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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
Sponsor:
Information provided by (Responsible Party):
Bethany Barone Gibbs, University of Pittsburgh

Brief Summary:
This study will test the effects of a sedentary behavior intervention on low back pain in working adults. The behavioral intervention will include the use of a sit-stand desk and a wrist-worn activity prompter that will notify participants when they have been sedentary for too long.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Intervention Other: No intervention Not Applicable

Detailed Description:
Low back pain (LBP) is prevalent, debilitating and costly. Though exercise is a recommended treatment for LBP, outcomes are variable and adherence is often poor due to barriers such as time, sedentary jobs, and fear-avoidance of movement. Thus, the management of LBP must include a biobehavioral lifestyle treatment approach. Preliminary evidence suggests that prolonged sitting at work can exacerbate LBP, LBP is relieved shortly after prolonged sitting ends, and standing more at work can relieve pain. Thus, this proposal will examine an innovative intervention to decrease pain in patients with chronic LBP (cLBP) through a reduction in sedentary behavior. The target population will be University of Pittsburgh (UPitt) employees with cLBP who are inactive and sit at their desk for ≥20 hours/week. Over 6 months, individuals will be provided with a workstation that allows for standing while performing work duties, a wrist-worn activity device that vibrates after prolonged sedentariness, and a behavioral intervention including an initial orientation and monthly follow-up telephone contacts. This is a novel pain reduction approach that is easily incorporated into the workplace and targets a timeframe during which prolonged sitting is common. A unique aspect of the approach is that individuals with cLBP who avoid movement due to pain may especially benefit from this emerging strategy of more frequent, lifestyle activity facilitated by newly-available devices. The investigators hypothesize that this intervention will reduce pain intensity thereby leading to increased work productivity, decreased healthcare utilization, improved health-related quality of life, and improved physical function in LBP sufferers. If effective, this scalable intervention could be implemented broadly to enhance employee health.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Intervention
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 50-ft Walk Test [ Time Frame: 6 months ]
    Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.

  4. Chair Stand Test [ Time Frame: 6 months ]
    Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.

  5. Timed up and go Test [ Time Frame: 6 months ]
    Timed up and go test (seconds). A lower time indicates better function.

  6. Unloaded Reach Test [ Time Frame: 6 months ]
    Distance on an unloaded reach test (cm). Greater distance indicates better function.

  7. Presenteeism [ Time Frame: 6 months ]
    Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).

  8. Work Productivity [ Time Frame: 6 months ]
    Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).

  9. Physical Activity [ Time Frame: 6 months ]
    Minutes per week of moderate-to-vigorous physical activity by self-report

  10. Sedentary Behavior [ Time Frame: 6 months ]
    Self-reported hours per day



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have chronic low back pain defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months
  2. Oswestry low back pain index >20% to ensure a moderate level of disability is present, thus minimizing a potential floor effect
  3. Currently perform deskwork at least 20 hours per week at a desk compatible with the sit-stand attachment
  4. Stable employment (at least 3 months at current job and plan to stay at current job for the next 6 months)
  5. Ability to obtain approval to install sit-stand workstation (i.e., from supervisor)
  6. Access to internet connection and email to complete assessment surveys

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Cardiovascular event in the last 6 months (e.g. heart attack, stoke, heart failure, revascularization procedure)
  3. Presence of a comorbid condition that would limit ability to reduce sedentary behavior (e.g. currently undergoing treatment for cancer)
  4. Back surgery in the past 3 months or planned in the next year
  5. Presence of a medical "red flag" for a serious spinal condition (cancer, compression fracture, signs or symptoms of root compression, infection)
  6. Inability to tolerate standing for any reason
  7. Currently using a sit-stand desk, standing desk, or wearable activity monitor
  8. Currently pregnant or planned pregnancy in the next 6 months
  9. Blood pressure >159/100 mmHg

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): NCT02624687


Locations
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United States, Pennsylvania
University of Pittsburgh, Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bethany Barone Gibbs, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02624687     History of Changes
Other Study ID Numbers: PRO15060576
First Posted: December 8, 2015    Key Record Dates
Results First Posted: February 19, 2019
Last Update Posted: March 13, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms