Exploring Massage Benefits for Arthritis of the Knee

Osteoarthritis Clinical Trial

— EMBARK  

Official title:

Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537484
• Other study ID #: Pro00032894
• Secondary ID: 7R01AT004623-04
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: April 18, 2017
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Massage Therapy
Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.

Locations

Country	Name	City	State
United States	Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital	Derby	Connecticut
United States	Duke University Medical Center- Duke Integrative Medicine	Durham	North Carolina
United States	Atlantic Health System -- Atlantic Health Integrative Medicine	Morristown	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Perlman AI, Ali A, Njike VY, Hom D, Davidi A, Gould-Fogerite S, Milak C, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial. PLoS One. 2012;7(2):e30248. doi: 10.1371/journal.pone.0030248. Epub 2012 Feb 8. — View Citation

Perlman AI, Sabina A, Williams AL, Njike VY, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized controlled trial. Arch Intern Med. 2006 Dec 11-25;166(22):2533-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. WOMAC 3.1 is available in 65 languages using either a five-point Likert scale or a 100 mm visual analog scale. The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy	Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Secondary	Change in Pain: The Visual Analog Scale (VAS)	Used to measure pain sensation intensity evoked by nociceptive stimuli. Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale. Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable). The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."	Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Secondary	Change in Pain: PROMIS Pain Interference Questionnaire	Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status. The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.	Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Secondary	Change in Joint Flexibility	Joint flexibility is defined as the range of motion (ROM) allowed at the knee. The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. This is measured using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint.	Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
Secondary	Change in Physical Function	Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.	Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)

External Links

•   Duke Integrative Medicine