Status:
COMPLETED
Exploring Massage Benefits for Arthritis of the Knee
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Yale University
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief 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 e...
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 acti...
Eligibility Criteria
Inclusion
- 35 years of age or greater.
- Written confirmation of OA of the knee as provided by the participant's physician.
- Radiographically-established OA of the knee.
- Pre-randomization score of 40 to 90 on the Visual Analog Pain Scale (0-100 mm scale).
- Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
- American College of Rheumatology defined OA of the knee:
- Knee pain
- Satisfaction of at least five of the following nine criteria:
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- Age greater than 50 years
- Stiffness \< 30 minutes
- Crepitus
- Bony tenderness
- Bony enlargement
- No palpable warmth
- ESR \< 40 mm/hr
- Rheumatoid Factor (RF) \< 1:40
Exclusion
- (no exclusion criterion may be present)
- Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
- Presence of cancer or other serious medical conditions.
- Signs or history of kidney or liver failure.
- Presence of asthma requiring the use of corticosteroid treatment.
- Use of oral corticosteroids within the past four weeks.
- Use of intra-articular knee depo-corticosteroids with the past three months.
- Use of intra-articular hyaluronate with the past six months.
- Arthroscopic surgery of the knee within the past year.
- Significant injury to the knee within the past six months.
- Presence of a rash or open wound over the knee.
- Unable to satisfy the treatment and follow-up requirements.
- Unable to provide written informed consent.
- Currently receiving massage therapy on a regular basis (at least twice a month).
- Knee replacement of study knee (ok if the knee not being studied has been replaced).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00970008
Start Date
September 1 2009
End Date
August 1 2011
Last Update
May 5 2015
Active Locations (2)
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1
Yale-Griffin Prevention Research Center/Griffin Hospital
Derby, Connecticut, United States, 06418
2
Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center
Livingston, New Jersey, United States, 07039