Osteoarthritis Clinical Trial
Official title:
Group Physical Therapy for Veterans With Knee Osteoarthritis
Pain management is a priority for the Department of Veterans Affairs (VA) health care system, and knee osteoarthritis (OA) is a main cause of chronic pain. Veterans who receive care within the VA health care system have higher rates and more severe OA than both the general population of adults and veterans who receive health care elsewhere. Physical therapy (PT) is a primary part of treatment for knee OA, but in the VA health care system PT appointments are a limited resource, and veterans often do not receive enough visits to promote long-term improvements in pain and physical function. New models of delivery, such as the group-based approach examined in this study, are needed to expand PT services in a cost-effective manner.
Knee osteoarthritis (OA) is one of the most common health problems and a leading cause of
disability among veterans. Physical therapy (PT) and ongoing exercise are associated with
reduced pain and improved physical function among patients with knee OA, yet the majority of
veterans with OA are physically inactive. Furthermore, PT services are a limited resource in
the VA health care system, with demand exceeding supply. VA patients with knee OA generally
receive only one or two PT visits. Prior research indicates this amount of clinical contact
time is not sufficient to provide patients with the assessment, instruction, and support
needed to adopt and maintain an exercise program, particularly in the context of a chronic
pain condition. Therefore development, testing, and implementation of mechanisms to
cost-effectively expand PT services for knee OA may play a key role in improving pain and
other outcomes in this large group of veterans. This research examines a group-based
approach to delivering PT for knee OA, which can extend services to more veterans, for a
greater number of sessions per veteran, at lower staffing costs. The objective of this study
is to compare the effectiveness of a group-based PT program for knee OA with usual
individual PT care for knee OA.
This study will be a randomized controlled trial of a 12-week, group-based PT program among
N=320 veterans with symptomatic knee OA at the Durham VA Medical Center (VAMC). Participants
will be randomly assigned to the group-based PT program or individual PT (usual care). The
group PT arm will include 6 1-hour visits (every other week) led by a physical therapist and
exercise physiologist or physical therapy assistant, with 8 participants per group. The
individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other
health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks
apart. The group PT sessions will include group instruction in joint care (activity pacing
and joint projection), group discussion of exercise successes and barriers, group exercise,
and scheduled individual consultations with the physical therapist (2 per participant, 15-20
minutes each) to address specific functional and therapeutic needs. While the individual PT
sessions will differ in structure, they will include the same informational, assessment, and
therapeutic content as the group sessions. Both groups will be given instructions for the
same home exercise program. The primary outcome for this study will be the Western Ontario
and McMasters Universities Osteoarthritis Index (WOMAC). The secondary outcome will be
objectively assessed physical function (Short Physical Performance Test Protocol). These
outcomes will be assessed at baseline and 12-week follow-up. The WOMAC will also be assessed
via telephone at 24-week follow-up to examine whether any observed intervention effects are
maintained. Mixed linear models will be used to compare outcomes for the two study arms. We
will also conduct an economic analysis of the group-based PT program.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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