NCT01314183

Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis

Enhancing the Effectiveness of Physical Therapy for People With Knee

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Agency for Healthcare Research and Quality (AHRQ) · Federal
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
OTHER	Exercise	The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.
OTHER	manual therapy	The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings.

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-03-14
• Last updated: 2015-06-23

Locations

3 sites across 1 country: United States