headache is a highly prevalent disorder. Irrespective of the headache diagnosis it is often accompanied with neck pain and -stiffness. Due to this common combination of headache and neck pain, physical treatments of the cervical spine are often considered. The additional value of these treatments to standard medical care or usual care (UC) is insufficiently documented.
We therefore wanted to compare the treatment effects of UC alone and in combination with manual therapy (MT) in patients with a combination of headache and neck pain. UC consisted of a stepped treatment approach according to the Dutch General Practitioners Guideline for headache, the additional MT consisted of articular mobilisations and low load exercises.
Due to insufficient enrolment the study was terminated prematurely. We aim to report not only our preliminary clinical findings but also to discuss the encountered difficulties and to formulate recommendations for future research.
Methods
A randomised clinical trial was conducted. Thirty-seven patients were included and randomly allocated to one of both treatment groups. The treatment period was 6 weeks, with follow-up measurements at weeks 7, 12 and 26. Primary outcome measures were global perceived effect (GPE) and the impact of the headache using the Headache Impact Test (HIT-6). Reduction in headache frequency, pain intensity, medication intake, absenteeism and the use of additional professional help were secondary outcome measures
Results
Significant improvements on primary and secondary outcome measures were recorded in both treatment groups. No significant differences between both treatment groups were found. The number of recruited patients remained low despite various strategies.
Conclusion
It appears that both treatment strategies can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed.
Trial registration number
NCT00298142
doi:10.1186/1471-2474-10-115
PMCID: PMC2758835  PMID: 19775434
13.  Short-term effects of implemented high intensity shoulder elevation during computer work 
Background
Work-site strength training sessions are shown effective to prevent and reduce neck-shoulder pain in computer workers, but difficult to integrate in normal working routines. A solution for avoiding neck-shoulder pain during computer work may be to implement high intensity voluntary contractions during the computer work. However, it is unknown how this may influence productivity, rate of perceived exertion (RPE) as well as activity and rest of neck-shoulder muscles during computer work. The aim of this study was to investigate short-term effects of a high intensity contraction on productivity, RPE and upper trapezius activity and rest during computer work and a subsequent pause from computer work.
Methods
18 female computer workers performed 2 sessions of 15 min standardized computer mouse work preceded by 1 min pause with and without prior high intensity contraction of shoulder elevation. RPE was reported, productivity (drawings per min) measured, and bipolar surface electromyography (EMG) recorded from the dominant upper trapezius during pauses and sessions of computer work. Repeated measure ANOVA with Bonferroni corrected post-hoc tests was applied for the statistical analyses.
Results
The main findings were that a high intensity shoulder elevation did not modify RPE, productivity or EMG activity of the upper trapezius during the subsequent pause and computer work. However, the high intensity contraction reduced the relative rest time of the uppermost (clavicular) trapezius part during the subsequent pause from computer work (p < 0.04).
Conclusion
Since a preceding high intensity shoulder elevation did not impose a negative impact on perceived effort, productivity or upper trapezius activity during computer work, implementation of high intensity contraction during computer work to prevent neck-shoulder pain may be possible without affecting the working routines. However, the unexpected reduction in clavicular trapezius rest during a pause with preceding high intensity contraction requires further investigation before high intensity shoulder elevations can be recommended as an integrated part of computer work.
doi:10.1186/1471-2474-10-101
PMCID: PMC2731070  PMID: 19664264
14.  Choosing surgery: patients' preferences within a trial of treatments for anterior cruciate ligament injury. A qualitative study 
Background
The objective was to understand patients' views of treatment after acute anterior cruciate ligament (ACL) injury, and their reasons for deciding to request surgery despite consenting to participate in a randomised controlled trial (to 'cross-over').
Methods
Thirty-four in-depth qualitative interviews were conducted with young (aged 18–35), physically active individuals with ACL rupture who were participating in a RCT comparing training and surgical reconstruction with training only. 22/34 were randomised to training only but crossed over to surgery. Of these, 11 were interviewed before surgery, and 11 were interviewed at least 6 months after surgery. To provide additional information, 12 patients were interviewed before randomisation. Interviews were audio-recorded, transcribed and analysed using the Framework approach.
Results
Strong preference for surgery was commonplace and many patients said that they joined the RCT in order to bypass waiting lists. Patients who chose to cross-over described training as time consuming, boring and as unable to provide sufficient results within a reasonable timeframe. Some said their injured knees had given-way; others experienced new knee traumas; and many described their lack of trust in their knee. Patients believed that surgery would provide joint stability. Despite the ostensible satisfaction with surgery, more detailed exploration showed mixed views.
Conclusion
Participants in a trial of treatments for acute ACL injury express a variety of views and beliefs about those treatments, and trial participation happens in the absence of equipoise. Furthermore, opting for surgical reconstruction does not necessarily provide patients with satisfactory outcomes. Definition of successful outcome may require an individualised approach, incorporating patients' as well as surgeons' views before treatment decisions are made.
doi:10.1186/1471-2474-10-100
PMCID: PMC2731720  PMID: 19664258
15.  Principles of brain plasticity in improving sensorimotor function of the knee and leg in healthy subjects: A double-blind randomized exploratory trial 
Background
Principles of brain plasticity is used in the treatment of patients with functional limitations to improve sensorimotor function. Training is included in the treatment of knee injury to improve both patient-reported function and sensorimotor function. However, impairment in sensorimotor function often persists despite training. Therefore, it was suggested that training programs need to be more effective to improve sensorimotor function after knee injury. The aim of the current study was to investigate if principles of brain plasticity that have been successfully used on the hand and foot to improve sensorimotor function can be applied on the knee. We hypothesized that temporary anesthesia of the skin area above and below the knee would improve sensorimotor function of the ipsilateral knee and leg.
Methods
In this first double-blind exploratory study, 28 uninjured subjects (mean age 26 years, range 19–34, 50% women) were randomized to temporary local cutaneous application of anesthetic (EMLA®) (n = 14) or placebo cream (n = 14). Fifty grams of EMLA, or placebo, was applied on the leg 10 cm above and 10 cm below the center of patella, leaving the area around the knee without cream. Measures of sensory function (perception of touch, vibration sense, knee kinesthesia) and motor function (knee muscle strength, hop test) were assessed before and after 90 minutes of treatment with EMLA or placebo. The paired t-test was used for comparisons within groups and the independent t-test for comparisons between groups. The number of subjects needed was determined by an a priori sample size calculation.
Results
No statistically significant or clinically relevant differences were seen over time (before vs. after) in the measures of sensory or motor functions in the EMLA group or in the placebo group. There were no differences between the groups due to treatment effect (EMLA vs. placebo).
Conclusion
We found no effect of temporary cutaneous anesthesia on sensorimotor function of the ipsilateral knee and leg in uninjured subjects. The principles used in this study remain to be tested in subjects with knee injury.
doi:10.1186/1471-2474-10-99
PMCID: PMC2736924  PMID: 19656355
16.  Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison 
Background
Corticosteroid injection and physiotherapy are two commonly prescribed interventions for management of lateral epicondylalgia. Corticosteroid injections are the most clinically efficacious in the short term but are associated with high recurrence rates and delayed recovery, while physiotherapy is similar to injections at 6 weeks but with significantly lower recurrence rates. Whilst practitioners frequently recommend combining physiotherapy and injection to overcome harmful effects and improve outcomes, study of the benefits of this combination of treatments is lacking. Clinicians are also faced with the paradox that the powerful anti-inflammatory corticosteroid injections work well, albeit in the short term, for a non-inflammatory condition like lateral epicondylalgia. Surprisingly, these injections have not been rigorously tested against placebo injections. This study primarily addresses both of these issues.
Methods
A randomised placebo-controlled clinical trial with a 2 × 2 factorial design will evaluate the clinical efficacy, cost-effectiveness and recurrence rates of adding physiotherapy to an injection. In addition, the clinical efficacy and adverse effects of corticosteroid injection beyond that of a placebo saline injection will be studied. 132 participants with a diagnosis of lateral epicondylalgia will be randomly assigned by concealed allocation to one of four treatment groups – corticosteroid injection, saline injection, corticosteroid injection with physiotherapy or saline injection with physiotherapy. Physiotherapy will comprise 8 sessions of elbow manipulation and exercise over an 8 week period. Blinded follow-up assessments will be conducted at baseline, 4, 8, 12, 26 and 52 weeks after randomisation. The primary outcome will be a participant rating of global improvement, from which measures of success and recurrence will be derived. Analyses will be conducted on an intention-to-treat basis using linear mixed and logistic regression models. Healthcare costs will be collected from a societal perspective, and along with willingness-to-pay and quality of life data will facilitate cost-effectiveness and cost-benefit analyses.
Conclusion
This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. Findings from this study will assist in the development of evidence based practice recommendations and potentially the optimisation of resource allocation for rehabilitating lateral epicondylalgia.
Trial registration
Australian New Zealand Clinical Trials Register ACTRN12609000051246
doi:10.1186/1471-2474-10-76
PMCID: PMC2707364  PMID: 19552805
17.  Physiological responses to low-force work and psychosocial stress in women with chronic trapezius myalgia 
Background
Repetitive and stressful work tasks have been linked to the development of pain in the trapezius muscle, although the underlying mechanisms still remain unclear. In earlier studies, it has been hypothesized that chronic muscle pain conditions are associated with imbalance in the autonomic nervous system, predominantly expressed as an increased sympathetic activity. This study investigates whether women with chronic trapezius myalgia show higher muscle activity and increased sympathetic tone at baseline and during repetitive low-force work and psychosocial stress, compared with pain-free controls.
Methods
Eighteen women with chronic trapezius myalgia (MYA) and 30 healthy female controls (CON) were studied during baseline rest, 100 min of repetitive low-force work, 20 min of psychosocial stress (Trier Social Stress Test, TSST), and 80 min recovery. The subjects rated their pain intensity, stress and energy level every 20 min throughout the experiment. Muscle activity was measured by surface electromyography in the trapezius muscle (EMGtrap) and deltoid muscle (EMGdelt). Autonomic reactivity was measured through heart rate (HR), skin conductance (SCL), blood pressure (MAP) and respiration rate (Resp).
Results
At baseline, EMGtrap, stress ratings, and HR were higher in MYA than in CON. Energy ratings, EMGdelt, SCL, MAP and Resp were, however, similar in the two groups. Significant main group effects were found for pain intensity, stress ratings and EMGtrap. Deltoid muscle activity and autonomic responses were almost identical in MYA and CON during work, stress and recovery. In MYA only, pain intensity and stress ratings increased towards the end of the repetitive work.
Conclusion
We found increased muscle activity during uninstructed rest in the painful muscle of a group of women with trapezius myalgia. The present study could not confirm the hypothesis that chronic trapezius myalgia is associated with increased sympathetic activity. The suggestion of autonomic imbalance in patients with chronic local or regional musculoskeletal pain needs to be further investigated.
doi:10.1186/1471-2474-10-63
PMCID: PMC2701407  PMID: 19500420
18.  A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): Study rationale, design, and methods 
Background
Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain.
Methods and design
The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452
Discussion
This study will be the first trial in this area and the information on its effectiveness will allow patients, clinicians and treatment funders to make informed choices regarding this treatment.
Trial Registration
This trial has been registered with Australian New Zealand Clinical Trials Registry. ACTRN12608000270314
doi:10.1186/1471-2474-10-55
PMCID: PMC2702312  PMID: 19473546
19.  The effect of warm-up, static stretching and dynamic stretching on hamstring flexibility in previously injured subjects 
Background
Warm-up and stretching are suggested to increase hamstring flexibility and reduce the risk of injury. This study examined the short-term effects of warm-up, static stretching and dynamic stretching on hamstring flexibility in individuals with previous hamstring injury and uninjured controls.
Methods
A randomised crossover study design, over 2 separate days. Hamstring flexibility was assessed using passive knee extension range of motion (PKE ROM). 18 previously injured individuals and 18 uninjured controls participated. On both days, four measurements of PKE ROM were recorded: (1) at baseline; (2) after warm-up; (3) after stretch (static or dynamic) and (4) after a 15-minute rest. Participants carried out both static and dynamic stretches, but on different days. Data were analysed using Anova.
Results
Across both groups, there was a significant main effect for time (p < 0.001). PKE ROM significantly increased with warm-up (p < 0.001). From warm-up, PKE ROM further increased with static stretching (p = 0.04) but significantly decreased after dynamic stretching (p = 0.013). The increased flexibility after warm-up and static stretching reduced significantly (p < 0.001) after 15 minutes of rest, but remained significantly greater than at baseline (p < 0.001). Between groups, there was no main effect for group (p = 0.462), with no difference in mean PKE ROM values at any individual stage of the protocol (p > 0.05). Using ANCOVA to adjust for the non-significant (p = 0.141) baseline difference between groups, the previously injured group demonstrated a greater response to warm-up and static stretching, however this was not statistically significant (p = 0.05).
Conclusion
Warm-up significantly increased hamstring flexibility. Static stretching also increased hamstring flexibility, whereas dynamic did not, in agreement with previous findings on uninjured controls. The effect of warm-up and static stretching on flexibility was greater in those with reduced flexibility post-injury, but this did not reach statistical significance. Further prospective research is required to validate the hypothesis that increased flexibility improves outcomes.
Trial Registration
ACTRN12608000638336
doi:10.1186/1471-2474-10-37
PMCID: PMC2679703  PMID: 19371432
20.  Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study 
Background
Allogeneic red blood cell transfusion is frequently used in total hip replacement surgery (THR). However, data on the prognosis of transfused patients are sparse. In this study we compared the risk of complications following THR in transfused and non-transfused patients.
Methods
A population-based follow-up study was performed using data from medical databases in Denmark. We identified 28,087 primary THR procedures performed from 1999 to 2007, from which we computed a propensity score for red blood cell transfusion based on detailed data on patient-, procedure-, and hospital-related characteristics. We were able to match 2,254 transfused with 2,254 non-transfused THR patients using the propensity score.
Results
Of the 28,087 THR patients, 9,063 (32.3%) received at least one red blood cell transfusion within 8 days of surgery. Transfused patients had higher 90-day mortality compared with matched non-transfused patients: the adjusted OR was 2.2 (95% confidence interval (CI): 1.2-3.8). Blood transfusion was also associated with increased odds of pneumonia (OR 2.1; CI: 1.2-3.8), whereas the associations with cardiovascular or cerebrovascular events (OR 1.4; CI: 0.9-2.2) and venous thromboembolism (OR 1.2; CI: 0.7-2.1) did not reach statistical significance. The adjusted OR of reoperation due to infection was 0.6 (CI: 0.1-2.9).
Conclusions
Red blood cell transfusion was associated with an adverse prognosis following primary THR, in particular with increased odds of death and pneumonia. Although the odds estimates may partly reflect unmeasured bias due to blood loss, they indicate the need for careful assessment of the risk versus benefit of transfusion even in relation to routine THR procedures.
doi:10.1186/1471-2474-10-167
PMCID: PMC2805607  PMID: 20040083
21.  Articular cartilage mineralization in osteoarthritis of the hip 
Background
The aim of this study was to examine the frequency of articular cartilage calcification in patients with end-stage hip OA. Further, its impact on the clinical situation and the OA severity are analyzed.
Methods
Eighty patients with OA of the hip who consecutively underwent total hip replacement were prospectively evaluated, and 10 controls were included. The patients' X-rays were analyzed for the presence of articular cartilage mineralization. A Harris Hip Score (HHS) was preoperatively calculated for every patient.
Slab specimens from the femoral head of bone and cartilage and an additional square centimeter of articular cartilage from the main chondral defect were obtained from each patient for analysis of mineralization by digital contact radiography (DCR). Histological grading was also performed. In a subset of 20 patients, minerals were characterized with an electron microscope (FE-SEM).
Results
Calcifications were seen in all OA cartilage and slab specimens using DCR, while preoperative X-rays revealed calcification in only 17.5%. None of the control cartilage specimens showed mineralization. There was a highly significant inverse correlation between articular cartilage calcification and preoperative HHS. Histological OA grade correlated positively with the amount of matrix calcification. FE-SEM analysis revealed basic calcium phosphate (BCP) as the predominant mineral; CPPD crystals were found in only two patients.
Conclusions
Articular cartilage calcification is a common event in osteoarthritis of the hip. The amount of calcification correlates with clinical symptoms and histological OA grade.
doi:10.1186/1471-2474-10-166
PMCID: PMC2806335  PMID: 20038300
22.  Design and baseline characteristics of a prospective cohort study for determinants of osteoporotic fracture in community-dwelling elderly Japanese men: the Fujiwara-kyo Osteoporosis Risk in Men (FORMEN) Study 
Background
Osteoporosis and osteoporotic fracture in men are significant public health problems in an aging society. However, information on male osteoporosis remains impressively lacking, especially for Asians. We designed the Fujiwara-kyo Osteoporosis Risk in Men (FORMEN) study as an ancillary study of a cohort study, the Fujiwara-kyo study, to determine risk factors for osteoporotic fractures in Japanese men.
Methods/Design
Design: A community-based single-centre prospective cohort study with at least a 5-year follow-up
Subjects: All the male participants of the Fujiwara-kyo study who were living in the four cities studied, aged 65 years and older, and able to walk without aid from others.
Primary outcome: Incidence of osteoporotic fractures including vertebral and clinical non-vertebral fractures.
Additional outcomes: Change in bone mineral density (BMD), change in hip geometry, onset of receiving benefits from Long-term Care Insurance (LCI), health-related quality of life, and mortality.
Baseline measurements: BMD at the lumbar spine (LS) and hip (TH), hip geometry, vertebral deformity assessment, bone turnover markers, physical and cognitive performance, various medical and lifestyle factors, and geriatric psychosocial measures confirmed by interviews based on self-administrated questionnaires.
Outcome surveillance: Annual mail surveys and a follow-up survey at the fifth year comprising similar items to the baseline study will be used to determine the outcomes. Receipt of benefits from LCI and mortality will be obtained from the city governments.
Current status: The baseline study was conducted for 2174 eligible men, and 2012 completed the study and were eligible for follow-up. Prevalence rates of osteoporosis (BMD 2.5 SD or more below the young adult mean (YAM)) and low BMD (BMD 1 SD or more below YAM) in at least one of LS and TH were calculated to be 4.4% and 41.8%, respectively. The proportion of men with low BMD only at TH showed a significant increasing trend with aging (p < 0.0001) while that only at LS showed a decreasing trend (p = 0.0386). The prevalence rate of osteoporosis was underestimated when diagnosed using only BMD at LS. Other baseline measurements were successfully obtained.
Discussion
FORMEN baseline study was performed as designed and the FORMEN cohort study was successfully launched.
doi:10.1186/1471-2474-10-165
PMCID: PMC2811107  PMID: 20030855
23.  Evaluation of a novel nanocrystalline hydroxyapatite paste Ostim® in comparison to Alpha-BSM® - more bone ingrowth inside the implanted material with Ostim® compared to Alpha BSM® 
Background
The purpose of this study was to evaluate the performance a newly developed nanocrystalline hydroxyapatite, OSTIM® following functional implantation in femoral sites in thirty-eight sheep for 1, 2 or 3 months. Ostim® 35 was compared to an established calcium phosphate, Alpha BSM®.
Methods
Biomechanical testing, μ-CT analysis, histological and histomorphological analyses were conducted to compare the treatments including evaluation of bone regeneration level, material degradation, implant biomechanical characteristics.
Results
The micro-computed tomography (μCT) analysis and macroscopic observations showed that Ostim® seemed to diffuse easily particularly when the defects were created in a cancellous bone area. Alpha BSM® remained in the defect.
The performance of Ostim was good in terms of mechanical properties that were similar to Alpha BSM® and the histological analysis showed that the bone regeneration was better with Ostim® than with Alpha BSM®. The histomorphometric analysis confirmed the qualitative analysis and showed more bone ingrowth inside the implanted material with Ostim® when compared to Alpha BSM ® at all time points.
Conclusions
The successful bone healing with osseous consolidation verifies the importance of the nanocrystalline hydroxyapatite in the treatment of metaphyseal osseous volume defects in the metaphyseal spongiosa.
doi:10.1186/1471-2474-10-164
PMCID: PMC2807853  PMID: 20028538
24.  A modified QuickDASH-9 provides a valid outcome instrument for upper limb function 
Background
The 30-item Disabilities Arm Shoulder and Hand (DASH) questionnaire was introduced to facilitate assessment of upper limb functional limitations. To improve practicality and eliminate item redundancy a modified instrument was needed. The 11-item QuickDASH was developed to fulfil these requirements and translated into several languages. However, prospective investigations of psychometric and practical characteristics are limited. No published study investigated readability or used concurrent validation with a standardized upper limb criterion measure. The validity of the QuickDASH has been questioned as the results for factor structure are conflicting, and the English-language version has not yet had factor structure reported. A shortened 9-item version, the QuickDASH-9, that addresses these issues is proposed.
Methods
This two-stage observational study assessed the psychometric and practical characteristics of the QuickDASH and the extracted QuickDASH-9. The Upper Limb Functional Index (ULFI) was the criterion standard in both stages. Stage 1, calibration, reanalyzed extracted QuickDASH and QuickDASH-9 responses from a previous prospective study, by the authors, of the 30-item DASH (n = 137). Stage 2, prospective validation, investigated the QuickDASH through repeated measures in consecutive upper limb musculoskeletal participants' consulting for physical therapy in Australia (n = 67). The QuickDASH and extracted QuickDASH-9 data from both stages was analyzed and compared for psychometric properties, practical characteristics and factor structure.
Results
The proposed QuickDASH-9 had a unidimensional structure, high reliability (ICC 2:1, r = 0.92), internal consistency (alpha = 0.93) and responsiveness (ES = 1.05). It correlated highly with both the DASH (r = 0.97), QuickDASH (r = 0.99) and ULFI criterion (r = 0.85). QuickDASH-9 missing responses reduced to 3.5% from 26% in the QuickDASH. Completion and scoring time was 134 ± 56 seconds and required a computational aid. The QuickDASH demonstrated a bidimensional structure making it invalid. The QuickDASH-9 summary performance was measured on the 'Measurement of Outcome Measures' at 88% and on the 'Bot' clinimetric scale at 75%.
Conclusions
The proposed QuickDASH-9 had a unidimensional structure and similar psychometric precision to the full-length DASH with improved practicality and completion time. The QuickDASH was invalid as its bidimensional structure made a single summated score inappropriate. The QuickDASH-9 offers a future direction for ongoing use of the QuickDASH concept.
doi:10.1186/1471-2474-10-161
PMCID: PMC2810294  PMID: 20021677
25.  Dry needling and exercise for chronic whiplash - a randomised controlled trial 
Background
Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash.
Method/Design
A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1) dry-needling, advice and exercise or 2) sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI) and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted.
Discussion
This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash.
Trial registration
ACTRN12609000470291
doi:10.1186/1471-2474-10-160
PMCID: PMC2805606  PMID: 20021675

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