Postoperative Management for Degenerative Spinal Conditions

Not Applicable

Completed

• Conditions: Spinal Degenerative Disorder
• Interventions: Behavioral: CBPT; Other: Education

• Registration Number: NCT02184143
• Lead Sponsor: Vanderbilt University Medical Center

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 (CBPT) program focusing on self-management strategies or an education program about postoperative recovery - are more effective for improving patient-centered outcomes in older adults recovering from lumbar spine surgery for degenerative conditions. Our central hypothesis is that the CBPT intervention focusing on self-management will decrease pain and disability and improve general health, physical activity and physical function in community-dwelling adults undergoing spine surgery, through reductions in fear of movement and increases in pain self-efficacy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-09
• Study Start: 2014-08
• Primary Completion: 2017-11
• Study Completion: 2018-01
• Results First Submitted: 2018-03-01
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Results First Posted: 2019-08-02
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

1. Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes
2. Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis procedures
3. English speaking due to feasibility of employing study personnel to deliver and assess the study intervention
4. Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition).

Exclusion Criteria

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)
3. Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor
4. Presence of back and/or lower extremity pain < 3 months indicating no history of chronic pain
5. 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
6. Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder
7. Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel limitation
8. Patients having surgery under a workman's compensation claim
9. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBPT intervention	CBPT	CBPT program consisting of weekly phone calls.
Education intervention	Education	Education program consisting of weekly phone calls.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Up to 12 months.	The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.
12-Item Short Form Health Survey (SF-12)	Up to 12 months after spine surgery	The SF-12 is a measure of general physical and mental health. The SF-12 is scored from 0 to 100, with higher scores indicating better health.
Brief Pain Inventory (BPI)	Up to 12 months after spine surgery	The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome

Secondary Outcome Measures

Name	Time	Method
Physical Activity	Up to 12 months after spine surgery	Physical activity measured by a commercially available movement accelerometer

Trial Locations

Locations (2)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States