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Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Massage 30 min 2x/wk x4 wks then 1x/wk x4 wks
Massage 60 min 2x/wk for 4 wks then 1x/wk for 4 wks
Massage 30 min sessions 1x/wk for 8 wks
Massage 60 min session 1x/wk for 8 wks
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Yale-Griffin Prevention Research Center/Griffin Hospital
  • Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Massage 30 min - 2x wk for 4 wks & 1x wk for 4 wks

Massage 60 min - 2x wk for 4 wks & 1x wkly for 4 wks

Massage 30 min sessions - 1x/wk for 8wks

Massage 60 min sessions - 1x/wk for 8 wks

Usual Care Control

Arm Description

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

Continue on usual care for eight (8) week period.

Outcomes

Primary Outcome Measures

Improvement in WOMAC (Western Ontario Multipurpose Arthritis Centers) Knee and Hip Osteoarthritis Index

Secondary Outcome Measures

Safety
Improvement in range of motion as measured by a goniometer.
Improvement in physical function as measured by time in seconds to walk fifty (50) feet on a level straight surface.
Reduction in pain as measured by the Visual Analog Scale (VAS) for pain.

Full Information

First Posted
August 18, 2009
Last Updated
May 1, 2015
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00970008
Brief Title
Exploring Massage Benefits for Arthritis of the Knee
Acronym
EMBARK
Official Title
Exploring Massage Benefits for Arthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage 30 min - 2x wk for 4 wks & 1x wk for 4 wks
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Massage 60 min - 2x wk for 4 wks & 1x wkly for 4 wks
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Massage 30 min sessions - 1x/wk for 8wks
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Massage 60 min sessions - 1x/wk for 8 wks
Arm Type
Active Comparator
Arm Description
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
Arm Title
Usual Care Control
Arm Type
No Intervention
Arm Description
Continue on usual care for eight (8) week period.
Intervention Type
Other
Intervention Name(s)
Massage 30 min 2x/wk x4 wks then 1x/wk x4 wks
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Massage 60 min 2x/wk for 4 wks then 1x/wk for 4 wks
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Massage 30 min sessions 1x/wk for 8 wks
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Massage 60 min session 1x/wk for 8 wks
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in WOMAC (Western Ontario Multipurpose Arthritis Centers) Knee and Hip Osteoarthritis Index
Time Frame
Six (6) months
Secondary Outcome Measure Information:
Title
Safety
Time Frame
Six (6) months
Title
Improvement in range of motion as measured by a goniometer.
Time Frame
six (6) months
Title
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
Title
Reduction in pain as measured by the Visual Analog Scale (VAS) for pain.
Time Frame
Six (6) months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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: Knee pain Satisfaction of at least five of the following nine criteria: Age greater than 50 years Stiffness < 30 minutes Crepitus Bony tenderness Bony enlargement No palpable warmth ESR < 40 mm/hr 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam I Perlman, MD, MPH
Organizational Affiliation
University of Medicine and Dentistry of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-Griffin Prevention Research Center/Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
Siegler Center for Integrative Medicine - Saint Barnabas Ambulatory Care Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17159021
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.
Results Reference
background
PubMed Identifier
23035641
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.
Results Reference
derived
PubMed Identifier
22347369
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.
Results Reference
derived

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Exploring Massage Benefits for Arthritis of the Knee

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