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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
Last Update Posted : May 2, 2017
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: Decreasing Sedentary Behavior 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.

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

U.S. FDA Resources

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: Decreasing Sedentary Behavior
Placebo Comparator: Control
These subjects will receive no intervention.
Other: No intervention



Primary Outcome Measures :
  1. Low Back Pain [ Time Frame: 6 months ]
    Oswestry Disability Index

  2. Low Back Pain [ Time Frame: 6 months ]
    Pain rated by Visual Analog Scale


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]
    SF-36

  2. Mood [ Time Frame: 6 months ]
    POMS Mood Questionnaire

  3. Physical Function [ Time Frame: 6 months ]
    Time to complete 50 ft. walk test (seconds)

  4. Physical Function [ Time Frame: 6 months ]
    Time to complete 5 sit-to-stand transitions (seconds)

  5. Physical Function [ Time Frame: 6 months ]
    Timed up and go test (seconds)

  6. Physical Function [ Time Frame: 6 months ]
    Distance on a loaded and unloaded reach test (cm)

  7. Work productivity [ Time Frame: 6 months ]
    Stanford Presenteeism Scale

  8. Work productivity [ Time Frame: 6 months ]
    Health and Work Questionnaire

  9. Healthcare costs [ Time Frame: 6 months ]
    Estimated cost ($) of utilization of medication, clinician visits, or low back pain-related procedures

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
United States, Pennsylvania
University of Pittsburgh, Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh

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
Last Update Posted: May 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms