Clinical trial NCT02184143: Postoperative Management for Degenerative Spinal Conditions
Official title: Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Degenerative Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-07-09
Enrollment: 248
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Up to 12 months.
measure: Brief Pain Inventory (BPI)
timeFrame: Up to 12 months after spine surgery
measure: 12-Item Short Form Health Survey (SF-12)
timeFrame: Up to 12 months after spine surgery
Secondary outcomes:
measure: Physical Activity
timeFrame: Up to 12 months after spine surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Kristin R Archer, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Archer KR, Motzny N, Abraham CM, Yaffe D, Seebach CL, Devin CJ, Spengler DM, McGirt MJ, Aaronson OS, Cheng JS, Wegener ST. Cognitive-behavioral-based physical therapy to improve surgical spine outcomes: a case series. Phys Ther. 2013 Aug;93(8):1130-9. doi: 10.2522/ptj.20120426. Epub 2013 Apr 18.
citation: Archer KR, Devin CJ, Vanston SW, Koyama T, Phillips SE, Mathis SL, George SZ, McGirt MJ, Spengler DM, Aaronson OS, Cheng JS, Wegener ST. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial. J Pain. 2016 Jan;17(1):76-89. doi: 10.1016/j.jpain.2015.09.013. Epub 2015 Oct 23.
citation: Archer KR, Coronado RA, Haug CM, Vanston SW, Devin CJ, Fonnesbeck CJ, Aaronson OS, Cheng JS, Skolasky RL, Riley LH 3rd, Wegener ST. A comparative effectiveness trial of postoperative management for lumbar spine surgery: changing behavior through physical therapy (CBPT) study protocol. BMC Musculoskelet Disord. 2014 Oct 1;15:325. doi: 10.1186/1471-2474-15-325.