Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00970008
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date August 2011

See also
  Status Clinical Trial Phase
Completed NCT03277066 - A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis Phase 2
Recruiting NCT03090698 - Outcomes of Injections in Patients Waiting for Total Knee Replacement Phase 4
Completed NCT02556710 - A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee Phase 3
Withdrawn NCT02237846 - Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis Phase 1/Phase 2
Completed NCT02242435 - A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis Phase 3
Completed NCT02096393 - Patient Specific Instrumentation in TKR N/A
Completed NCT01849445 - Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study N/A
Completed NCT01704157 - A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device N/A
Active, not recruiting NCT01374230 - Long-Term Multicenter Evaluation of the E1® Tibial Bearing N/A
Completed NCT01410409 - Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement N/A
Completed NCT02156440 - Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee Phase 2
Not yet recruiting NCT01270412 - Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis Phase 2/Phase 3
Completed NCT01207115 - A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee Phase 2
Completed NCT01331278 - A Comparative Study of Knee Systems Phase 4
Completed NCT00988091 - Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee Phase 3
Completed NCT00792727 - HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain Phase 3
Completed NCT00531427 - Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee Phase 3
Completed NCT00449696 - Gel-200 Versus Placebo in Osteoarthritis of the Knee Phase 3
Completed NCT04145011 - Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain N/A
Completed NCT01430559 - Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee N/A