Osteoarthritis
Conditions
Keywords
massage, osteoarthritis, light touch, Swedish
Brief 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.
Interventions
PROCEDUREMassage Therapy
Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC) | Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain: The Visual Analog Scale (VAS) | Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) | 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. |
| Change in Pain: PROMIS Pain Interference Questionnaire | Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) | 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. |
| Change in Joint Flexibility | Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) | 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. |
| Change in Physical Function | Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) | Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities. |
Countries
United States
Outcome results
None listed