Clinical trial NCT01314183: Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis
Official title: Enhancing the Effectiveness of Physical Therapy for People With Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Keywords: Knee
Physical Therapy
Exercise
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2011-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Change from baseline at 9 weeks, 1 year and 2 years
Secondary outcomes:
measure: Cost/Utility Ratio
timeFrame: 2 years
measure: Change in Numeric Knee Pain Rating Scale
timeFrame: Change from Baseline to 9 weeks, 1 and 2 years
measure: Global Rating of Change
timeFrame: Change from baseline to 9 weeks, 1 and 2 years
measure: Change in Timed Up and Go Test Time
timeFrame: Change from Baseline to 9 weeks and 1 year
measure: Change in 30 second time chair rise test.
timeFrame: Change from Baseline to , 9 weeks, 1 year
measure: Change in Self-paced Walk Test Time
timeFrame: Change from Baseline to 9 weeks, 1 year
measure: Change in Pain belief screening instrument
timeFrame: Change in Baseline to 1 year
measure: Change in Beck Anxiety Index (BAI)
timeFrame: Change from Baseline to 1 year
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change from Baseline to 1year
measure: Change in EQ-5D
timeFrame: Change from Baseline to 1 and 2 years
measure: OARSI Responder Criteria
timeFrame: 9 weeks and 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: San Antonio
country: United States
facility: Army-Baylor University
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
affiliation: University of Pittsburgh
name: G. Kelley Fitzgerald, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Healthcare, Salt Lake City, UT
name: Julie M Fritz, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Army-Baylor University, San Antonio, TX
name: John D Childs, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Otago, Dunedin, New Zealand
name: J. Haxby Abbott, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bove AM, Smith KJ, Bise CG, Fritz JM, Childs JD, Brennan GP, Abbott JH, Fitzgerald GK. Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial. Phys Ther. 2018 Jan 1;98(1):16-27. doi: 10.1093/ptj/pzx104.
citation: Fitzgerald GK, Fritz JM, Childs JD, Brennan GP, Talisa V, Gil AB, Neilson BD, Abbott JH. Exercise, manual therapy, and use of booster sessions in physical therapy for knee osteoarthritis: a multi-center, factorial randomized clinical trial. Osteoarthritis Cartilage. 2016 Aug;24(8):1340-9. doi: 10.1016/j.joca.2016.03.001. Epub 2016 Mar 10.