Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study (StandBack)
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|ClinicalTrials.gov Identifier: NCT02624687|
Recruitment Status : Completed
First Posted : December 8, 2015
Results First Posted : February 19, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Behavioral: Intervention Other: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Intervention
These subjects will participate in a behavioral intervention that will focus on reducing sedentary behavior and improving self-management of pain. This will include an initial, in-person behavioral intervention and then monthly follow-up calls. In addition, subjects will receive a sit-stand desk attachment and a wrist-worn activity prompter to aid in sedentary behavior reduction.
Participants participated in monthly, individual counselling with a trained interventionist to decrease sedentary behavior and improve pain self-management. Participants were provided with a sit-stand desk attachment and a wrist worn activity prompter..
Placebo Comparator: Control
These subjects will receive no intervention.
Other: No intervention
No contact control
- Low Back Pain Disability [ Time Frame: 6 months ]Oswestry Disability Index. This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.
- Usual Low Back Pain [ Time Frame: 6 months ]Pain rated by Visual Analog Scale (Usual Back Pain). This score ranges from 1-10 where a higher score indicates worse pain.
- Quality of Life (Self-reported) [ Time Frame: 6 months ]36-item Short Form Survey (SF-36). This validated survey collects information on quality of life, with scores ranging from 0-100, and where higher scores indicate higher quality of life.The General Health Score is reported.
- Mood [ Time Frame: 6 months ]Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points).
- 50-ft Walk Test [ Time Frame: 6 months ]Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.
- Chair Stand Test [ Time Frame: 6 months ]Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.
- Timed up and go Test [ Time Frame: 6 months ]Timed up and go test (seconds). A lower time indicates better function.
- Unloaded Reach Test [ Time Frame: 6 months ]Distance on an unloaded reach test (cm). Greater distance indicates better function.
- Presenteeism [ Time Frame: 6 months ]Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).
- Work Productivity [ Time Frame: 6 months ]Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).
- Physical Activity [ Time Frame: 6 months ]Minutes per week of moderate-to-vigorous physical activity by self-report
- Sedentary Behavior [ Time Frame: 6 months ]Self-reported hours per day
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): NCT02624687
|United States, Pennsylvania|
|University of Pittsburgh, Physical Activity and Weight Management Research Center|
|Pittsburgh, Pennsylvania, United States, 15261|