Exploring Massage Benefits for Arthritis of the Knee - NCT00970008-06418 (Clinical Trial 319439)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy319439.aspx
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| City: |
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Derby |
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State:
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CT |
| Zip Code: |
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06418 |
| Conditions: |
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Osteoarthritis of the Knee |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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:
1. Knee pain
2. Satisfaction of at least five of the following nine criteria:
1. Age greater than 50 years
2. Stiffness < 30 minutes
3. Crepitus
4. Bony tenderness
5. Bony enlargement
6. No palpable warmth
7. ESR < 40 mm/hr
8. Rheumatoid Factor (RF) < 1:40
Exclusion Criteria: (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). |
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| Study is available at: |
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Yale-Griffin Prevention Research Center/Griffin Hospital
Derby, CT 06418
United States
Primary Contact:
David L Katz, MD, MPH
Email: david.katz@yale.edu
Phone: 203-732-7194
Secondary Contact:
Adam I Perlman, MD, MPH
Email: perlmaad@umdnj.edu
Phone: 973-972-8519 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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