NCT00970008

Exploring Massage Benefits for Arthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A dual-site, randomized, dose-ranging trial to determine the role and practice parameters for massage in the standard clinical management of OA based on investigation of efficacy and mechanism of action. The study hypothesis is that an 8 week course of Swedish massage therapy will be effective in reducing pain and improving function in patients with confirmed OA of the knee. A future phase III trial is planned to test the optimal massage intervention identified in this study against a validated sham/control intervention, incorporating all pertinent outcome measures from the antecedent studies. In addition, this study will further the development of robust methodologies to test the efficacy of massage interventions in general. The research agenda advanced by the current study will culminate with the establishment of the proper place for massage therapy among standard treatment options for the millions of Americans suffering with osteoarthritis.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-07-01
• Completion: 2011-08-01
• First posted: 2009-09-02
• Last updated: 2015-05-05

Locations

2 sites across 1 country: United States