Status:
COMPLETED
Postoperative Management for Degenerative Spinal Conditions
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Spinal Degenerative Disorder
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
The overall objective of this study is to conduct a two-group randomized control trial (RCT) to compare which of two treatments provided by telephone - a cognitive-behavioral based physical therapy (C...
Eligibility Criteria
Inclusion
- Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes
- Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis procedures
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention
- Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition).
Exclusion
- 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)
- 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)
- Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Presence of back and/or lower extremity pain \< 3 months indicating no history of chronic pain
- History of neurological disorder or disease, resulting in moderate to severe movement dysfunction. Including but not limited to Parkinson's disease, Multiple Sclerosis, Epilepsy, Brain tumors, Huntington's disease, Alzheimer's disease, Muscular Dystrophy, Stroke, Autonomic Nervous System disorders, Traumatic Brain Injury, Cerebral Palsy, and Amyotrophic Lateral Sclerosis
- Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder
- Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel limitation
- Patients having surgery under a workman's compensation claim
- Unable to provide a stable address and access to a telephone indicating the inability to participate in either the telephone-based CBPT or education program.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT02184143
Start Date
August 1 2014
End Date
January 1 2018
Last Update
August 2 2019
Active Locations (2)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232