NCT01537484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 20, 2017

Status Verified

August 1, 2015

Enrollment Period

3 years

First QC Date

February 7, 2012

Last Update Submit

April 18, 2017

Conditions

Osteoarthritis

Keywords

massageosteoarthritislight touchSwedish

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

Secondary Outcomes (4)

  • Change in Pain: The Visual Analog Scale (VAS)

    Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

  • Change in Pain: PROMIS Pain Interference Questionnaire

    Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

  • Change in Joint Flexibility

    Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

  • Change in Physical Function

    Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

Study Arms (3)

Swedish Massage

EXPERIMENTAL

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.

Procedure: Massage Therapy

Light Touch Bodywork

ACTIVE COMPARATOR

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.

Procedure: Massage Therapy

Usual Care

OTHER

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.

Procedure: Massage Therapy

Interventions

Massage TherapyPROCEDURE

Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.

Also known as: Usual Care
Light Touch BodyworkSwedish MassageUsual Care

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Atlantic Health System -- Atlantic Health Integrative Medicine

Morristown, New Jersey, 07960, United States

Location

Duke University Medical Center- Duke Integrative Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • 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.

    PMID: 17159021RESULT

  • 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.

    PMID: 22347369RESULT

  • 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.

    PMID: 30543021DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Massage

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Adam Perlman, MD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 23, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 20, 2017

Record last verified: 2015-08

Locations

US(3)