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

NCT01714869 | Completed DMC

• 2 other identifiers: Pro000407593R01AT004623-05S2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Swedish massage; massage; osteoarthritis; knee

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. The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy

  Baseline, and 8 weeks

Secondary Outcomes (4)

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

  Baseline and 8 weeks

• Change in Pain: PROMIS Pain Interference Questionnaire

  Baseline and 8 weeks

• Change in Joint Flexibility

  Baseline and 8 weeks

• Change in Physical Function

  Baseline and 8 weeks

Study Arms (1)

Swedish Massage

OTHER

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

Other: Swedish Massage

Interventions

Swedish Massage OTHER

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

Swedish Massage

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a veteran enrolled in care at the Durham VA Medical Center.
• 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 score in a specified 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 greater 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 (2004) or II (2009) studies.

Sponsors & Collaborators

• Duke University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Adam I Perlman, MD, MPH

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

US (1)