Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02498847 |
| Other study ID # |
HUM00067979 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
March 2013 |
| Est. completion date |
January 2015 |
Study information
| Verified date |
April 2023 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and
disability. Non-pharmacological interventions are recommended but are underutilized. Exercise
reduces pain and improves physical function, but benefits tend to wane without a component to
facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain
and physical function in individuals with OA, but is not typically offered in clinical care.
CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help
people manage chronic conditions by teaching behavioral strategies that promote health and
function. The purpose of this study is to test the feasibility and efficacy of an
OT-delivered cognitive behavioral therapy program to help people manage their knee OA.
Description:
Knee OA, in particular, is a major driver of health care costs and is also a leading cause of
arthritis-related activity limitations. A common assumption in knee OA treatment is that
relief of joint pain will lead to improvements in physical function. However, many factors
can influence disability in OA, not only the biomechanical factors which have been the focus
of traditional rehabilitation. Although research supports a broader biopsychosocial approach
to knee OA treatment, it has not been broadly adopted into clinical treatments. The
biopsychosocial model posits that pain and disability are not only affected by pathophysical
(e.g., biological) factors, but also psychological (e.g., depression, coping, self-efficacy)
and social factors (e.g., social support, response of significant other).
One approach to offering psychosocial aspects in the context of pain treatment has been via
CBT, a common psychosocial intervention, with evidence supporting its efficacy in OA. Despite
the evidence, CBT is rarely integrated into actual clinical practice for people with knee OA.
Barriers to integration have included limited access to psychologists (particularly in rural
settings), difficulties coordinating primary care physicians with psychological practices,
inconsistent reimbursement of psychological services for OA pain, and inconsistent
standardization of treatments across settings. The current study aims to overcome barriers
that have previously limited access to a biopsychosocial approach to knee OA treatments by
integrating cognitive and behaviorally-based self-management training into a new
rehabilitation intervention offered through occupational therapy, an allied medical field
which commonly teaches behavioral strategies to improve physical function in many clinical
populations. Because this approach will be manualized, it will provide the opportunity for
easy adoption into clinical practice.
