Exercise-induced pain changes associate with changes in muscle perfusion in knee osteoarthritis: exploratory outcome analyses of a randomised controlled trial.

BACKGROUND: Exercise therapy is recommended for knee osteoarthritis (OA), but the underlying mechanisms of pain relief are not fully understood. The purpose of this study was to explore the effects of exercise on muscle perfusion assessed by dynamic contrast enhanced MRI (DCE-MRI) and its association with changes in pain in patients with knee OA. METHODS: Exploratory outcome analyses of a randomised controlled study with per-protocol analyses ( ClinicalTrials.gov : NCT01545258) performed at an outpatient clinic at a public hospital in Denmark. We compared 12 weeks of supervised exercise therapy 3 times per week (ET) with a no attention control group (CG). Analyses of covariance (ANCOVA) were used to assess group mean differences in changes from baseline to week 12 in knee muscle perfusion quantified by DCE-MRI, patient-reported pain and function using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, knee extensor and flexor muscle strength tests, and the six-minute walking test (6MWT). Spearman's correlation coefficients were used to determine the correlation between changes in DCE-MRI variables, KOOS, muscle strength, and 6MWT. The potential effect mediation of the DCE-MRI perfusion variables was investigated in a post-hoc mediation analysis. RESULTS: Of 60 participants randomised with knee osteoarthritis, 33 (ET, n = 16, CG, n = 17) adhered to the protocol and had complete DCE-MRI data. At follow-up, there were significant group differences in muscle perfusion changes and clinically relevant group differences in KOOS pain changes (10.7, 95% CI 3.3 to 18.1, P = 0.006) in favor of ET. There were no significant between-group differences on muscle strength and function. The changes in pain and muscle perfusion were significantly correlated (highest Spearman's rho = 0.42, P = 0.014). The mediation analyses were generally not statistically significant. CONCLUSION: The pain-reducing effects of a 12-week exercise program are associated with changes in knee muscle perfusion quantified by DCE-MRI in individuals with knee OA, but whether the effects are mediated by muscle perfusion changes remains unclear. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01545258 , first posted March 6, 2012.

Dynamic weight-bearing assessment of pain in knee osteoarthritis: construct validity, responsiveness, and interpretability in a research setting.

BACKGROUND: The Osteoarthritis Research Society International (OARSI) has suggested to asses pain after specific activities consistently in clinical trials on knee OA. The Dynamic weight-bearing Assessment of Pain (DAP) assesses pain during activity (30 s of performing repeated deep knee-bends from a standing position). The purpose of this study is to evaluate the construct validity, responsiveness, and interpretability of the DAP for knee osteoarthritis (OA). METHODS: One-hundred participants with knee OA were tested twice each with the DAP, the Knee injury and Osteoarthritis Outcome Score (KOOS), six-minute-walk-test (6MWT), and 6-min-walk-test with subsequent pain rating (6MWTpain), and once with a transition questionnaire (TRANS-Q) for the patient-reported change in pain after 12 weeks of exercise. Construct validity (baseline-scores) and responsiveness (change-scores) were estimated by Spearman Correlation Coefficients. We hypothesized that no correlations would be excellent (<0.7) (divergent validity), except for the 6MWTpain (convergent validity). The TRANS-Q was used for interpreting the DAP change-scores in terms of responsiveness and Minimal Important Change (MIC). RESULTS: Divergent validity with the KOOS subscales (r = -0.31 to-0.45) and the 6MWT (r = -0.25) was supported. Convergent validity with the 6MWTpain was not supported (r = 0.54). The DAP change-scores corresponded to patient-reported change in pain (TRANS-Q), while correlations with change-scores on the other instruments were <0.35. The MIC was 2.4 DAP points. CONCLUSIONS: The DAP possesses divergent validity compared to other instruments for knee OA, supporting the potential for this new way of assessing pain directly during activity. Importantly, the DAP change-scores correspond to patient-reported changes in pain, showing responsiveness. A change of 2.4 or more can be interpreted as clinically relevant. The DAP is a promising alternative to using 'pain on walking' as a clinical trial inclusion criterion/outcome.

Treatment of adult patients with schizophrenia and complex mental health needs - A national clinical guideline.

BACKGROUND AND AIM: The Danish Health and Medicines Authority assembled a group of experts to develop a national clinical guideline for patients with schizophrenia and complex mental health needs. Within this context, ten explicit review questions were formulated, covering several identified key issues. METHODS: Systematic literature searches were performed stepwise for each review question to identify relevant guidelines, systematic reviews/meta-analyses, and randomized controlled trials. The quality of the body of evidence for each review question was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Clinical recommendations were developed on the basis of the evidence, assessment of the risk-benefit ratio, and perceived patient preferences. RESULTS: Based on the identified evidence, a guideline development group (GDG) recommended that the following interventions should be offered routinely: antipsychotic maintenance therapy, family intervention and assertive community treatment. The following interventions should be considered: long-acting injectable antipsychotics, neurocognitive training, social cognitive training, cognitive behavioural therapy for persistent positive and/or negative symptoms, and the combination of cognitive behavioural therapy and motivational interviewing for cannabis and/or central stimulant abuse. SSRI or SNRI add-on treatment for persistent negative symptoms should be used only cautiously. Where no evidence was available, the GDG agreed on a good practice recommendation. CONCLUSIONS: The implementation of this guideline in daily clinical practice can facilitate good treatment outcomes within the population of patients with schizophrenia and complex mental health needs. The guideline does not cover all available interventions and should be used in conjunction with other relevant guidelines.

Dynamic weight-bearing assessment of pain in knee osteoarthritis: a reliability and agreement study.

PURPOSE: To evaluate the reliability, agreement and smallest detectable change in a measurement instrument for pain and function in knee osteoarthritis; the Dynamic weight-bearing Assessment of Pain (DAP). METHODS: The sample size was set to 20 persons, recruited from the outpatient osteoarthritis clinic at Frederiksberg Hospital, Copenhagen. Two physiotherapists tested all participants during two visits; at the first visit, one single DAP (including four scores) was conducted by rater one; at the second visit, DAP was conducted by both raters one and two in randomized order with concealed allocation. The time interval was approximately 1.5 h. Measurement error was estimated by standard error of measurement (SEM). The intra- and inter-rater reliability was estimated by Intra-class Correlation Coefficients for agreement based on a two-way ANOVA with random effects (single measures ICC 2.1). Smallest detectable change (SDC) and limits of agreement were calculated. RESULTS: The pain score showed excellent reliability in terms of ICC (intra-rater 0.93, CI 0.83-0.97, inter-rater 0.91, CI 0.78-0.96), low SEM (intra-rater 0.70, inter-rater 0.86, on a scale from 0 to 10), and acceptable SDC for intra-rater test (1.95). The three knee bend scores all had ICC above 0.50, showing fair-to-good reliability. None of the knee bend scores showed acceptable SEM and SDC. CONCLUSIONS: The reproducibility of the DAP pain score meets the demands for use in clinical practice and research. The total knee bend could be useful for motivational purpose in clinical use. Testing of other psychometric properties of the DAP is pending.

The concept of physical limitations in knee osteoarthritis: as viewed by patients and health professionals.

OBJECTIVE: To comprehensively identify components of the physical limitation concept in knee osteoarthritis (OA) and to rate the clinical importance of these using perspectives of both patients and health professionals. DESIGN: Concept mapping, a structured group process, was used to identify and organize data in focus groups (patients) and via a global web-based survey (professionals). Ideas were elicited through a nominal group technique and then organized using multidimensional scaling, cluster analysis, participant validation, rating of clinical importance, and thematic analyses to generate a conceptual model of physical limitations in knee OA. RESULTS: Fifteen Danish patients and 200 international professionals contributed to generating the conceptual model. Five clusters emerged: 'Limitations/physical deficits'; 'Everyday hurdles'; 'You're not the person you used to be'; 'Need to adjust way of living'; and 'External limitations,' each with sub-clusters. Patients generally found their limitations more important than the professionals did. CONCLUSION: Patients and professionals agreed largely on the physical limitation concept in knee OA. Some limitations of high importance to patients were lower rated by the professionals, highlighting the importance of including patients when conceptualizing patient outcomes. These data offer new knowledge to guide selection of clinically relevant outcomes and development of outcome measures in knee OA.

Feasibility of ABLE 1.0-a program aiming at enhancing the ability to perform activities of daily living in persons with chronic conditions.

BACKGROUND: The "A Better everyday LifE" (ABLE) intervention was developed to accommodate the need of a program addressing ability to perform activities of daily living (ADL) in persons with chronic conditions living at home. During intervention development, it is necessary to evaluate relevant aspects of the feasibility of a program. Thus, the aim was to evaluate the feasibility of content and delivery of ABLE version 1.0. METHODS: A one group pre- and post-test design was applied. Thirty persons with chronic conditions, two occupational therapists (OTs), and five occupational therapy students (OTSs) participated. ABLE 1.0 is an 8-week program consisting of ADL evaluation (session 1); goal setting and reasons for ADL problems (session 2); intervention (sessions 3-7); and re-evaluation (final session), conducted in the clients' home-setting and local area. Sessions 1-4 and the final session was mandatory. To evaluate the feasibility of content and delivery, the OTs, after each session, reported on applied intervention component(s), time-use, needed equipment, adjustments, meaningfulness, confidence, progress toward goal attainment, and side effects using registration forms. The clients reported on progress toward goal attainment, meaningfulness, and satisfaction. Clinically relevant improvements in ADL ability were identified using the ADL-Interview (ADL-I) and the Assessment of Motor and Process Skills (AMPS). Goal attainment was evaluated using the Goal Attainment Scaling (GAS). RESULTS: Twenty clients (67%) completed ABLE 1.0 and received four sessions (median = 4, range 4-7) each lasting between 30 and 94 min. Most frequently applied component was "Changing habits related to task performance". Generally, OTs reported having the needed equipment. Deviations from the manual were made by omission of GAS and AMPS and less than mandatory number of sessions per client. The OTs reported confidence in delivering the program and the clients perceived the program as meaningful and satisfying, and experienced progress toward goal attainment. Goal attainment was found in 52% of the goals. Sixteen (80%) clients obtained clinically relevant improvements in self-reported or observed ADL ability. CONCLUSIONS: The content and delivery of ABLE 1.0 was feasible. However, the study revealed a need to adjust the recruitment procedure and make minor changes in the intervention manual. A pilot randomized controlled trial (RCT) study is recommended. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with registration no. NCT03335709 on November 8, 2017.

Identifying values and preferences around the choice of analgesia for patients with acute trauma pain in emergency and prehospital settings: using group concept mapping methodology.

OBJECTIVES: The main study aim was to examine the applicability of a novel method to assess the criterion of values and preferences within the Grading of Recommendation, Assessment, Development and Evaluation evidence to decision framework. The group concept mapping (GCM) approach was applied to identify, organise and prioritise values and preferences in the example of health professionals' choice of analgesia for patients with acute trauma pain. SETTING: Prehospital and emergency care centres in the Nordic countries of Denmark, Norway, Sweden, Finland and Iceland. PARTICIPANTS: Acute care health professionals with qualifications to administer analgesic agents to patients in emergency and prehospital settings, including advanced ambulance assistants, rescue officers, paramedics, emergency physicians and emergency nurses, participated in an online survey in which statements were generated (n=40) and structured (n=11) and finally analysed and interpreted in a validation meeting (n=4). RESULTS: Using GCM, ideas were generated and structured through online participation. Results were interpreted at a validation meeting. In total, 111 unique ideas were identified and organised into seven clusters: drug profile, administration, context, health professionals' preferences and logistics, safety profile, patient's medical history and acute clinical situation. CONCLUSIONS: Based on GCM, a conceptual model was developed, and values and preferences around choice of analgesia in emergency care were revealed. Health professionals within acute care can apply the conceptual model to support their decision-making when choosing the best available treatment for pain for their patients in emergency care.

Identifying, organizing and prioritizing ideas on how to enhance ADL ability.

BACKGROUND: There is a need to develop evidence-based occupational therapy programs aiming at enhancing the ability to perform Activities of Daily Living (ADL) among persons living with chronic conditions. Information from different sources is to be integrated in the development process. Thus, it is necessary to engage both occupational therapists and persons living with chronic conditions in suggesting ideas on how to enhance the ADL ability. OBJECTIVE: To identify, organize and prioritize ideas on how to enhance ability to perform ADL in persons with chronic conditions. MATERIAL AND METHOD: Group Concept Mapping, involving brainstorming, sorting, labeling, rating and validation of ideas, was applied among persons with chronic conditions (n = ≤ 18) and occupational therapists (n = ≤ 23). Multidimensional scaling analysis and cluster analyzes were applied. RESULTS: 149 ideas were identified and organized into seven clusters related to applying new adaptational strategies, personal factors, social surroundings and relevant services and opportunities. Each cluster contained ideas of high priority to persons with chronic conditions and/or occupational therapists. CONCLUSION: A span of highly relevant themes, illustrated the complexity of enhancing ADL ability. This should be considered in the development of interventions aiming at enhancing ADL ability in persons with chronic conditions.

Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology. METHODS: Systematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes. RESULTS: From 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach. CONCLUSION: The ideal way to assess harm aspects from the patients' perspective has not yet been ascertained.

Evaluation of an intervention programme addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a feasibility trial (ABLE).

INTRODUCTION: The number of persons living with a chronic condition is increasing worldwide. Conditions are considered chronic when lasting 1 year or more and requiring ongoing medical attention and/or limiting activities of daily living (ADL). Besides medical treatment, physical exercise to improve body functions is recommended and prescribed. However, improvements in body functions do not necessarily improve ability to perform ADL. Thus, it is necessary to develop interventions aiming directly at enhancing ADL ability. As a part of the research programme 'A Better Everyday Life', the first version of the ABLE intervention programme was developed. METHODS AND ANALYSIS: This feasibility study examine the perceived value and acceptability of the ABLE programme by evaluating the fidelity, reach, dose and potential outcomes using a pretest and post-test design involving 30 persons living with chronic conditions. Qualitative interviews among occupational therapists delivering and participants receiving the ABLE programme will be conducted to explore aspects affecting the intervention. ETHICS AND DISSEMINATION: The results will form the base for refinement of the ABLE programme and planning of a large-scale randomised controlled trial investigating the effect of the programme on self-reported and observed ADL ability. Dissemination will include peer-reviewed publications and presentations at national and international conferences. PROTOCOL VERSION: 7 November 2017: v ersion 1.0. 19 February 2018: v ersion 2.0. TRIAL REGISTRATION NUMBER: NCT03335709; Pre-results.

The Parker Model: Applying a Qualitative Three-Step Approach to Optimally Utilize Input from Stakeholders When Introducing New Device Technologies in the Management of Chronic Rheumatic Diseases.

BACKGROUND AND OBJECTIVE: Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lack generalizability. This study aimed to assess the face validity and feasibility of using a composite, three-step qualitative method (the Parker Model), to inform the development and implementation of ava®, an electromechanical device (e-Device) for subcutaneous self-administration of the biologic, certolizumab pegol (CZP), used to treat rheumatic diseases. METHODS: The Parker Model combines concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE). CM, a structured group process, was used to identify patients' opinions and concerns regarding the e-Device. Patients used this information in iterative PD sessions to create personal e-Device prototypes in cooperation with a designer and a healthcare professional. SE was performed based on semi-structured group and individual interviews with patients and disease-management stakeholders. RESULTS: The study recruited 14 patients, two doctors, two nurses, one medical secretary, and four other public servants. Three CM workshops revealed four key considerations: technical usability, physical design, concerns, and enthusiasm. Four personalized prototypes were developed during PD sessions. SE confirmed that the identified considerations were pivotal for the implementation and adaptation of the e-Device. CONCLUSIONS: This study is the first to apply a composite, qualitative research model when introducing an e-Device for the treatment and management of rheumatic disease. Results show that input from patients and other stakeholders using the Parker Model can add value to the development and implementation of an e-Device.

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

BACKGROUND: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. OBJECTIVES: To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. METHODS: A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. RESULTS: Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. CONCLUSIONS: At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS.

The risk associated with spinal manipulation: an overview of reviews.

BACKGROUND: Spinal manipulative therapy (SMT) is a widely used manual treatment, but many reviews exist with conflicting conclusions about the safety of SMT. We performed an overview of reviews to elucidate and quantify the risk of serious adverse events (SAEs) associated with SMT. METHODS: We searched five electronic databases from inception to December 8, 2015. We included reviews on any type of studies, patients, and SMT technique. Our primary outcome was SAEs. Quality of the included reviews was assessed using a measurement tool to assess systematic reviews (AMSTAR). Since there were insufficient data for calculating incidence rates of SAEs, we used an alternative approach; the conclusions regarding safety of SMT were extracted for each review, and the communicated opinion were judged by two reviewers independently as safe, harmful, or neutral/unclear. Risk ratios (RRs) of a review communicating that SMT is safe and meeting the requirements for each AMSTAR item, were calculated. RESULTS: We identified 283 eligible reviews, but only 118 provided data for synthesis. The most frequently described adverse events (AEs) were stroke, headache, and vertebral artery dissection. Fifty-four reviews (46%) expressed that SMT is safe, 15 (13%) expressed that SMT is harmful, and 49 reviews (42%) were neutral or unclear. Thirteen reviews reported incidence estimates for SAEs, roughly ranging from 1 in 20,000 to 1 in 250,000,000 manipulations. Low methodological quality was present, with a median of 4 of 11 AMSTAR items met (interquartile range, 3 to 6). Reviews meeting the requirements for each of the AMSTAR items (i.e. good internal validity) had a higher chance of expressing that SMT is safe. CONCLUSIONS: It is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015030068 .

Critical Outcomes in Longitudinal Observational Studies and Registries in Patients with Rheumatoid Arthritis: An OMERACT Special Interest Group Report.

OBJECTIVE: Outcomes important to patients are those that are relevant to their well-being, including quality of life, morbid endpoints, and death. These outcomes often occur over the longterm and can be identified in prospective longitudinal observational studies (PLOS). There are no standards for which outcome domains should be considered. Our overarching goal is to identify critical longterm outcome domains for patients with rheumatic diseases, and to develop a conceptual framework to measure and classify them within the scope of OMERACT Filter 2.0. METHODS: The steps of this initiative primarily concern rheumatoid arthritis (RA) and include (1) performing a systematic review of RA patient registries and cohorts to identify previously collected and reported outcome domains and measurement instruments; (2) developing a conceptual framework and taxonomy for identification and classification of outcome domains; (3) conducting focus groups to identify domains considered critical by patients with RA; and (4) surveying patients, providers, and researchers to identify critical outcomes that can be evaluated through the OMERACT filter. RESULTS: In our initial evaluation of databases and registries across countries, we found both commonalities and differences, with no clear standardization. At the initial group meeting, participants agreed that additional work is needed to identify which critical outcomes should be collected in PLOS, and suggested several: death, independence, and participation, among others. An operational strategy for the next 2 years was proposed. CONCLUSION: Participants endorsed the need for an initiative to identify and evaluate critical outcome domains and measurement instruments for data collection in PLOS.

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. RESULTS: Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations.

Study Design Secondary analysis of clinical trial data. Background Knee osteoarthritis (OA) management has changed significantly over recent decades toward nonpharmacological treatments, particularly exercise. However, the optimal exercise program remains to be established. Objective To describe the implementation of standardized rescue exercises for patients with pain exacerbations and to assess whether performing these benefit or further worsen symptoms in patients with exacerbated symptoms of knee OA. Methods The data from 2 randomized controlled studies of exercise in patients with knee OA were used. A supervised, standard exercise program that included standardized "rescue" exercises to be performed in the event of symptomatic exacerbation, defined as knee pain of greater than 5 on a 0-to-10 numeric pain-rating scale, was conducted for 12 weeks at 3 sessions per week. Pain ratings were obtained before and after each exercise session. Results Of 131 participants included, 2 never commenced the exercise program, leaving 129 to be included in the analysis. The analysis was observational and thus had no comparison group. During the program, 36 participants (28%) were referred to the rescue exercises. In 63% of the rescue sessions, the participants experienced decreased pain intensity (average ± SD, -2.6 ± 2.3), 27% reported no change in pain, and 10% reported increased pain intensity (average ± SD, 1.3 ± 0.5). Conclusion Having a predefined and standardized rescue exercise option appears beneficial, and did not result in further worsening of exacerbated knee OA symptoms. The intervention may be particularly relevant for patients with knee OA who have more severe symptoms. Level of Evidence Therapy, level 2b. Registered at www.clinicaltrials.gov (NCT01545258 and NCT01945749). J Orthop Sports Phys Ther 2016;46(11):942-946. Epub 28 Sep 2016. doi:10.2519/jospt.2016.6908.

Comparable effects of exercise and analgesics for pain secondary to knee osteoarthritis: a meta-analysis of trials included in Cochrane systematic reviews.

AIM: Evidence of comparative effectiveness of different treatment approaches is important for clinical decision-making, yet absent for most recommended treatments of knee osteoarthritis pain. The objective of this study was to estimate the comparative effectiveness of exercise versus orally administered analgesics for pain in patients with knee osteoarthritis. METHODS: The Cochrane Database of systematic reviews was searched for meta-analyses of randomized controlled studies comparing exercise or analgesics with a control group (placebo or usual care) and with pain as an outcome. Individual study estimates were identified and effect sizes were calculated from group differences. We combined study-level effects on pain with a random effects meta-analysis and compared effect sizes between exercise trials and trials with analgesic interventions. RESULTS: We included six Cochrane reviews (four pharmacology, two exercise). From these, 54 trials were eligible (20 pharmacology, 34 exercise), with 9806 participants (5627 pharmacology, 4179 exercise). The pooled effect size of pharmacological pain interventions was 0.41 (95% CI: 0.23-0.59) and for exercise 0.46 standardized mean difference (95% CI: 0.34-0.59). There was no statistically significant difference between the two types of intervention (difference: 0.06 standardized mean difference [95% CI: -0.28-0.16; p = 0.61]). CONCLUSION: This meta-epidemiological study provides indirect evidence that for knee osteoarthritis pain, the effects from exercise and from oral analgesics are comparable. These results may support shared decision-making where a patient for some reason is unable to exercise or who consider exercise as unviable and analgesics as a more feasible choice. PROSPERO registration: CRD42013006924.

Intra-Articular Corticosteroids in Addition to Exercise for Reducing Pain Sensitivity in Knee Osteoarthritis: Exploratory Outcome from a Randomized Controlled Trial.

OBJECTIVE: To assess the effects of one intra-articular corticosteroid injection two weeks prior to an exercise-based intervention program for reducing pain sensitivity in patients with knee osteoarthritis (OA). DESIGN: Randomized, masked, parallel, placebo-controlled trial involving 100 participants with clinical and radiographic knee OA that were randomized to one intra-articular injection on the knee with either 1 ml of 40 mg/ml methylprednisolone (corticosteroid) dissolved in 4 ml lidocaine (10 mg/ml) or 1 ml isotonic saline (placebo) mixed with 4 ml lidocaine (10 mg/ml). Two weeks after the injections all participants undertook a 12-week supervised exercise program. Main outcomes were changes from baseline in pressure-pain sensitivity (pressure-pain threshold [PPT] and temporal summation [TS]) assessed using cuff pressure algometry on the calf. These were exploratory outcomes from a randomized controlled trial. RESULTS: A total of 100 patients were randomized to receive either corticosteroid (n = 50) or placebo (n = 50); 45 and 44, respectively, completed the trial. Four participants had missing values for PPT and one for TS at baseline; thus modified intention-to-treat populations were analyzed. The mean group difference in changes from baseline at week 14 was 0.6 kPa (95% CI: -1.7 to 2.8; P = 0.626) for PPT and 384 mm×sec (95% CI: -2980 to 3750; P = 0.821) for TS. CONCLUSIONS: These results suggest that adding intra-articular corticosteroid injection 2 weeks prior to an exercise program does not provide additional benefits compared to placebo in reducing pain sensitivity in patients with knee OA. TRIAL REGISTRATION: EU clinical trials (EudraCT): 2012-002607-18.

No effects of functional exercise therapy on walking biomechanics in patients with knee osteoarthritis: exploratory outcome analyses from a randomised trial.

AIM: To assess the effects of a functional and individualised exercise programme on gait biomechanics during walking in people with knee OA. METHODS: Sixty participants were randomised to 12 weeks of facility-based functional and individualised neuromuscular exercise therapy (ET), 3 sessions per week supervised by trained physical therapists, or a no attention control group (CG). Three-dimensional gait analyses were used, from which a comprehensive list of conventional gait variables were extracted (totally 52 kinematic, kinetic and spatiotemporal variables). According to the protocol, the analyses were based on the 'Per-Protocol' population (defined as participants following the protocol with complete and valid gait analyses). Analysis of covariance adjusting for the level at baseline was used to determine differences between groups (95% CIs) in the changes from baseline at follow-up. RESULTS: The per-protocol population included 46 participants (24 ET/22 CG). There were no group differences in the analysed gait variables, except for a significant group difference in the second peak knee flexor moment and second peak vertical ground reaction force. CONCLUSION: While plausible we have limited confidence in the findings due to multiple statistical tests and lack of biomechanical logics. Therefore we conclude that a 12-week supervised individualised neuromuscular exercise programme has no effects on gait biomechanics. Future studies should focus on exercise programmes specifically designed to alter gait patterns, or include other measures of mobility, such as walking on stairs or inclined surfaces. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01545258.

Hand-related physical function in rheumatic hand conditions: a protocol for developing a patient-reported outcome measurement instrument.

INTRODUCTION: There is no consensus about what constitutes the most appropriate patient-reported outcome measurement (PROM) instrument for measuring physical function in patients with rheumatic hand conditions. Existing instruments lack psychometric testing and vary in feasibility and their psychometric qualities. We aim to develop a PROM instrument to assess hand-related physical function in rheumatic hand conditions. METHODS AND ANALYSIS: We will perform a systematic search to identify existing PROMs to rheumatic hand conditions, and select items relevant for hand-related physical function as well as those items from the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank that are relevant to patients with rheumatic hand conditions. Selection will be based on consensus among reviewers. Content validity of selected items will be established through the use of focus groups. If patients deem necessary, we will develop new items based on the patients' input. We will examine whether it is valid to score all selected and developed items on the same scale as the original items from the PROMIS PF item bank. Our analyses will follow the methods used for calibrating the original PROMIS PF item bank in US samples, which were largely based on the general PROMIS approach. ETHICS AND DISSEMINATION: This study will be carried out in accordance with the Helsinki Declaration. Ethics approvals will be obtained where necessary, and signed informed consent will be obtained from all participants. We aim to disseminate the results of the study through publication in international peer-reviewed journals and at international conferences.