Study Summary
This trial will compare a cognitive-behavioral pain self-management intervention delivered by telephone to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed.
Eligible Conditions
- Chronic Pain
- Traumatic Brain Injury
- Amputation
- Multiple Sclerosis
- Spinal Cord Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization
Week 25
Change in average pain intensity
Change in pain self-efficacy
Week 38
Change in pain interference
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual care
1 of 2
E-TIPS
1 of 2
Active Control
Experimental Treatment
200 Total Participants · 2 Treatment Groups
Primary Treatment: E-TIPS · No Placebo Group · N/A
E-TIPS
Behavioral
Experimental Group · 1 Intervention: E-TIPS · Intervention Types: BehavioralUsual careNoIntervention Group · 1 Intervention: Usual care · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,609 Previous Clinical Trials
1,572,670 Total Patients Enrolled
36 Trials studying Chronic Pain
16,967 Patients Enrolled for Chronic Pain
Department of Health and Human ServicesFED
204 Previous Clinical Trials
469,122 Total Patients Enrolled
Dawn M Ehde, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
195 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have reported having a physical disability.
People with different types of physical disabilities are welcome to participate in the study because there is no evidence that the type of disability affects how well the treatment works.
You are able to read, speak, and understand English.
You have been experiencing pain for at least three months, with an average intensity of at least 3 out of 10 on a pain scale.
You have been experiencing pain for more than 45 out of the last 90 days, which means you are in pain more than half of the time.
Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Krause, James S., Yue Cao, and Jillian M.R. Clark. 2017. “Pain Intensity, Interference, and Medication Use After Spinal Cord Injury: Association with Risk of Mortality After Controlling for Socioeconomic and Other Health Factors”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2017.05.024.
- Kroenke, Kurt, Jingwei Wu, Matthew J. Bair, Erin E. Krebs, Teresa M. Damush, and Wanzhu Tu. 2011. “Reciprocal Relationship Between Pain and Depression: A 12-month Longitudinal Analysis in Primary Care”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2011.03.003.
- O’Connor, Alec B., Steven R. Schwid, David N. Herrmann, John D. Markman, and Robert H. Dworkin. 2008. “Pain Associated with Multiple Sclerosis: Systematic Review and Proposed Classification”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.pain.2007.08.024.
- Beric, Aleksandar. 2003. “Spinal Cord Injury Pain”. European Journal of Pain. Wiley. doi:10.1016/s1090-3801(03)00045-4.
- Franklin, Gary M., Thomas M. Wickizer, Norma B. Coe, and Deborah Fulton-Kehoe. 2014. “Workers' Compensation: Poor Quality Health Care and the Growing Disability Problem in the United States”. American Journal of Industrial Medicine. Wiley. doi:10.1002/ajim.22399.
- Nègre-Pagès, Laurence, Wafa Regragui, Didier Bouhassira, Héléne Grandjean, Olivier Rascol, and on behalf of the DoPaMiP Study Group (Investigators listed at end of report). 2008. “Chronic Pain in Parkinson's Disease: The Cross-sectional French Dopamip Survey”. Movement Disorders. Wiley. doi:10.1002/mds.22142.
- Ehde, Dawn M., Mark P. Jensen, Joyce M. Engel, Judith A. Turner, Amy J. Hoffman, and Diana D. Cardenas. 2003. “Chronic Pain Secondary to Disability: A Review”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00002508-200301000-00002.
- Clarke, Greg, and Bobbi Jo Yarborough. 2013. “Evaluating the Promise of Health IT to Enhance/expand the Reach of Mental Health Services”. General Hospital Psychiatry. Elsevier BV. doi:10.1016/j.genhosppsych.2013.03.013.
- Warms, Catherine A., Judith A. Turner, Helen M. Marshall, and Diana D. Cardenas. 2002. “Treatments for Chronic Pain Associated with Spinal Cord Injuries: Many Are Tried, Few Are Helpful”. The Clinical Journal of Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00002508-200205000-00004.
- Ehde, Dawn M., Joseph M. Czerniecki, Douglas G. Smith, Kellye M. Campbell, W.Thomas Edwards, Mark P. Jensen, and Lawrence R. Robinson. 2000. “Chronic Phantom Sensations, Phantom Pain, Residual Limb Pain, and Other Regional Pain After Lower Limb Amputation”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1053/apmr.2000.7583.
- Alschuler, Kevin N., Dawn M. Ehde, and Mark P. Jensen. 2013. “The Co-occurrence of Pain and Depression in Adults with Multiple Sclerosis.”. Rehabilitation Psychology. American Psychological Association (APA). doi:10.1037/a0032008.
- Ehde, Dawn M., Tiara M. Dillworth, and Judith A. Turner. 2014. “Cognitive-behavioral Therapy for Individuals with Chronic Pain: Efficacy, Innovations, and Directions for Research.”. American Psychologist. American Psychological Association (APA). doi:10.1037/a0035747.
- 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.
- Social Security Administration. Annual Statistical Report on the Social Security Disability Insurance Program, 2015. Washington, DC2016.
- 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. doi: 10.1097/00002508-200301000-00002.
- Negre-Pages 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.
- 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.
- 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. doi: 10.1097/00002508-200205000-00004.
- 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. doi: 10.1053/apmr.2000.7583.
- 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.
- 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.
- Dawn Ehde 2020. "Telehealth Pain Self-Management for Employed Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04248725.
Frequently Asked Questions
How many participants are being recruited for this clinical experiment?
"Affirmative. Clinicaltrials.gov exhibits that this trial is actively enlisting patients, with the initial posting being on March 2nd 2020 and the most recent edit occurring July 25th 2022. The study seeks to recruit 200 participants from a single site." - Anonymous Online Contributor
Unverified Answer
Does this experimental research still accommodate participants?
"Clinicaltrials.gov states that this trial, initially posted on March 2nd 2020 and revised July 25th 2022, is actively recruiting participants." - Anonymous Online Contributor
Unverified Answer