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Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage Therapy
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis focused on measuring massage, osteoarthritis, light touch, Swedish

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 rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale).
  • Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
  • 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; specifically:

    a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness < 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth

Exclusion Criteria:

  • Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
  • Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
  • 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).
  • History of participating in the EMBARK Phase I or II studies.

Sites / Locations

  • Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital
  • Atlantic Health System -- Atlantic Health Integrative Medicine
  • Duke University Medical Center- Duke Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Swedish Massage

Light Touch Bodywork

Usual Care

Arm Description

Swedish massage for one hour, once per week, for eight weeks. At week 10, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), and 50% will be randomized to Usual Care.

Light-touch bodywork for one hour, once per week, for eight weeks. At week 10, 50% of the patients will be randomized to a maintenance dose (one hour of light-touch massage every two weeks, and 50% will be randomized to Usual Care.

Those initially randomized to the usual care control will be rolled into the Swedish massage intervention (one hour of Swedish massage, once/week for eight weeks) at week 25. At week 34, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), while 50% will be randomized back to Usual Care.

Outcomes

Primary Outcome Measures

Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis through 24 questions. WOMAC 3.1 is available in 65 languages using either a five-point Likert scale or a 100 mm visual analog scale. The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy

Secondary Outcome Measures

Change in Pain: The Visual Analog Scale (VAS)
Used to measure pain sensation intensity evoked by nociceptive stimuli. Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale. Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable). The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."
Change in Pain: PROMIS Pain Interference Questionnaire
Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status. The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.
Change in Joint Flexibility
Joint flexibility is defined as the range of motion (ROM) allowed at the knee. The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. This is measured using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint.
Change in Physical Function
Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.

Full Information

First Posted
February 7, 2012
Last Updated
April 18, 2017
Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01537484
Brief Title
Exploring Massage Benefits for Arthritis of the Knee
Acronym
EMBARK
Official Title
Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with OA of the knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
massage, osteoarthritis, light touch, Swedish

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Swedish Massage
Arm Type
Experimental
Arm Description
Swedish massage for one hour, once per week, for eight weeks. At week 10, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), and 50% will be randomized to Usual Care.
Arm Title
Light Touch Bodywork
Arm Type
Active Comparator
Arm Description
Light-touch bodywork for one hour, once per week, for eight weeks. At week 10, 50% of the patients will be randomized to a maintenance dose (one hour of light-touch massage every two weeks, and 50% will be randomized to Usual Care.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Those initially randomized to the usual care control will be rolled into the Swedish massage intervention (one hour of Swedish massage, once/week for eight weeks) at week 25. At week 34, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), while 50% will be randomized back to Usual Care.
Intervention Type
Procedure
Intervention Name(s)
Massage Therapy
Other Intervention Name(s)
Usual Care
Intervention Description
Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
Description
The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis through 24 questions. WOMAC 3.1 is available in 65 languages using either a five-point Likert scale or a 100 mm visual analog scale. The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy
Time Frame
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Secondary Outcome Measure Information:
Title
Change in Pain: The Visual Analog Scale (VAS)
Description
Used to measure pain sensation intensity evoked by nociceptive stimuli. Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale. Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable). The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."
Time Frame
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Title
Change in Pain: PROMIS Pain Interference Questionnaire
Description
Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status. The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.
Time Frame
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Title
Change in Joint Flexibility
Description
Joint flexibility is defined as the range of motion (ROM) allowed at the knee. The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. This is measured using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint.
Time Frame
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Title
Change in Physical Function
Description
Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.
Time Frame
Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

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 rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale). Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist. 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; specifically: a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness < 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth Exclusion Criteria: Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout. Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits. 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). History of participating in the EMBARK Phase I or II studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Perlman, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
Atlantic Health System -- Atlantic Health Integrative Medicine
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Duke University Medical Center- Duke Integrative Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
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
result
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
result
PubMed Identifier
30543021
Citation
Perlman A, Fogerite SG, Glass O, Bechard E, Ali A, Njike VY, Pieper C, Dmitrieva NO, Luciano A, Rosenberger L, Keever T, Milak C, Finkelstein EA, Mahon G, Campanile G, Cotter A, Katz DL. Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial. J Gen Intern Med. 2019 Mar;34(3):379-386. doi: 10.1007/s11606-018-4763-5. Epub 2018 Dec 12.
Results Reference
derived
Links:
URL
http://www.dukeintegrativemedicine.org
Description
Duke Integrative Medicine

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Exploring Massage Benefits for Arthritis of the Knee

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