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Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial.

ABSTRACT: In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination.We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks.WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3-32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1-12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose.Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials.ClinicalTrials.gov NCT00970008.

SUBMITTER: Perlman AI

PROVIDER: S-EPMC3275589 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial.

Perlman Adam I AI Ali Ather A Njike Valentine Yanchou VY Hom David D Davidi Anna A Gould-Fogerite Susan S Milak Carl C Katz David L DL

PloS one 20120208 2

<h4>Background</h4>In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination.<h4>Methods</h4>We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish mass ...[more]

PMID: 22347369

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Project description:BackgroundCurrent 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.ObjectiveExamine effects of whole-body massage on knee osteoarthritis, compared to active control (light-touch) and usual care.DesignMultisite 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.ParticipantsFive hundred fifty-one screened for eligibility, 222 adults with knee osteoarthritis enrolled, 200 completed 8-week assessments, and 175 completed 52-week assessments.InterventionSixty minutes of protocolized full-body massage or light-touch.Main measuresPrimary: 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 resultsAt 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.ConclusionsEfficacy 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 registrationclinicaltrials.gov NCT01537484.

Project description:BackgroundFew remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis.ObjectiveTo compare Tai Chi with standard physical therapy for patients with knee osteoarthritis.DesignRandomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985).SettingAn urban tertiary care academic hospital.Patients204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white).InterventionTai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise).MeasurementsThe primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life.ResultsAt 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred.LimitationPatients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined.ConclusionTai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis.Primary funding sourceNational Center for Complementary and Integrative Health of the National Institutes of Health.

Project description:BackgroundThere are no explicit guidelines or tools available to support clinicians in selecting exercise therapy modalities according to the characteristics of individual patients despite the apparent need.ObjectiveThis study develops a methodology based on a novel multiobjective optimization model and examines its feasibility as a decision support tool to support healthcare professionals in comparing different modalities and identifying the most preferred one based on a patient's needs.MethodsThirty-one exercise therapy modalities were considered from 21 randomized controlled trials. A novel interactive multiobjective optimization model was designed to characterize the efficacy of an exercise therapy modality based on five objectives: minimizing cost, maximizing pain reduction, maximizing disability improvement, minimizing the number of supervised sessions, and minimizing the length of the treatment period. An interactive model incorporates clinicians' preferences in finding the most preferred exercise therapy modality for each need. Multiobjective optimization methods are mathematical algorithms designed to identify the optimal balance between multiple conflicting objectives among available solutions/alternatives. They explicitly evaluate the conflicting objectives and support decision-makers in identifying the best balance. An experienced research-oriented physiotherapist was involved as a decision-maker in the interactive solution process testing the proposed decision support tool.ResultsThe proposed methodology design and interactive process of the tool, including preference information, graphs, and exercise suggestions following the preferences, can help clinicians to find the most preferred exercise therapy modality based on a patient's needs and health status; paving the way to individualize recommendations.ConclusionsWe examined the feasibility of our decision support tool using an interactive multiobjective optimization method designed to help clinicians balance between conflicting objectives to find the most preferred exercise therapy modality for patients with knee osteoarthritis. The proposed methodology is generic enough to be applied in any field of medical and healthcare settings, where several alternative treatment options exist.KEY MESSAGESWe demonstrate the potential of applying Interactive multiobjective optimization methods in a decision support tool to help clinicians compare different exercise therapy modalities and identify the most preferred one based on a patient's needs.The usability of the proposed decision support tool is tested and demonstrated in prescribing exercise therapy modalities to treat knee osteoarthritis patients.

Project description:Unlabelled: Osteoarthritis (OA) is the most widespread musculoskeletal disorder in adults. It leads to cartilage damage associated with subchondral bone changes and synovial inflammation, causing pain and disability. The present study aimed at evaluating the safety of a dose-escalation protocol of intra-articular injected adipose-derived stromal cells (ASCs) in patients with knee OA, as well as clinical efficacy as secondary endpoint. A bicentric, uncontrolled, open phase I clinical trial was conducted in France and Germany with regulatory agency approval for ASC expansion procedure in both countries. From April 2012 to December 2013, 18 consecutive patients with symptomatic and severe knee OA were treated with a single intra-articular injection of autologous ASCs. The study design consisted of three consecutive cohorts (six patients each) with dose escalation: low dose (2 × 10(6) cells), medium dose (10 × 10(6)), and high dose (50 × 10(6)). The primary outcome parameter was safety evaluated by recording adverse events throughout the trial, and secondary parameters were pain and function subscales of the Western Ontario and McMaster Universities Arthritis Index. After 6 months of follow-up, the procedure was found to be safe, and no serious adverse events were reported. Four patients experienced transient knee joint pain and swelling after local injection. Interestingly, patients treated with low-dose ASCs experienced significant improvements in pain levels and function compared with baseline. Our data suggest that the intra-articular injection of ASCs is a safe therapeutic alternative to treat severe knee OA patients. A placebo-controlled double-blind phase IIb study is being initiated to assess clinical and structural efficacy.SignificanceAlthough this phase I study included a limited number of patients without a placebo arm, it showed that local injection of autologous adipose-derived stem cells was safe and well tolerated in patients with knee osteoarthritis. This study also provides encouraging preliminary evidence of efficacy. Larger and controlled long-term studies are now mandatory to confirm whether this new strategy of cell therapy can improve pain and induce structural benefit in osteoarthritis.

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Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial.

Publications

Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial.

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