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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | 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. |
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| Control | Placebo Comparator | These subjects will receive no intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mood |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, Physical Activity and Weight Management Research Center | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29330230 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Decreasing Sedentary Behavior |
| FG001 | Control | These subjects will receive no intervention. No intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Decreasing Sedentary Behavior |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT LOCF | Posted | Least Squares Mean | Standard Error | Oswestry Disability % | 6 months |
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Monthly during the 6 month study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Decreasing Sedentary Behavior |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Low Back Pain by >50% | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bethany Barone Gibbs | University of Pittsburgh | 4123834002 | 412 | bbarone@pitt.edu |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| No intervention | Other | No contact control |
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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 to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function. | 6 months |
| Chair Stand Test | Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function. | 6 months |
| Timed up and go Test | Timed up and go test (seconds). A lower time indicates better function. | 6 months |
| Unloaded Reach Test | Distance on an unloaded reach test (cm). Greater distance indicates better function. | 6 months |
| Presenteeism | Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points). | 6 months |
| Work Productivity | Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points). | 6 months |
| Physical Activity | Minutes per week of moderate-to-vigorous physical activity by self-report | 6 months |
| Sedentary Behavior | Self-reported hours per day | 6 months |
| BG001 | Control | These subjects will receive no intervention. No intervention |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Oswestry Disability Index, % | The Oswestry Disability Index is measured as a percent, ranges from 1-100, with a higher score indicating worse low back pain disability. | Mean | Standard Deviation | % |
|
These subjects will receive no intervention. No intervention |
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| 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. | ITT LOCF | Posted | Least Squares Mean | Standard Error | points (out of 10) | 6 months |
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| 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. | Posted | Mean | Standard Deviation | points | 6 months |
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| Secondary | Mood | Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points). | Posted | Mean | Standard Deviation | points | 6 months |
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| Secondary | 50-ft Walk Test | Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function. | Posted | Mean | Standard Deviation | seconds | 6 months |
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| Secondary | Chair Stand Test | Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function. | Posted | Mean | Standard Deviation | seconds | 6 months |
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| Secondary | Timed up and go Test | Timed up and go test (seconds). A lower time indicates better function. | Posted | Mean | Standard Deviation | seconds | 6 months |
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| Secondary | Unloaded Reach Test | Distance on an unloaded reach test (cm). Greater distance indicates better function. | Posted | Mean | Standard Deviation | cm | 6 months |
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| Secondary | Presenteeism | Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points). | Posted | Mean | Standard Deviation | points | 6 months |
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| Secondary | Work Productivity | Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points). | Posted | Mean | Standard Deviation | points | 6 months |
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| Secondary | Physical Activity | Minutes per week of moderate-to-vigorous physical activity by self-report | ITT LOCF | Posted | Least Squares Mean | Standard Error | minutes/week | 6 months |
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| Secondary | Sedentary Behavior | Self-reported hours per day | ITT LOCF | Posted | Least Squares Mean | Standard Error | hours/day | 6 months |
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| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
| EG001 | Control | These subjects will receive no intervention. No intervention | 0 | 14 | 0 | 14 | 5 | 14 |
| New weakness, numbness, tingling in lower legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Medical procedure | Musculoskeletal and connective tissue disorders | Systematic Assessment | Outpatient correction of previous knee surgery |
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