Clinical trial NCT02624687: Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
Official title: Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Low Back Pain Disability
timeFrame: 6 months
measure: Usual Low Back Pain
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life (Self-reported)
timeFrame: 6 months
measure: Mood
timeFrame: 6 months
measure: 50-ft Walk Test
timeFrame: 6 months
measure: Chair Stand Test
timeFrame: 6 months
measure: Timed up and go Test
timeFrame: 6 months
measure: Unloaded Reach Test
timeFrame: 6 months
measure: Presenteeism
timeFrame: 6 months
measure: Work Productivity
timeFrame: 6 months
measure: Physical Activity
timeFrame: 6 months
measure: Sedentary Behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Physical Activity and Weight Management Research Center
state: Pennsylvania
Study officials:
References:
citation: Barone Gibbs B, Hergenroeder AL, Perdomo SJ, Kowalsky RJ, Delitto A, Jakicic JM. Reducing sedentary behaviour to decrease chronic low back pain: the stand back randomised trial. Occup Environ Med. 2018 May;75(5):321-327. doi: 10.1136/oemed-2017-104732. Epub 2018 Jan 12.