Postoperative Management for Degenerative Spinal Conditions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02184143|
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Degenerative Disorder||Behavioral: CBPT Other: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Experimental: CBPT intervention
CBPT program consisting of weekly phone calls.
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.
- 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.
- 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
- 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.
- Physical Activity [ Time Frame: Up to 12 months after spine surgery ]Physical activity measured by a commercially available movement accelerometer
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
|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|
|Principal Investigator:||Kristin R Archer, PT, PhD||Vanderbilt University|