Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

May 1, 2015 updated by: University of Medicine and Dentistry of New Jersey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Yale-Griffin Prevention Research Center/Griffin Hospital
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in WOMAC (Western Ontario Multipurpose Arthritis Centers) Knee and Hip Osteoarthritis Index
Time Frame: Six (6) months
Six (6) months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: Six (6) months
Six (6) months
Improvement in range of motion as measured by a goniometer.
Time Frame: six (6) months
six (6) months
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
six (6) months
Reduction in pain as measured by the Visual Analog Scale (VAS) for pain.
Time Frame: Six (6) months
Six (6) months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Yale University

Investigators

  • Principal Investigator: Adam I Perlman, MD, MPH, University of Medicine and Dentistry of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT004623-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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