Postoperative Management for Degenerative Spinal Conditions

Spinal Degenerative Disorder Clinical Trial

Official title:

Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184143
• Other study ID #: 140057
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 2018

Study information

• Verified date: June 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Degenerative Disorder

Intervention

Behavioral:
• CBPT
Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.

Other:
• Education
Patient education

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: J Pain. 2017 Apr;18(4):477. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.	Up to 12 months.
Primary	Brief Pain Inventory (BPI)	The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome	Up to 12 months after spine surgery
Primary	12-Item Short Form Health Survey (SF-12)	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.	Up to 12 months after spine surgery
Secondary	Physical Activity	Physical activity measured by a commercially available movement accelerometer	Up to 12 months after spine surgery