Enhancing the Effectiveness of Physical Therapy for People With Knee
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
Exercise therapy (ET) is effective as the first line of treatment for reducing pain and disability in patients with knee osteoarthritis (OA), but studies show its effects diminish considerably over time. 'Booster' intervention sessions (periodic face-to-face follow-up appointments following discharge from supervised therapy designed to review and progress the patient's home program, troubleshoot problems with the program, etc.) have been recommended to make beneficial effects endure however this recommendation has not been adequately tested. There are also indications that manual therapy (MT), manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, and passive stretching, when combined with ET, may improve the overall effectiveness of rehabilitation for reducing pain and disability, and, may significantly delay or reduce the need for total knee arthroplastic surgery and reduce medication intake in people with knee OA. However, current published evidence-based treatment guidelines indicate there is not enough data to make a definitive recommendation regarding the use of MT with ET in rehabilitation programs. Therefore, the overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions in the delivery of ET, and supplementing ET with MT techniques.The study will be a multi-center,randomized clinical trial, using a 2 x 2 factorial design (factor 1 = booster vs no booster, factor 2 = ET alone vs ET + MT). Three hundred subjects (100 per study site) with knee OA will be randomized to one of the following groups: 1) ET - no booster, 2) ET - with booster, 3) MT + ET - no booster sessions, 4) MT + ET - with booster sessions. Clinical outcome measures (WOMAC, knee pain, global rating of change and performance-based measures of function) will be taken at baseline (prior to randomization), at the completion of the initial therapy sessions (9 weeks) and at 1 year follow-up. The primary endpoint for clinical outcome will be the WOMAC at 1 year.For the cost effectiveness analysis, the primary cost outcome will be osteoarthritis treatment costs from the societal perspective, which will include health system costs for implementing each intervention, medical/surgical costs (primary, secondary, and tertiary care costs), and personal costs to participants (travel, non-funded medications, time off work, and quality-of-life burdens). The primary effectiveness outcome measure will be quality-adjusted life-years (QALYs), derived using quality of life utilities from EQ-5D scores. Cost and effectiveness values between interventions will be compared via incremental cost-effectiveness ratios, yielding incremental costs per QALY gained when a given intervention is chosen. Secondary analyses will examine cost-effectiveness from health system and from patient perspectives. Cost and effectiveness data will be obtained at 1 year and 2 year follow-ups. The 2 year follow-up will be the primary endpoint for the cost-effectiveness analysis.
Investigators
g. kelly fitzgerald
Professor, Department of Physical Therapy, University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: Change from baseline at 9 weeks, 1 year and 2 years
Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.
Secondary Outcomes
- Global Rating of Change(Change from baseline to 9 weeks, 1 and 2 years)
- Change in 30 second time chair rise test.(Change from Baseline to , 9 weeks, 1 year)
- Change in Center for Epidemiological Studies Depression Scale (CES-D)(Change from Baseline to 1year)
- OARSI Responder Criteria(9 weeks and 1 year)
- Cost/Utility Ratio(2 years)
- Change in Numeric Knee Pain Rating Scale(Change from Baseline to 9 weeks, 1 and 2 years)
- Change in Self-paced Walk Test Time(Change from Baseline to 9 weeks, 1 year)
- Change in Beck Anxiety Index (BAI)(Change from Baseline to 1 year)
- Change in Timed Up and Go Test Time(Change from Baseline to 9 weeks and 1 year)
- Change in EQ-5D(Change from Baseline to 1 and 2 years)
- Change in Pain belief screening instrument(Change in Baseline to 1 year)