Exploring Massage Benefits for Arthritis of the Knee
EMBARK
1 other identifier
interventional
125
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMay 5, 2015
April 1, 2015
1.8 years
August 18, 2009
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in WOMAC (Western Ontario Multipurpose Arthritis Centers) Knee and Hip Osteoarthritis Index
Six (6) months
Secondary Outcomes (4)
Safety
Six (6) months
Improvement in range of motion as measured by a goniometer.
six (6) months
Improvement in physical function as measured by time in seconds to walk fifty (50) feet on a level straight surface.
six (6) months
Reduction in pain as measured by the Visual Analog Scale (VAS) for pain.
Six (6) months
Study Arms (5)
Massage 30 min - 2x wk for 4 wks & 1x wk for 4 wks
ACTIVE COMPARATORSwedish 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.
Massage 60 min - 2x wk for 4 wks & 1x wkly for 4 wks
ACTIVE COMPARATORSwedish 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.
Massage 30 min sessions - 1x/wk for 8wks
ACTIVE COMPARATORSwedish massage session of 30 minutes duration, once weekly for eight weeks over a eight (8) week period. Total intervention = 8 sessions for 240 minutes.
Massage 60 min sessions - 1x/wk for 8 wks
ACTIVE COMPARATORSwedish massage session of 60 minutes duration, once weekly for eight weeks over a eight (8) week period. Total intervention = 8 sessions for 480 minutes
Usual Care Control
NO INTERVENTIONContinue on usual care for eight (8) week period.
Interventions
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.
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Yale-Griffin Prevention Research Center/Griffin Hospital
Derby, Connecticut, 06418, United States
Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center
Livingston, New Jersey, 07039, United States
Related Publications (3)
Perlman AI, Sabina A, Williams AL, Njike VY, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized controlled trial. Arch Intern Med. 2006 Dec 11-25;166(22):2533-8. doi: 10.1001/archinte.166.22.2533.
PMID: 17159021BACKGROUNDAli A, Kahn J, Rosenberger L, Perlman AI. Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis. Trials. 2012 Oct 4;13:185. doi: 10.1186/1745-6215-13-185.
PMID: 23035641DERIVEDPerlman AI, Ali A, Njike VY, Hom D, Davidi A, Gould-Fogerite S, Milak C, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial. PLoS One. 2012;7(2):e30248. doi: 10.1371/journal.pone.0030248. Epub 2012 Feb 8.
PMID: 22347369DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam I Perlman, MD, MPH
University of Medicine and Dentistry of New Jersey
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
September 2, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
May 5, 2015
Record last verified: 2015-04