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Postoperative Management for Degenerative Spinal Conditions

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ClinicalTrials.gov Identifier: NCT02184143
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kristin Archer, 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.

Condition or disease Intervention/treatment Phase
Spinal Degenerative Disorder Behavioral: CBPT Other: Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions
Study Start Date : August 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: CBPT intervention
CBPT program consisting of weekly phone calls.
Behavioral: CBPT
Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.

Active Comparator: Education intervention
Education program consisting of weekly phone calls.
Other: Education
Patient education




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Up to 12 months. ]
    The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.

  2. Brief Pain Inventory (BPI) [ Time Frame: Up to 12 months after spine surgery ]
    The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome

  3. 12-Item Short Form Health Survey (SF-12) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Physical Activity [ Time Frame: Up to 12 months after spine surgery ]
    Physical activity measured by a commercially available movement accelerometer



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184143


Locations
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United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kristin R Archer, PT, PhD Vanderbilt University
  Study Documents (Full-Text)

Documents provided by Kristin Archer, Vanderbilt University Medical Center:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristin Archer, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02184143    
Other Study ID Numbers: 140057
First Posted: July 9, 2014    Key Record Dates
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019
Last Verified: June 2019