Clinical trial NCT00970008: Exploring Massage Benefits for Arthritis of the Knee
Official title: Exploring Massage Benefits for Arthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Knee
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2009-09-02
Enrollment: 125
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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:

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  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).

Primary outcomes:
measure: Improvement in WOMAC (Western Ontario Multipurpose Arthritis Centers) Knee and Hip Osteoarthritis Index
timeFrame: Six (6) months
Secondary outcomes:
measure: Safety
timeFrame: Six (6) months
measure: Improvement in range of motion as measured by a goniometer.
timeFrame: six (6) months
measure: Improvement in physical function as measured by time in seconds to walk fifty (50) feet on a level straight surface.
timeFrame: six (6) months
measure: Reduction in pain as measured by the Visual Analog Scale (VAS) for pain.
timeFrame: Six (6) months
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale-Griffin Prevention Research Center/Griffin Hospital
state: Connecticut
city: Livingston
country: United States
facility: Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Adam I Perlman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ali 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.
citation: Perlman 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.