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Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study (StandBack)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
No intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh, Physical Activity and Weight Management Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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.

These subjects will receive no intervention.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Mood
Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points).
50-ft Walk Test
Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.
Chair Stand Test
Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.
Timed up and go Test
Timed up and go test (seconds). A lower time indicates better function.
Unloaded Reach Test
Distance on an unloaded reach test (cm). Greater distance indicates better function.
Presenteeism
Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).
Work Productivity
Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).
Physical Activity
Minutes per week of moderate-to-vigorous physical activity by self-report
Sedentary Behavior
Self-reported hours per day

Full Information

First Posted
October 13, 2015
Last Updated
February 20, 2019
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02624687
Brief Title
Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
Acronym
StandBack
Official Title
Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
These subjects will receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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..
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
No contact control
Primary Outcome Measure Information:
Title
Low Back Pain Disability
Description
Oswestry Disability Index. This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.
Time Frame
6 months
Title
Usual Low Back Pain
Description
Pain rated by Visual Analog Scale (Usual Back Pain). This score ranges from 1-10 where a higher score indicates worse pain.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life (Self-reported)
Description
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.
Time Frame
6 months
Title
Mood
Description
Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points).
Time Frame
6 months
Title
50-ft Walk Test
Description
Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.
Time Frame
6 months
Title
Chair Stand Test
Description
Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.
Time Frame
6 months
Title
Timed up and go Test
Description
Timed up and go test (seconds). A lower time indicates better function.
Time Frame
6 months
Title
Unloaded Reach Test
Description
Distance on an unloaded reach test (cm). Greater distance indicates better function.
Time Frame
6 months
Title
Presenteeism
Description
Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).
Time Frame
6 months
Title
Work Productivity
Description
Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).
Time Frame
6 months
Title
Physical Activity
Description
Minutes per week of moderate-to-vigorous physical activity by self-report
Time Frame
6 months
Title
Sedentary Behavior
Description
Self-reported hours per day
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Oswestry low back pain index >20% to ensure a moderate level of disability is present, thus minimizing a potential floor effect Currently perform deskwork at least 20 hours per week at a desk compatible with the sit-stand attachment Stable employment (at least 3 months at current job and plan to stay at current job for the next 6 months) Ability to obtain approval to install sit-stand workstation (i.e., from supervisor) Access to internet connection and email to complete assessment surveys Exclusion Criteria: Unable to provide informed consent Cardiovascular event in the last 6 months (e.g. heart attack, stoke, heart failure, revascularization procedure) Presence of a comorbid condition that would limit ability to reduce sedentary behavior (e.g. currently undergoing treatment for cancer) Back surgery in the past 3 months or planned in the next year Presence of a medical "red flag" for a serious spinal condition (cancer, compression fracture, signs or symptoms of root compression, infection) Inability to tolerate standing for any reason Currently using a sit-stand desk, standing desk, or wearable activity monitor Currently pregnant or planned pregnancy in the next 6 months Blood pressure >159/100 mmHg
Facility Information:
Facility Name
University of Pittsburgh, Physical Activity and Weight Management Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29330230
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. Erratum In: Occup Environ Med. 2018 Jun;75(6):474.
Results Reference
derived

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

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