Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study

Chronic Low Back Pain Clinical Trial

— StandBack  

Official title:

Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624687
• Other study ID #: PRO15060576
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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..

Other:
• No intervention
No contact control

Locations

Country	Name	City	State
United States	University of Pittsburgh, Physical Activity and Weight Management Research Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Back Pain Disability	Oswestry Disability Index. This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.	6 months
Primary	Usual Low Back Pain	Pain rated by Visual Analog Scale (Usual Back Pain). This score ranges from 1-10 where a higher score indicates worse pain.	6 months
Secondary	Quality of Life (Self-reported)	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.	6 months
Secondary	Mood	Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points).	6 months
Secondary	50-ft Walk Test	Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.	6 months
Secondary	Chair Stand Test	Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.	6 months
Secondary	Timed up and go Test	Timed up and go test (seconds). A lower time indicates better function.	6 months
Secondary	Unloaded Reach Test	Distance on an unloaded reach test (cm). Greater distance indicates better function.	6 months
Secondary	Presenteeism	Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).	6 months
Secondary	Work Productivity	Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).	6 months
Secondary	Physical Activity	Minutes per week of moderate-to-vigorous physical activity by self-report	6 months
Secondary	Sedentary Behavior	Self-reported hours per day	6 months