Clinical trial NCT01714869: Exploring Massage Benefits for Arthritis of the Knee for VA Healthcare Users
Official title: Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis for VA Healthcare Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Swedish massage
massage
osteoarthritis
knee
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
timeFrame: Baseline, and 8 weeks
Secondary outcomes:
measure: Change in Pain: The Visual Analog Scale (VAS)
timeFrame: Baseline and 8 weeks
measure: Change in Pain: PROMIS Pain Interference Questionnaire
timeFrame: Baseline and 8 weeks
measure: Change in Joint Flexibility
timeFrame: Baseline and 8 weeks
measure: Change in Physical Function
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
Study officials:
affiliation: Duke Health
name: Adam I Perlman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: