Amputation, Brain Injuries, Traumatic, Chronic Pain, Multiple Sclerosis, Spinal Cord Injuries
Conditions
Keywords
chronic pain, cognitive therapy, mindfulness meditation, activation skills, pain, employment, telehealth
Brief summary
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.
Detailed description
Chronic pain is one of the most prevalent, disabling, and persistent comorbid conditions associated with physical disabilities, including limb loss, spinal cord injury, traumatic brain injury, and chronic neurodegenerative conditions such as multiple sclerosis. One half to two-thirds of adults with these conditions experience chronic pain. In addition to being associated with disability, depression, sleep disruption, and physical inactivity, chronic pain has deleterious social and societal costs, including job loss and reliance on long-term disability programs. The E-TIPS intervention aims to address common barriers encountered by employed individuals with chronic pain. People with physical disabilities may be offered face-to-face delivery of pain self-management interventions, in clinical settings during business hours, which limits access to people with physical disabilities who are employed. These individuals must take time off work to attend multiple treatment sessions, overcome transportation difficulties, and contend with the stigma of seeking behavioral healthcare. Telehealth interventions, such as E-TIPS, have considerable potential for expanding the reach of pain self-management interventions for employed people with physical disabilities. The proposed randomized (1:1), single-blind parallel-group trial will compare the E-TIPS telehealth pain self-management intervention to a waitlist control in adults with physical disabilities and chronic pain who are employed. Outcomes will be assessed before randomization, mid-treatment (6 weeks post-randomization), post-treatment (10 weeks post-randomization; primary endpoint), and 6-month follow up (25 weeks post-randomization). Participants will be recruited from across the US, including at University of Washington (UW) and Shirley Ryan AbilityLab (SRALab).
Interventions
BEHAVIORALE-TIPS
Chronic pain self-management strategies for employed individuals with physical disabilities
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A randomized (1:1), single blind parallel-group trial comparing a telehealth pain self-management intervention, adapted to address employment issues (E-TIPS), to a waitlist control in adults with physical disabilities and chronic pain who are employed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Self-reported physical disability * Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale * Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater) * Reads, speaks, and understands English * Has access to and is able to communicate over the telephone with our without assistive devices * Is employed, working 15-20 hours per week or more, on average, or earning in excess of substantial gainful activity (approximately $1200/month) We will enroll individuals with a range of physical disabilities to maximize the generalizability of the results, because there is no evidence that the type of disability affects responsiveness to the proposed treatment
Exclusion criteria
* Under the age of 18 * Cannot read, speak, or understand English * No self-reported physical disability * Currently unemployed * Plans to retire or leave employment within the study period * Working fewer than 15-20 hours per week, on average, and earning less than approximately $1200 per month * Cannot communicate or complete assessments over the phone or internet * Chronic pain defined as daily pain of ≤ 3 months duration and ≤ 3 average pain intensity in the past week on a 0-10 numerical rating scale * Experiences pain for fewer than 45 out of the past 90 days (defined as 50% of the time or less) * Currently participating in another pain study or cognitive behavioral therapy (CBT) study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | Baseline (week 0) and 12 weeks (post-treatment) | Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater self-reported pain interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Self-efficacy | Baseline (week 0) and 12 weeks (post-treatment) | Patient-reported pain self-efficacy for managing pain using the University of Washington Pain Self-Efficacy Scale-6 item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score.The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater patient-reported self-efficacy for managing pain. |
| Change in Average Pain Intensity | Baseline (week 0) and 12 weeks (post-treatment) | 0-10 Numerical Pain Rating Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity; range of 0 - 10. |
Countries
United States
Participant flow
Pre-assignment details
Of the 220 enrolled participants, 8 were excluded prior to the baseline assessment because they were not able to be contacted for baseline completion. After 212 enrolled participants completed the baseline assessment, 10 additional participants were excluded because: we were unable to contact them for randomization (n=5), they withdrew from the study due to personal circumstances (n=3), or withdrawn by staff (n=2). A total of 202 were randomized to one of the two study arms.
Participants by arm
| Arm | Count |
|---|---|
| E-TIPS The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities | 102 |
| Usual Care Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment. | 100 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6-Month Follow Up | Lost to Follow-up | 9 | 8 |
| Post-Treatment | Lost to Follow-up | 6 | 5 |
Baseline characteristics
| Characteristic | E-TIPS | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 12 | 46 years STANDARD_DEVIATION 12 | 46 years STANDARD_DEVIATION 12 |
| Disability condition Amputation | 11 Participants | 7 Participants | 18 Participants |
| Disability condition Multiple diagnoses | 13 Participants | 13 Participants | 26 Participants |
| Disability condition Multiple sclerosis | 48 Participants | 48 Participants | 96 Participants |
| Disability condition Spinal cord injury | 17 Participants | 20 Participants | 37 Participants |
| Disability condition Traumatic brain injury | 13 Participants | 12 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 6 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 88 Participants | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 80 Participants | 71 Participants | 151 Participants |
| Region of Enrollment United States | 102 participants | 100 participants | 202 participants |
| Sex/Gender, Customized Female | 71 participants | 70 participants | 141 participants |
| Sex/Gender, Customized Male | 31 participants | 30 participants | 61 participants |
| Sex/Gender, Customized Man | 30 participants | 30 participants | 60 participants |
| Sex/Gender, Customized Non-binary | 2 participants | 2 participants | 4 participants |
| Sex/Gender, Customized Other | 0 participants | 1 participants | 1 participants |
| Sex/Gender, Customized Prefer not to answer/unknown | 1 participants | 2 participants | 3 participants |
| Sex/Gender, Customized Woman | 69 participants | 65 participants | 134 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 100 |
| other Total, other adverse events | 0 / 102 | 0 / 100 |
| serious Total, serious adverse events | 1 / 102 | 0 / 100 |
Outcome results
Primary
Change in Pain Interference
Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater self-reported pain interference.
Time frame: Baseline (week 0) and 12 weeks (post-treatment)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| E-TIPS | Change in Pain Interference | -4.0 T-score |
| Usual Care | Change in Pain Interference | -1.3 T-score |
p-value: 0.004Mixed Models Analysis
Secondary
Change in Average Pain Intensity
0-10 Numerical Pain Rating Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity; range of 0 - 10.
Time frame: Baseline (week 0) and 12 weeks (post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-TIPS | Change in Average Pain Intensity | -0.9 units on a scale | Standard Deviation 1.9 |
| Usual Care | Change in Average Pain Intensity | -0.3 units on a scale | Standard Deviation 1.7 |
p-value: 0.2995% CI: [-0.61, -0.03]Mixed Models Analysis
Secondary
Change in Pain Self-efficacy
Patient-reported pain self-efficacy for managing pain using the University of Washington Pain Self-Efficacy Scale-6 item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score.The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater patient-reported self-efficacy for managing pain.
Time frame: Baseline (week 0) and 12 weeks (post-treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-TIPS | Change in Pain Self-efficacy | 5.5 T-score | Standard Deviation 8.2 |
| Usual Care | Change in Pain Self-efficacy | 0.9 T-score | Standard Deviation 7.5 |
p-value: <0.00195% CI: [0.3, 0.88]Mixed Models Analysis