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Exploring Massage Benefits for Arthritis of the Knee for VA Healthcare Users

NCT ID: NCT01714869

Last Updated: 2013-11-25

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to find out how effective and feasible an 8-week course of Swedish massage is, for reducing pain and increasing function in adults who are VA healthcare users, with osteoarthritis (OA) of the knee.

Detailed Description

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The goal of this supplement is to enroll n=25 VA healthcare users with knee OA into the initial 8-week EMBARK massage program in order to collect preliminary data on the feasibility, acceptability and efficacy of massage in this patient group, in preparation for a larger grant submission to evaluate the effectiveness of massage for knee OA in the VA healthcare system. All veterans enrolled under this supplement will complete the initial 8-week massage protocol, since this will allow us the maximum opportunity to assess the feasibility and gather preliminary efficacy data. Veterans with symptomatic knee OA will be recruited from the Durham VA Medical Center, and the remaining study activities will be completed at the Duke site of the EMBARK study.

Conditions

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Osteoarthritis

Keywords

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Swedish massage massage osteoarthritis knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Swedish Massage

Swedish Massage, once per week for 8 weeks, 60 minutes per session.

Group Type OTHER

Swedish Massage

Intervention Type OTHER

Swedish Massage, once per week for 8 weeks, 60 minutes per session.

Interventions

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Swedish Massage

Swedish Massage, once per week for 8 weeks, 60 minutes per session.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Be a veteran enrolled in care at the Durham VA Medical Center.
2. 35 years of age or greater.
3. Written confirmation of OA of the knee as provided by the participant's physician.
4. Radiographically-established OA of the knee.
5. Pre-randomization score in a specified range on the Visual Analog Pain Scale (0 - 100 mm scale).
6. 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.
7. Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
8. 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 greater than 50 years ii. Stiffness \< 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth

Exclusion Criteria

1. Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
2. Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
3. Signs or history of kidney or liver failure.
4. Presence of asthma requiring the use of corticosteroid treatment.
5. Use of oral corticosteroids within the past four weeks.
6. Use of intra-articular knee depo-corticosteroids with the past three months.
7. Use of intra-articular hyaluronate with the past six months.
8. Arthroscopic surgery of the knee within the past year.
9. Significant injury to the knee within the past six months.
10. Presence of a rash or open wound over the knee.
11. Unable to satisfy the treatment and follow-up requirements.
12. Unable to provide written informed consent.
13. Currently receiving massage therapy on a regular basis (at least twice a month).
14. Knee replacement of study knee (ok if the knee not being studied has been replaced).
15. History of participating in the EMBARK Phase I (2004) or II (2009) studies.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam I Perlman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke Integrative Medicine

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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3R01AT004623-05S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00040759

Identifier Type: -

Identifier Source: org_study_id