P05.31. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis (original) (raw)

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis

Trials, 2012

Background: Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. Methods: The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. Results: The manualized protocol addressed identical specified body regions with distinct 30-and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30-and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. Conclusions: The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Trial registration: Clinicaltrials.gov NCT00970008 (

Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial

Journal of General Internal Medicine

BACKGROUND: Current treatment options for knee osteoarthritis have limited effectiveness and potentially adverse side effects. Massage may offer a safe and effective complement to the management of knee osteoarthritis. OBJECTIVE: Examine effects of whole-body massage on knee osteoarthritis, compared to active control (lighttouch) and usual care. DESIGN: Multisite RCT assessing the efficacy of massage compared to light-touch and usual care in adults with knee osteoarthritis, with assessments at baseline and weeks 8, 16, 24, 36, and 52. Subjects in massage or light-touch groups received eight weekly treatments, then were randomized to biweekly intervention or usual care to week 52. The original usual care group continued to week 24. Analysis was performed on an intention-to-treat basis. PARTICIPANTS: Five hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52week assessments. INTERVENTION: Sixty minutes of protocolized full-body massage or light-touch. MAIN MEASURES: Primary: Western Ontario and McMaster Universities Arthritis Index. Secondary: visual analog pain scale, PROMIS Pain Interference, knee range of motion, and timed 50-ft walk. KEY RESULTS: At 8 weeks, massage significantly improved WOMAC Global scores compared to light-touch (− 8.16, 95% CI = − 13.50 to − 2.81) and usual care (− 9.55, 95% CI = − 14.66 to − 4.45). Additionally, massage improved pain, stiffness, and physical function WOMAC subscale scores compared to light-touch (p < 0.001; p = 0.04; p = 0.02, respectively) and usual care (p < 0.001; p = 0.002; p = 0.002; respectively). At 52 weeks, the omnibus test of any group difference in the change in WOMAC Global from baseline to 52 weeks was not significant (p = 0.707, df = 3), indicating no significant difference in change across groups. Adverse events were minimal. CONCLUSIONS: Efficacy of symptom relief and safety of weekly massage make it an attractive short-term treatment option for knee osteoarthritis. Longer-term biweekly dose maintained improvement, but did not provide additional benefit beyond usual care post 8-week treatment. TRIAL REGISTRATION: clinicaltrials.gov NCT01537484

Manual therapy can be a potential therapy in knee osteoarthritis

Saudi Journal of Sports Medicine, 2018

Objective: Osteoarthritis (OA) is a disease of diversified etiology that causes the degeneration of the articular cartilage leading to proliferation of novel bone and reshaping of joint outline. A randomized controlled trial was conducted at the Department of Physiotherapy, Mayo Hospital, Lahore, to examine the effects of manual therapy training and neuromuscular training on knee OA. Materials and Methods: We conveniently selected a sample of 58 patients and placed into two groups. Manual therapy was applied in Group A and neuromuscular training in Group B along with conventional physiotherapy for 4 weeks. Results: The goniometry, visual analog scale, and Western Ontario and McMaster Osteoarthritis Index for knee OA were assessment tools to assess all the patients before and after 2 weeks of physical therapy intervention. Patients in Group A showed marked improvement as compared to Group B (P>0.05). Conclusion: The manual therapy group shows better results in improving pain and reducing physical disability. This study concluded that manual therapy had a more positive impact in improving pain, range of motion, and function as compared to those patients who were treated by neuromuscular training.

Manual therapy for osteoarthritis of the hip or knee – A systematic review

Manual Therapy, 2011

The aim of this systematic review was to determine if manual therapy improves pain and/or physical function in people with hip or knee OA. Eight databases were searched for randomised controlled trials (RCTs). Data were extracted and risk of bias assessed by independent reviewers. Four RCTs were eligible for inclusion (280 subjects), three of which studied people with knee OA and one studied those with hip OA. One study compared manual therapy to no treatment, one compared to placebo intervention, whilst two compared to alternative interventions. Meta-analysis was not possible due to clinical heterogeneity of the studies. One study had a low risk of bias and three had high risk of bias. All studies reported shortterm effects, and long-term effects were measured in one study. There is silver level evidence that manual therapy is more effective than exercise for those with hip OA in the short and long-term. Due to the small number of RCTs and patients, this evidence could be considered to be inconclusive regarding the benefit of manual therapy on pain and function for knee or hip OA.

The Efficacy of Manual Therapy in Patients with Knee Osteoarthritis: A Systematic Review

Medicina, 2021

Background and objectives: Osteoarthritis (OA) is among the most common degenerative diseases that induce pain, stiffness and reduced functionality. Various physiotherapy techniques and methods have been used for the treatment of OA, including soft tissue techniques, therapeutic exercises, and manual techniques. The primary aim of this systemic review was to evaluate the short-and long-term efficacy of manual therapy (MT) in patients with knee OA in terms of decreasing pain and improving knee range of motion (ROM) and functionality. Materials and Methods: A computerised search on the PubMed, PEDro and CENTRAL databases was performed to identify controlled randomised clinical trials (RCTs) that focused on MT applications in patients with knee OA. The keywords used were ‘knee OA’, ‘knee arthritis’, ‘MT’, ‘mobilisation’, ‘ROM’ and ‘WOMAC’. Results: Six RCTs and randomised crossover studies met the inclusion criteria and were included in the final analysis. The available studies indicat...

Clinical effectiveness of manual therapy for the management of musculoskeletal and non-musculoskeletal conditions: systematic review and update of UK evidence report

Chiropractic & manual therapies, 2014

This systematic review updated and extended the "UK evidence report" by Bronfort et al. (Chiropr Osteopath 18:3, 2010) with respect to conditions/interventions that received an 'inconclusive' or 'negative' evidence rating or were not covered in the report. A literature search of more than 10 general medical and specialised databases was conducted in August 2011 and updated in March 2013. Systematic reviews, primary comparative studies and qualitative studies of patients with musculoskeletal or non-musculoskeletal conditions treated with manual therapy and reporting clinical outcomes were included. Study quality was assessed using standardised instruments, studies were summarised, and the results were compared against the evidence ratings of Bronfort. These were either confirmed, updated, or new categories not assessed by Bronfort were added. 25,539 records were found; 178 new and additional studies were identified, of which 72 were systematic reviews, 96 we...

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Therapeutic Exercises and Manual Therapy in the Management of Osteoarthritis

Physical therapy, 2005

Background and Purpose. Osteoarthritis (OA) affects a large and growing proportion of the population. The purpose of this project was to create guidelines for the use of therapeutic exercises and manual therapy in the management of adult patients (Ͼ18 years of age) with a diagnosis of OA. All stages of the disease were included in the analysis, and studies of patients who had recent surgery or other rheumatologic, musculoskeletal, or spinal problems or of subjects without known pathology or impairments were excluded. Methods. The Ottawa Methods Group used Cochrane Collaboration methods to find and synthesize evidence from comparative controlled trials and then asked stakeholder groups to nominate representatives to serve on a panel of experts. The Ottawa Panel agreed on criteria for grading the strength of the recommendations and their supporting evidence. Of the 609 potential articles on therapeutic exercises for OA that were identified, 113 were considered potentially relevant, and 26 randomized controlled trials and controlled clinical trials were ultimately used. Results. Sixteen positive recommendations of clinical benefit were developed for therapeutic exercises, especially strengthening exercises and general physical activity, particularly for the management of pain and improvement of functional status. Manual therapy combined with exercises also is recommended in the management of patients with OA. Discussion and Conclusion. The Ottawa Panel recommends the use of therapeutic exercises alone, or combined with manual therapy, for managing patients with OA. There were a total of 16 positive recommendations: 13 grade A and 3 grade Cϩ. The Ottawa Panel recommends the use of therapeutic exercises because of the strong evidence (grades A, B, and Cϩ) in the literature. [Ottawa Panel Evidence-Based Clinical Practice Guidelines for Therapeutic Exercises and Manual Therapy in the Management of Osteoarthritis.