Telehealth Pain Self-Management for Employed Adults

Multiple Sclerosis Clinical Trial

— E-TIPS  

Official title:

Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248725
• Other study ID #: STUDY00005686
• Secondary ID: 7258
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2022
• Source: University of Washington
• Contact: Carolyn C Green
• Phone: 206-616-9801
• Email: tipsstudy[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Pain
• Multiple Sclerosis
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• E-TIPS
Chronic pain self-management strategies for employed individuals with physical disabilities

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (14)

Alschuler KN, Ehde DM, Jensen MP. The co-occurrence of pain and depression in adults with multiple sclerosis. Rehabil Psychol. 2013 May;58(2):217-21. doi: 10.1037/a0032008. — View Citation

Anand P, Ben-Shalom Y. The promise of better economic outcomes for workers with musculoskeletal conditions. Roosevelt House: Public Policy Institute at Hunter College.2017.

Clarke G, Yarborough BJ. Evaluating the promise of health IT to enhance/expand the reach of mental health services. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):339-44. doi: 10.1016/j.genhosppsych.2013.03.013. Epub 2013 May 20. Review. — View Citation

Dijkers M, Bryce T, Zanca J. Prevalence of chronic pain after traumatic spinal cord injury: a systematic review. J Rehabil Res Dev. 2009;46(1):13-29. — View Citation

Ehde DM, Czerniecki JM, Smith DG, Campbell KM, Edwards WT, Jensen MP, Robinson LR. Chronic phantom sensations, phantom pain, residual limb pain, and other regional pain after lower limb amputation. Arch Phys Med Rehabil. 2000 Aug;81(8):1039-44. — View Citation

Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Am Psychol. 2014 Feb-Mar;69(2):153-66. doi: 10.1037/a0035747. Review. — View Citation

Ehde DM, Jensen MP, Engel JM, Turner JA, Hoffman AJ, Cardenas DD. Chronic pain secondary to disability: a review. Clin J Pain. 2003 Jan-Feb;19(1):3-17. Review. — View Citation

Franklin GM, Wickizer TM, Coe NB, Fulton-Kehoe D. Workers' compensation: poor quality health care and the growing disability problem in the United States. Am J Ind Med. 2015 Mar;58(3):245-51. doi: 10.1002/ajim.22399. Epub 2014 Oct 20. — View Citation

Krause JS, Cao Y, Clark JMR. Pain Intensity, Interference, and Medication Use After Spinal Cord Injury: Association With Risk of Mortality After Controlling for Socioeconomic and Other Health Factors. Arch Phys Med Rehabil. 2017 Dec;98(12):2464-2470. doi: 10.1016/j.apmr.2017.05.024. Epub 2017 Jun 23. — View Citation

Kroenke K, Wu J, Bair MJ, Krebs EE, Damush TM, Tu W. Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain. 2011 Sep;12(9):964-73. doi: 10.1016/j.jpain.2011.03.003. Epub 2011 Jun 16. — View Citation

Nègre-Pagès L, Regragui W, Bouhassira D, Grandjean H, Rascol O; DoPaMiP Study Group. Chronic pain in Parkinson's disease: the cross-sectional French DoPaMiP survey. Mov Disord. 2008 Jul 30;23(10):1361-9. doi: 10.1002/mds.22142. — View Citation

O'Connor AB, Schwid SR, Herrmann DN, Markman JD, Dworkin RH. Pain associated with multiple sclerosis: systematic review and proposed classification. Pain. 2008 Jul;137(1):96-111. doi: 10.1016/j.pain.2007.08.024. Epub 2007 Oct 24. Review. — View Citation

Social Security Administration. Annual Statistical Report on the Social Security Disability Insurance Program, 2015. Washington, DC2016.

Warms CA, Turner JA, Marshall HM, Cardenas DD. Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful. Clin J Pain. 2002 May-Jun;18(3):154-63. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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. Higher scores indicate greater self-reported pain interference.	Baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization
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. Higher scores indicate greater patient-reported self-efficacy for managing pain.	Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization
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.	Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization