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Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

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ClinicalTrials.gov Identifier: NCT00970008
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Other: Massage 30 min 2x/wk x4 wks then 1x/wk x4 wks Other: Massage 60 min 2x/wk for 4 wks then 1x/wk for 4 wks Other: Massage 30 min sessions 1x/wk for 8 wks Other: Massage 60 min session 1x/wk for 8 wks Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploring Massage Benefits for Arthritis of the Knee
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Massage 30 min - 2x wk for 4 wks & 1x wk for 4 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 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.
Active Comparator: Massage 60 min - 2x wk for 4 wks & 1x wkly 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 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.
Active Comparator: Massage 30 min sessions - 1x/wk for 8wks
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 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.
Active Comparator: Massage 60 min sessions - 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
 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
No Intervention: Usual Care Control
Continue on usual care for eight (8) week period.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in WOMAC (Western Ontario Multipurpose Arthritis Centers) Knee and Hip Osteoarthritis Index [ Time Frame: Six (6) months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Six (6) months ]
  2. Improvement in range of motion as measured by a goniometer. [ Time Frame: six (6) months ]
  3. Improvement in physical function as measured by time in seconds to walk fifty (50) feet on a level straight surface. [ Time Frame: six (6) months ]
  4. Reduction in pain as measured by the Visual Analog Scale (VAS) for pain. [ Time Frame: Six (6) months ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970008


Locations
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United States, Connecticut
Yale-Griffin Prevention Research Center/Griffin Hospital
Derby, Connecticut, United States, 06418
United States, New Jersey
Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center
Livingston, New Jersey, United States, 07039
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Yale University
Investigators
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Principal Investigator: Adam I Perlman, MD, MPH University of Medicine and Dentistry of New Jersey
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00970008    
Other Study ID Numbers: R01AT004623-01 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015
Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
Osteoarthritis
Knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 CD59 Antigens
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs