Exploring Massage Benefits for Arthritis of the Knee
NCT00970008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2015-05-05
Summary
In 2004, we conducted a pilot randomized, wait list controlled, trial (RCT) of massage therapy for OA of the knee in 68 subjects. That study, supported by CDC grant SIP-14-00, revealed the potential efficacy of Swedish massage therapy in the treatment of OA of the knee, with benefits of increased function and decreased pain persisting at least eight weeks following treatment cessation. The results of that trial, the first RCT of massage for OA, were published in the Archives of Internal Medicine in 2006 (See reference in More Information section). This current project builds on the design and findings of the pilot trial to determine the optimal dose and treatment regimen and provide longer term follow up. This project is a dual-site, randomized, dose-ranging trial to compare four dose/regimens in order to identify the optimal protocol for clinical practice.
The primary study hypothesis is that an eight (8) week course of Swedish massage therapy of one of the four proposed doses (by frequency and duration of massage treatment session) will be effective in reducing pain and improving function in patients with confirmed OA of the knee.
Conditions
- Osteoarthritis of the Knee
Interventions
- OTHER
-
Massage 30 min 2x/wk x4 wks then 1x/wk x4 wks
Swedish massage session of 30 minutes duration, twice weekly for four weeks followed by once weekly for four weeks over a eight (8) week period. Total intervention = 12 sessions for 360 minutes.
- OTHER
-
Massage 60 min 2x/wk for 4 wks then 1x/wk for 4 wks
Swedish massage session of 60 minutes duration, twice weekly for four weeks followed by once weekly for four weeks over a eight (8) week period. Total intervention = 12 sessions for 720 minutes.
- OTHER
-
Massage 30 min sessions 1x/wk for 8 wks
Swedish massage session of 30 minutes duration, once weekly for eight weeks over a eight (8) week period. Total intervention = 8 sessions for 240 minutes.
- OTHER
-
Massage 60 min session 1x/wk for 8 wks
Swedish massage session of 60 minutes duration, once weekly for eight weeks over a eight (8) week period. Total intervention = 8 sessions for 480 minutes
Sponsors & Collaborators
-
Yale University
collaborator OTHER -
University of Medicine and Dentistry of New Jersey
lead OTHER
Principal Investigators
-
Adam I Perlman, MD, MPH · University of Medicine and Dentistry of New Jersey
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2011-07-31
- Completion
- 2011-08-31
Countries
- United States
Study Locations
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