Spinal Stenosis Clinical Trial
— CBPTOfficial title:
Cognitive-Behavioral Based Physical Therapy: Improving Surgical Spine Outcomes
Verified date | July 2014 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The overall objective of this application is to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. Our central hypothesis is that incorporating cognitive and behavioral strategies into postoperative standard of care PT will improve surgical outcomes, through reductions in fear of movement and pain catastrophizing. We have established the feasibility of training therapists in the CBPT intervention, recruiting and retaining patients, and the procedures for data collection and study management. The long-term goal is to broaden the availability of well-accepted and effective CBT strategies by expanding the implementation from traditional providers, psychologists, to a group of providers, physical therapists, who routinely interact with musculoskeletal pain populations.
Status | Completed |
Enrollment | 86 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
English speaking adults of both sexes and all races scheduled for lumbar spine surgery for
a degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and
spondylolisthesis) will be considered for study participation. Inclusion criteria will include the following: 1. Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes; 2. Surgical treatment using laminectomy with or without arthrodesis (i.e., fusion); 3. Presence of back and/or lower extremity pain > 6 months; 4. No history of neurological movement disorder; 5. No presence of psychotic disease; and 6. TSK score > 39 Exclusion criteria will include the following: 1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or laminectomy without arthrodesis); 2. Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion population); and 3. Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Orthopaedic Institute | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index | The ODI measures disability | 6 months post-discharge from therapy | No |
Secondary | Brief Pain Inventory (BPI) | The BPI measures pain intensity and pain interference | 6 months post-discharge from therapy | No |
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