Exploring Massage Benefits for Arthritis of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Swedish Massage

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.

Group Type EXPERIMENTAL

Massage Therapy

Intervention Type PROCEDURE

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

Light Touch Bodywork

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.

Group Type ACTIVE_COMPARATOR

Massage Therapy

Intervention Type PROCEDURE

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

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.

Group Type OTHER

Massage Therapy

Intervention Type PROCEDURE

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

Interventions

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Massage Therapy

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

Intervention Type PROCEDURE

Other Intervention Names

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Usual Care

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No