Postoperative Management for Degenerative Spinal Conditions

Status:	Recruiting
Healthy:	No
Age Range:	21 - 90
Updated:	4/21/2016
Start Date:	August 2014
End Date:	April 2017
Contact:	Christine Haug, BA
Email:	chrissy.m.haug@vanderbilt.edu
Phone:	615-936-3439

Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions

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.

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.

We found this trial at

sites

Johns Hopkins School of Medicine

Baltimore, Maryland 21287

Principal Investigator: Stephen Wegener, PhD

from

Baltimore, MD