Chronic Pain
Conditions
Brief summary
The objective of this pilot study to evaluate if behavioral incentives applied at the VA Medical Center can appreciably increase participation in activities that promote mobility, and subsequently reduce pain severity and opioid use.
Detailed description
Chronic pain is a highly prevalent and costly condition in the US. An estimated 88.5 million adults suffer from daily pain, resulting in estimated cost of $500- 635 biJlion due to lost productivity, and $261-300 billion in health care expenditures. To manage their chronic pain, 5 to 8 million Americans take an opioid medication daily. Yet , the risks associated with ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic effects. Opioids are not more effective in the treatment of chronic pain compared with non-opioid approaches. Current guidelines have adapted to the evidence, recommending opioid-sparing approaches for treating patients with chronic pain, and tapering for those on higher doses to safer levels of use. Tapering opioids, however, requires replacing them with effective non-opioid strategies. Improving mobility has been shown to improve pain and decrease medication use among patients chronically prescribed opiates. Concurrently, financial incentives and the use of behavioral incentives have been shown to promote mobility. Appreciating the gains in health outcomes that can be made with connected health approaches, we propose a novel pilot study designed to evaluate if technology enabled care (TEC) strategies and financial incentives can improve patient mobility in our chronic pain population, reduce pain and decrease opioid use . Our primary aim is to determine if chronic pain patients who receive TEC-enhanced treatment with financial incentives demonstrate increased participation in activities that promote mobility (physical therapy, yoga, tai chi) in comparison to patients receiving usual care. Secondary outcomes will include whether increased activity participation also reduces pain severity and opioid use, and improves function and increases the number of daily steps taken. The results of this pilot will enable us to determine what strategies are effective at increasing mobility and if these gains translate into reduced pain and decreased opioid use.
Interventions
BEHAVIORALRegret lottery
Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
BEHAVIORALWay to Health technology enhanced care
Subjects receive text reminders to reach activity goals.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic non-malignant pain * High dose opioid therapy * Possession of activated cell phone with text messaging capabilities * Willingness to comply with study requirements
Exclusion criteria
* Pain of malignant origin * Sensory impairments precluding use of text messaging and activity tracker * Physical disability precluding improvements in physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity Participation | 12 weeks | Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome |
| Increased Mobility | 12 weeks | steps per day measured by wearable step tracker at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Opioid Use | 12 weeks | measured by opioid morphine mg equivalents used each day (MED) |
| Physical Function | 12 weeks | measured by interference with walking on PROMIS (Patient-reported Outcomes Measurement Information System) pain interference tool, which is a 6-item self-report survey; each item is scored from 1 (not at all) to 5 (very much), thus scores ranged from 6 to 30, with higher score indicating more pain interference. |
| Pain Severity | 12 weeks | measured by pain severity on PROMIS (Patient-reported Outcomes Measurement Information System) pain severity tool, which is a 3-item self-report survey; each item is scored from 1 (no pain at all) to 5 (very severity), thus scores ranged from 3 to 15, with higher score indicating more severe pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participate in technology-enabled care without regret lottery
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. | 20 |
| Experimental Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Experimental |
|---|---|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 11 | 57.4 years STANDARD_DEVIATION 12.3 | 59.6 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 35 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 15 Participants | 7 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 | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 22 Participants | 12 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 19 Participants | 37 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Activity Participation
Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Activity Participation | 156.0 score on a scale | Standard Deviation 116.8 |
| Experimental | Activity Participation | 135.8 score on a scale | Standard Deviation 123 |
p-value: =0.9ANCOVA
Primary
Increased Mobility
steps per day measured by wearable step tracker at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Increased Mobility | 4313 steps per day | Standard Deviation 4231 |
| Experimental | Increased Mobility | 4075 steps per day | Standard Deviation 5598 |
p-value: =0.88ANCOVA
Secondary
Daily Opioid Use
measured by opioid morphine mg equivalents used each day (MED)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Daily Opioid Use | 167.2 morphine mg equivalents per day (MED) | Standard Deviation 244.4 |
| Experimental | Daily Opioid Use | 31.9 morphine mg equivalents per day (MED) | Standard Deviation 35.53 |
p-value: <0.17ANCOVA
Secondary
Pain Severity
measured by pain severity on PROMIS (Patient-reported Outcomes Measurement Information System) pain severity tool, which is a 3-item self-report survey; each item is scored from 1 (no pain at all) to 5 (very severity), thus scores ranged from 3 to 15, with higher score indicating more severe pain.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain Severity | 6.7 units on a scale | Standard Deviation 1.63 |
| Experimental | Pain Severity | 6.8 units on a scale | Standard Deviation 1.95 |
p-value: =0.81ANCOVA
Secondary
Physical Function
measured by interference with walking on PROMIS (Patient-reported Outcomes Measurement Information System) pain interference tool, which is a 6-item self-report survey; each item is scored from 1 (not at all) to 5 (very much), thus scores ranged from 6 to 30, with higher score indicating more pain interference.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Function | 25.4 units on a scale | Standard Deviation 10.94 |
| Experimental | Physical Function | 24.2 units on a scale | Standard Deviation 12.49 |
p-value: <0.05ANCOVA