- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624687
Reducing Sedentary Behavior to Decrease Low Back Pain: Stand Back Study (StandBack)
February 20, 2019 updated by: Bethany Barone Gibbs, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh, Physical Activity and Weight Management Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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..
|
Placebo Comparator: Control
These subjects will receive no intervention.
|
No contact control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low Back Pain Disability
Time Frame: 6 months
|
Oswestry Disability Index.
This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.
|
6 months
|
Usual Low Back Pain
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (Self-reported)
Time Frame: 6 months
|
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
|
Mood
Time Frame: 6 months
|
Profile of Mood States Questionnaire.
Total mood disturbance score reported here.
Higher scores indicate higher mood disturbance (range 0-200 points).
|
6 months
|
50-ft Walk Test
Time Frame: 6 months
|
Time to complete 50 ft.
walk test (seconds) at usual pace.
Lower time indicates better function.
|
6 months
|
Chair Stand Test
Time Frame: 6 months
|
Time to complete 5 sit-to-stand transitions (seconds).
Lower time indicates better function.
|
6 months
|
Timed up and go Test
Time Frame: 6 months
|
Timed up and go test (seconds).
A lower time indicates better function.
|
6 months
|
Unloaded Reach Test
Time Frame: 6 months
|
Distance on an unloaded reach test (cm).
Greater distance indicates better function.
|
6 months
|
Presenteeism
Time Frame: 6 months
|
Stanford Presenteeism Scale.
A higher score indicates higher presenteeism (range 6-30 points).
|
6 months
|
Work Productivity
Time Frame: 6 months
|
Health and Work Questionnaire.
Higher total score indicates better work productivity (range 0-240 points).
|
6 months
|
Physical Activity
Time Frame: 6 months
|
Minutes per week of moderate-to-vigorous physical activity by self-report
|
6 months
|
Sedentary Behavior
Time Frame: 6 months
|
Self-reported hours per day
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
October 13, 2015
First Submitted That Met QC Criteria
December 4, 2015
First Posted (Estimate)
December 8, 2015
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO15060576
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.Active, not recruitingChronic Pain | Chronic Low Back PainUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed