Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis

Completed · Phase 2/Phase 3

Conditions studied: Osteoarthritis

In brief

The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions(periodic face-to-face follow-up appointments that take place several weeks or months following discharge from the supervised therapy program designed to review the patient's current rehabilitation program, troubleshoot any problems with the program, and make recommendations for program progression or modification) in the delivery of exercise therapy, and supplementing exercise therapy with manual therapy techniques(manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching and range of motion). The investigators will do this in a randomized, multi-center, clinical trial. The investigators hypothesize that adding manual therapy techniques will be more clinically effective than exercise alone and that using booster sessions will maintain longer term clinical effects and be more cost-effective than not using booster sessions.

Key facts

Study ID

NCT01314183

Run by

Agency for Healthcare Research and Quality (AHRQ)

People needed

300

Starts

2011-04-01

Expected to finish

2015-04-01

Last updated by the study team

2015-06-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 40 years of age or older
• Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the following 6 criteria:
• age > 50 years,
• morning stiffness of < 30 minutes,
• crepitus on active movement,
• tenderness of the bony margins of the joint,
• bony enlargement of the joint noted on exam,
• lack of palpable warmth of the synovium. Based on this criteria, a subject who is less than 50 years but has knee pain and 3 of the other 5 criteria would also be classified as having knee OA.

You may not qualify if…

• do not meet the ACR clinical criteria for knee OA,
• are scheduled for total knee arthroplasty (TKA) surgery,
• have undergone TJA surgery on any lower extremity joint,
• exhibit uncontrolled hypertension (i.e. individuals not currently taking medication for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg at rest),
• have complaints of low back pain or other lower extremity joint pain that affects function at the time of recruitment,
• have a history of neurological disorders that would affect lower extremity function (stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),
• are women who are pregnant.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Army-Baylor University — San Antonio, Texas, United States
• Intermountain Healthcare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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