Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

Duke University

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: Massage Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01537484

7R01AT004623-04 (U.S. NIH Grant/Contract)

Pro00032894

Details and patient eligibility

About

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.

Enrollment: 222 patients

Sex: All

Ages: 35+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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222 participants in 3 patient groups

Swedish Massage

Experimental group

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.

Treatment:

Procedure: Massage Therapy

Light Touch Bodywork

Active Comparator group

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.

Treatment:

Procedure: Massage Therapy

Usual Care

Other group

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.

Treatment:

Procedure: Massage Therapy