Chronic Low Back Pain
Conditions
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.
Interventions
BEHAVIORALIntervention
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..
OTHERNo intervention
No contact control
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain Disability | 6 months | 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 | 6 months | Pain rated by Visual Analog Scale (Usual Back Pain). This score ranges from 1-10 where a higher score indicates worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 50-ft Walk Test | 6 months | Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function. |
| Chair Stand Test | 6 months | Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function. |
| Timed up and go Test | 6 months | Timed up and go test (seconds). A lower time indicates better function. |
| Unloaded Reach Test | 6 months | Distance on an unloaded reach test (cm). Greater distance indicates better function. |
| Quality of Life (Self-reported) | 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. |
| Work Productivity | 6 months | Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points). |
| Physical Activity | 6 months | Minutes per week of moderate-to-vigorous physical activity by self-report |
| Sedentary Behavior | 6 months | Self-reported hours per day |
| Presenteeism | 6 months | Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points). |
| Mood | 6 months | Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Control These subjects will receive no intervention.
No intervention | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | medical leave from work | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 9 | 51 years STANDARD_DEVIATION 13 | 52 years STANDARD_DEVIATION 11 |
| Oswestry Disability Index, % | 23.6 % STANDARD_DEVIATION 10.9 | 24.6 % STANDARD_DEVIATION 10.3 | 24.1 % STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 12 Participants | 22 Participants |
| Region of Enrollment United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 1 / 13 | 5 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
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.
Time frame: 6 months
Population: ITT LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Low Back Pain Disability | 12.1 Oswestry Disability % | Standard Error 2.3 |
| Control | Low Back Pain Disability | 19.6 Oswestry Disability % | Standard Error 2.2 |
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.
Time frame: 6 months
Population: ITT LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Usual Low Back Pain | 2.87 points (out of 10) | Standard Error 0.33 |
| Control | Usual Low Back Pain | 3.02 points (out of 10) | Standard Error 0.32 |
Secondary
50-ft Walk Test
Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 50-ft Walk Test | 10.67 seconds | Standard Deviation 1.38 |
| Control | 50-ft Walk Test | 11.09 seconds | Standard Deviation 2.31 |
Secondary
Chair Stand Test
Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Chair Stand Test | 10.05 seconds | Standard Deviation 1.96 |
| Control | Chair Stand Test | 10.42 seconds | Standard Deviation 2.69 |
Secondary
Mood
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Mood | 87.25 points | Standard Deviation 11.76 |
| Control | Mood | 102.67 points | Standard Deviation 31.58 |
Secondary
Physical Activity
Minutes per week of moderate-to-vigorous physical activity by self-report
Time frame: 6 months
Population: ITT LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Physical Activity | 300 minutes/week | Standard Error 53 |
| Control | Physical Activity | 195 minutes/week | Standard Error 52 |
Secondary
Presenteeism
Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Presenteeism | 27.83 points | Standard Deviation 3.49 |
| Control | Presenteeism | 25.08 points | Standard Deviation 5.78 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Life (Self-reported) | 73.33 points | Standard Deviation 11.55 |
| Control | Quality of Life (Self-reported) | 62.08 points | Standard Deviation 21.05 |
Secondary
Sedentary Behavior
Self-reported hours per day
Time frame: 6 months
Population: ITT LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Sedentary Behavior | 7.3 hours/day | Standard Error 0.4 |
| Control | Sedentary Behavior | 9.0 hours/day | Standard Error 0.4 |
Secondary
Timed up and go Test
Timed up and go test (seconds). A lower time indicates better function.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Timed up and go Test | 7.49 seconds | Standard Deviation 1.11 |
| Control | Timed up and go Test | 8.20 seconds | Standard Deviation 1.43 |
Secondary
Unloaded Reach Test
Distance on an unloaded reach test (cm). Greater distance indicates better function.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Unloaded Reach Test | 36.2 cm | Standard Deviation 7.5 |
| Control | Unloaded Reach Test | 34.0 cm | Standard Deviation 4.9 |
Secondary
Work Productivity
Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Work Productivity | 6.57 points | Standard Deviation 0.72 |
| Control | Work Productivity | 6.61 points | Standard Deviation 0.88 |