Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatments decreasing sedentary behavior, no intervention
Sponsor University of Pittsburgh
Start date October 2015
End date December 2016
Trial size 27 participants
Trial identifier NCT02624687, PRO15060576

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
decreasing sedentary behavior
(Placebo Comparator)
These subjects will receive no intervention.
no intervention

Primary Outcomes

Measure
Low Back Pain
time frame: 6 months
Low Back Pain
time frame: 6 months

Secondary Outcomes

Measure
Quality of Life
time frame: 6 months
Mood
time frame: 6 months
Physical Function
time frame: 6 months
Physical Function
time frame: 6 months
Physical Function
time frame: 6 months
Physical Function
time frame: 6 months
Work productivity
time frame: 6 months
Work productivity
time frame: 6 months
Healthcare costs
time frame: 6 months
Physical Activity
time frame: 6 months
Sedentary Behavior
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.