Physiotherapy for pain: a meta-epidemiological study of randomised trials.

OBJECTIVES: To empirically assess the clinical effects of physiotherapy on pain in adults. DESIGN: Using meta-epidemiology, we report on the effects of a 'physiotherapy' intervention on self-reported pain in adults. For each trial, the group difference in the outcome 'pain intensity' was assessed as standardised mean differences (SMD) with 95% CIs. Stratified analyses were conducted according to patient population (International Classification of Diseases-10 classes), type of physiotherapy intervention, their interaction, as well as type of comparator group and risks of bias. The quality of the body of evidence was assessed based on GRADE methodology. DATA SOURCES: Systematic searches were carried out in MEDLINE and PEDro from 1 January 2004-31 December 2013. 174 trials (224 comparisons) met the inclusion criteria for the meta-analysis. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised trials using 'no intervention' or of a sham-controlled design were selected. Only articles written in English were eligible. RESULTS: An overall moderate effect of physiotherapy on pain corresponding to 0.65 SD-units (95% CI 0.57 to 0.73) was found based on a moderate inconsistency (I(2)=51%). Stratified exploration showed that therapeutic exercise for musculoskeletal diseases tended to be more beneficial than multimodal interventions (difference 0.30 95% CI 0.03 to 0.57; p=0.03). Trials with a 'no intervention' comparator tended to have a higher overall effect size than trials with a sham comparator (difference 0.25; 95% CI 0.09 to 0.41; p=0.004). In general, our confidence in the estimates was low, mainly due to high risk of performance biases and between-study heterogeneity. CONCLUSIONS: Physiotherapy reduces pain in adults, but standardisation of interventions and focus on trial research with low risks of bias and reproducible treatment modalities are needed. TRIAL REGISTRATION NUMBER: CRD42014008754.

Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle Stretching in a Nonpainful Population: A Randomized Trial.

BACKGROUND: Stretching is often used in clinical practice for a variety of purposes, including pain therapy. The possible mechanism behind the effect of stretching remains to be clarified. AIM: To investigate whether 4 weeks of unilateral stretching of the calf muscles would affect local and central pain sensitivity. METHOD: This study was a randomized assessor-blinded clinical study. Healthy participants (age 18 to 40) were included and randomized. Participants in the intervention group were instructed to perform 2 stretching exercises targeting the calf muscles; 3 times 30 seconds, 7 days a week for 4 weeks on the dominant leg. Participants in the control group were instructed not to do any stretching for 4 weeks. Pressure pain threshold (PPT) and temporal summation (TS) of pressure pain were measured on the stretched calf, the contra-lateral calf, and contra-lateral lower arm using a computerized cuff algometer. Analyses of variance on the per-protocol population (defined as participants that adhered to the protocol) were used to assess group differences in the changes from baseline. RESULT: Forty healthy volunteers were included, of which 34 participants adhered to the protocol (15 intervention group/19 control group). No statistically significant group differences in the changes from baseline were found regarding PPT and TS measurements for the stretched calf, the contra-lateral calf, and the arm. CONCLUSION: Four weeks of regular stretching of the calf muscles does not affect pressure pain sensitivity, suggesting that pressure pain sensitivity is unaffected by stretching in a healthy population. The mechanisms underlying any benefits of regular stretching remain to be explained.

Effect of research participation versus usual clinical care in patients with rheumatic and musculoskeletal disorders: a prospective cohort study.

OBJECTIVE: To compare illness perception (IP), pain, functional level and health-related quality of life (HR-QoL) between patients with musculoskeletal pain who participate versus those who do not participate in clinical research projects. METHODS: Data were collected between 1 January 2019 and 31 December 2021 in patients visiting the Outpatient Osteoarthritis Clinic at Frederiksberg Hospital, Copenhagen, as part of either clinical research or regular treatment. Questionnaires were collected at baseline and after 10-18 months. Major outcome measure was the change from baseline to follow-up in the Brief Pain Inventory - Short Form (BPI-SF) item 'Average pain'. Secondary outcome measures included The Brief Illness Perception Questionnaire (B-IPQ), measured only at baseline, the EuroQol (EQ-5D-3L), the Health Assessment Questionnaire Disability Index and PainDETECT. RESULTS: 1495 patients were included with 358 (24%) categorised as research participants (exposed) and 1137 (76%) being non-participants (unexposed). The baseline B-IPQ item scores were generally more favourable in the exposed group with statistically significant standardised differences (SD) of 0.2-0.3. Similarly, an SD of 0.3 on the EQ-5D-3L score indicated a better HR-QoL in the exposed group. At follow-up, 24% in the exposed group and 27% in the unexposed group, completed the questionnaires. The mean BPI-sf Average pain between-group difference was: -0.01 points (95% CI: -0.6 to 0.6). Similar clinically irrelevant differences were seen in the other outcomes. CONCLUSIONS: Among musculoskeletal pain patients, research participants report more positive IP and better HR-QoL than non-participants. No additional effect of research participation was found in any outcome over time. TRIAL REGISTRATION NUMBER: NCT03785561.

Prognostic value of illness perception on changes in knee pain among elderly individuals: Two-year results from the Frederiksberg Cohort study.

Objective: To investigate the prognostic value of illness perception (IP) on knee pain, quality of life (QoL) and functional level in elderly individuals reporting knee pain. Design: A prospective cohort study of 1552 elderly with knee pain comparing two previously established clusters based on the Brief Illness Perception questionnaire. Cluster 1 ("Concerned optimists" [hypothesized unfavorable profile]; n â€‹= â€‹642) perceived their knee pain as a greater threat to them than Cluster 2 ("Unconcerned confident" [hypothesized favorable profile]; n â€‹= â€‹910). Primary outcome was the change from baseline to year 2 in the KOOS Pain subscale. Secondary outcomes were changes from baseline in quality of life (EuroQol-5 Domain and EQ VAS) and in the KOOS subscales Symptom, Activities of Daily Living, Knee-related QoL and Sports and recreation. Analyses were done on the original Intention-To-Survey (ITS) population, using repeated measures mixed linear models. Results: Among the ITS population, 841 (54%) responded to the 2-year survey. There was a statistically significant but clinically irrelevant cluster difference in the 2-year change from baseline in KOOS pain (mean difference: 6.0 KOOS points [95% CI: 7.3 to -4.7]) explained by a minor improvement in Cluster 1: (6.2 points) and no changes in Cluster 2: (0.2 points). Comparable results were found across the secondary outcomes. Clinically irrelevant cluster changes in IP were seen. Conclusion: In a cohort of people with knee pain, IP phenotype (i.e., Clusters) were of no prognostic value for the 2-year changes in pain, function, and QoL. Targeting IP may not be relevant in this patient population. Trial registration number and date of registration: The Frederiksberg Cohort study was pre-registered at clinicaltrials.gov (NCT03472300) on March 21, 2018.

What should a toolkit to aid the delivery of therapeutic exercise for hip and knee osteoarthritis look like? Qualitative analysis of an international survey of 318 researchers, clinicians, and consumers by the OARSI Rehabilitation Discussion Group.

BACKGROUND: We aimed to identify important components of, and practical resources relevant for inclusion in, a toolkit to aid exercise delivery for people with hip/knee osteoarthritis. METHOD: An online international multi-disciplinary survey was conducted across 43 countries (139 clinicians, 44 people with hip/knee osteoarthritis and 135 osteoarthritis researchers). Participants were presented with the seeding statement 'Practical resources to aid the implementation of exercise for people with hip/knee osteoarthritis should…' and asked to provide up to 10 open text responses. Responses underwent refinement and qualitative content analysis to create domains and categories. RESULTS: Refinement of 551 open text responses yielded 72 unique statements relevant for analysis. Statements were organised into nine broad domains, suggesting that resources to aid exercise delivery should: (1) be easily accessible; (2) be of high quality; (3) be developed by, and for, stakeholders; (4) include different ways of delivering information; (5) include different types of resources to support exercise and non-exercise components of self-management; (6) include resources on recommended exercises and how to perform/progress them; (7) include tools to support motivation and track progress; (8) include resources to enable tailoring of the programme to the individual and; (9) facilitate access to professional and peer support. CONCLUSION: Our findings identified important components of, and practical resources to include within, a toolkit to aid delivery of exercise for people with hip/knee osteoarthritis. These findings have implications for exercise providers and lay the foundation for the development of a toolkit to help ensure exercise provision aligns with current international recommendations.

Colchicine twice a day for hand osteoarthritis (COLOR): a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Colchicine has been suggested for osteoarthritis treatment, but evidence is contradictory. We aimed to investigate colchicine's efficacy and safety compared with placebo in people with hand osteoarthritis. METHODS: In this single-centre, double-blind, randomised, placebo-controlled trial we recruited adults with symptomatic hand osteoarthritis and finger pain of at least 40 mm on a 100 mm visual analogue scale from an outpatient clinic in Denmark. The hand with the most severe finger pain at inclusion was the target hand. Participants were randomly assigned (1:1) to 0·5 mg colchicine or placebo taken orally twice a day for 12 weeks, stratified by BMI (≥30 kg/m2), sex, and age (≥75 years). Participants, outcome assessors, and data analysts were masked to treatment allocation. The primary endpoint was change from baseline to week 12 in target hand finger pain, assessed on a 100 mm visual analogue scale with a pre-specified minimal clinically important difference of 15 mm, in the intention-to-treat population. Safety was assessed at week 12 in the intention-to-treat population. The study was registered with ClinicalTrials.gov, NCT04601883, and with EudraCT, 2020-002803-20. FINDINGS: Between Jan 15, 2021, and March 3, 2022, 186 people were screened for eligibility, and 100 were randomly assigned to receive colchicine (n=50) or placebo (n=50). Participants had a mean age of 70·9 (SD 7·5) years, 69 (69%) of 100 were women and 31 (31%) were men. All participants completed the study. The mean change from baseline to week 12 in finger pain were -13·9 mm (SE 2·8) in the colchicine group and -13·5 mm (2·8) in the placebo group, with a between-group difference (colchicine vs placebo) of -0·4 mm (95% CI -7·6 to 6·7; p=0·90). In the colchicine group, there were 76 adverse events in 36 (72%) of 50 participants and one serious adverse advent (migraine attack leading to hospital admission). In the placebo group, there were 42 adverse events in 22 (44%) of 50 participants and two serious adverse events (cholecystitis and elevated alanine aminotransferase concentrations, in the same patient). INTERPRETATION: In people with painful hand osteoarthritis, treatment with 0·5 mg of colchicine twice day for 12 weeks did not effectively relieve pain, and treatment with colchicine was associated with more adverse events. FUNDING: The Oak Foundation, IMK Almene Fond, Minister Erna Hamilton's Scholarship for Science and Art, AP Moller and Wife Chastine McKinney Moller's Foundation for Medical Science Advancement, The Danish Medical Association, the Velux Foundation, Aase and Ejnar Danielsen's Foundation, and Director Emil C Hertz and Wife Inger Hertz's foundation.

The correlation between illness perception, pain intensity and quality of life in elderly with low back pain in Denmark: a cross-sectional study.

Background: Illness perception is related to management patterns and pain intensity, but among elderly with low back pain, this relation is unclear. The aims of this study were to analyse the associations between illness perception, pain intensity and health related quality of life in a group of elderly with low back pain and explore how different illness perception profiles would cluster and differ in terms of pain, quality of life and choice of management. Method: This was a cross-sectional survey based on a cohort of originally 640 Danish children. Of the 311 respondents in 2019, 69% reported low back pain within last year and were included. Associations between illness perceptions (Brief illness perception questionnaire), health related quality of life (EuroQol-5 Domain-3L) and low back pain intensity were assessed, and participants were clustered based on their perceptions using hierarchical and K-means cluster analysis. Cluster differences in pain, quality of life and use of pharmacological and non-pharmacological treatments were explored. Results: Among the 213 individuals with low back pain, 33% reported severe or fluctuating pain intensity. Higher pain intensity was associated with perceiving low back pain as a greater threat. Participants reporting fluctuating pain perceived their low back pain almost as threatening as participants reporting severe pain. Two clusters were identified. Cluster 1 reported lower quality of life (difference in medians: -0.176 (95% CI [-0.233--0.119 ])) and was more likely to report severe or fluctuating pain (37.7% vs. 4.5% [P < 0.0001]) and to use pharmacological treatments than Cluster 2 (37.7% vs. 14.9% [P < 0.001]). No association was found between clusters concerning use of non-pharmacological treatments (P = 0.134). Conclusion: Based on illness perceptions, two clusters differing in pain intensity, quality of life and use of pharmacological treatments were identified. Targeting illness perceptions may be beneficial during rehabilitation or when guiding patients with low back pain in choice of management.

Estimating the Prevalence of Knee Pain and the Association between Illness Perception Profiles and Self-Management Strategies in the Frederiksberg Cohort of Elderly Individuals with Knee Pain: A Cross-Sectional Study.

Knee pain is an early sign of later incident radiographic knee osteoarthritis (OA). However, the prevalence of knee pain in the general population is unknown. Additionally, it is unknown how people with knee pain choose to self-manage the condition and if the perception of the illness affects these choices. In this study, 9086 citizens between 60-69 years old in the municipality of Frederiksberg, Copenhagen, Denmark, were surveyed, of which 4292 responded. The prevalence of knee pain was estimated, and associations between illness perceptions (brief illness perception questionnaire [B-IPQ]), self-management strategies, and knee symptoms were assessed. The prevalence of knee pain was 21.4% of which 40.5% reported to use no self-management strategies (non-users). These non-users perceived their knee pain as less threatening and reported less severe symptoms than users of self-management strategies. Further, we found that a more positive illness perception was associated with less severe knee symptoms. In conclusion, among Danes aged 60-69 years, the knee pain prevalence is 21.4%, of which 40.5% use no treatment and perceive the condition as non-threatening. These non-users with knee pain represent a subpopulation being at increased risk of developing knee OA later in life, and there is a potential preventive gain in identifying these persons.

Controversy and Debate on Meta-epidemiology. Paper 1: Treatment effect sizes vary in randomized trials depending on the type of outcome measure.

OBJECTIVE: To compare estimated treatment effects of physical therapy (PT) between patient-reported outcome measures (PROMs) and outcomes measured in other ways. STUDY DESIGN AND SETTING: We selected randomized trials of PT with both a PROM and a non-PROM included in Cochrane systematic reviews (CSRs). Two reviewers independently extracted data and risk-of-bias assessments. Our primary outcome was the ratio of odds ratios (RORs), used to quantify how effect varies between PROMs and non-PROMs; an ROR > 1 indicates larger effect when assessed by using PROMs. We used REML-methods to estimate associations of trial characteristics with effects and between-trial heterogeneity. RESULTS: From 90 relevant CSRs, 205 PT trials were included. The summary ROR across all the comparisons was not statistically significant (ROR, 0.88 [95% CI: 0.70-1.12]; P = 0.30); however, the heterogeneity was substantial (I2 = 88.1%). When stratifying non-PROMs further into clearly objective non-PROMs (e.g., biomarkers) and other non-PROMs (e.g., aerobic capacity), the PROMs appeared more favorable than did clearly objective non-PROMs (ROR, 1.92 [95% CI: 0.99-3.72]; P = 0.05). CONCLUSION: Estimated treatment effects based on PROMs are generally comparable with treatment effects measured in other ways. However, in our study, PROMs indicate a more favorable treatment effect compared with treatment effects based on clearly objective outcomes.

Prevalence of self-reported knee symptoms and management strategies among elderly individuals from Frederiksberg municipality: protocol for a prospective and pragmatic Danish cohort study.

INTRODUCTION: The Global Burden of Disease 2010 study ranked osteoarthritis (OA) as a leading cause of years lived with disability. With an ageing population, increasing body weight and sedentary lifestyle, a substantial increase especially in knee OA (KOA) is expected. Management strategies for KOA include non-pharmacological, pharmacological and surgical interventions. Meanwhile, over-the-counter pain medications have been discredited as they are associated with several risks with long-term usage. By consequence, the use of exercise and all sorts of complementary and alternative medicine (CAM) for joint pain has increased. The available self-management strategies are plenty, but there is no overview of their use at a population level and whether they are used along with doctors' prescriptions or replace these. The aim of this study is to estimate the population incidence of developing knee symptoms and analyse the association between (and impact of) the use of self-reported preventive measures and knee symptoms. METHODS AND ANALYSIS: This prospective cohort study pragmatically recruits individuals from the municipality of Frederiksberg, Denmark. All citizens aged 60-69 years old will be contacted annually for 10 years and asked to participate in a web-based survey. The major outcomes are self-reported knee symptoms and their association with use of various management strategies, including use of non-pharmacological treatments and CAM. Secondary outcomes include the influence of treatments on use of healthcare system and surgical procedures. Descriptive and analytic statistics (eg, logistic regression) will be used to provide summaries about the sample and observations made and the associations between self-management and development of knee symptoms. ETHICS AND DISSEMINATION: This study can be implemented without permission from the Health Research Ethics Committee. Permission has been obtained from the Danish Data Protection Agency. Study findings will be disseminated in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: NCT03472300.

Improved gait in persons with knee related mobility limitations by a rosehip food supplement: A randomized, double-blind, placebo-controlled trial.

PURPOSE: To evaluate the efficacy of a specialized rosehip powder nutraceutical on the biomechanical function of the knee joint during walking in individuals with knee-related walking limitations. METHODS: Randomized, participant and outcome assessor blinded trial. Participants with self-reported knee-related walking limitations were randomized (1:1) to receive three capsules/day of either rosehip powder or identically appearing placebo capsules for 12 weeks. At baseline and the 12 weeks follow-up, 3-dimensional gait analyses were performed from which the peak resultant knee moment was selected as primary outcome. Secondary outcomes included sagittal and frontal plane knee joint moments, knee joint kinematics, peaks in the vertical ground reaction forces, and self-selected walking speeds. Analyses were based on ANCOVA with the 'Intention-To-Treat' (ITT) population, defined as all randomized participants using last observation carried forward imputation for missing data. RESULTS: 100 participants were randomized to rosehip (n=50) or placebo (n=50) and defined the ITT population. Of these 94 completed the study (47 in each group). There were statistically significant group differences in the change from baseline in the primary outcome: the resultant knee moment (0.06 nm/kg, 95%CI: 0.00-0.12; P=0.039) and in the peaks in the sagittal plane moments and kinematics during the stance phase of walking with the rosehip group exhibiting greater joint moments and more knee joint flexion during walking than the placebo group. CONCLUSION: A daily intake of rosehip powder for 12 weeks improved important indices of knee joint function and dynamics during walking compared to placebo in persons with knee-related walking limitations.