Study Summary
This trial is testing a new program to help patients with chronic pain manage their pain and wean off opioids. The program includes pain education, Acceptance and Commitment Therapy, and an e-mobile self-management tool.
Eligible Conditions
- Chronic Pain
- Opioid Addiction
- Opioid Use Disorder
- Postoperative Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 1 year
1 year
Portion of patients weaned off opioids
One year
Pain interference
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control Group
1 of 2
Interventional Group
1 of 2
Active Control
Experimental Treatment
210 Total Participants · 2 Treatment Groups
Primary Treatment: Interventional Group · No Placebo Group · N/A
Interventional Group
Other
Experimental Group · 1 Intervention: Interventional Group · Intervention Types: OtherControl Group
Other
ActiveComparator Group · 1 Intervention: Control Intervention · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,380 Previous Clinical Trials
473,229 Total Patients Enrolled
10 Trials studying Chronic Pain
11,693 Patients Enrolled for Chronic Pain
Paul Tumber, MDPrincipal InvestigatorUniversity Health Network, Toronto
Duminda Wijeysundera, MDPrincipal InvestigatorUnity Health Toronto
1 Previous Clinical Trials
165 Total Patients Enrolled
Hance Clarke, MD, PhDPrincipal InvestigatorToronto General Hospital, University Health Network
4 Previous Clinical Trials
2,213 Total Patients Enrolled
2 Trials studying Chronic Pain
121 Patients Enrolled for Chronic Pain
Yuvaraj Kotteeswaran, MDPrincipal InvestigatorThunder Bay Reginal Health Sciences Centre
Anton Marinov, MDPrincipal InvestigatorRouge Valley Medical Centre
Melanie Toman, MDPrincipal InvestigatorThunder Bay Reginal Health Sciences Centre
Karim Ladha, MDPrincipal InvestigatorToronto General Hospital, University Health Network
1 Previous Clinical Trials
10 Total Patients Enrolled
Elaheh Adly, MDPrincipal InvestigatorHamilton Health Sciences Centre
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have undergone any type of surgical procedure, with the exception of those with palliative intent or organ transplantation.
You are taking opioids for at least one month prior to your operation.
Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Toronto General Hospital- University Health Network | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Most responsive sites:
- Toronto General Hospital- University Health Network: < 24 hours
Average response time
- < 1 Day
Typically responds via
| Phone Call | 100.0% |
References
- Katz, Joel, Aliza Weinrib, Samantha Fashler, Rita Katznelson, Bansi Shah, Salima Ladak, Jiao Jiang, et al.. 2015. “The Toronto General Hospital Transitional Pain Service: Development and Implementation of a Multidisciplinary Program to Prevent Chronic Postsurgical Pain”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s91924.
- Rampakakis, Emmanouil, Peter A Ste-Marie, John S Sampalis, Angeliki Karellis, Yoram Shir, and Mary-Ann Fitzcharles. 2015. “Real-life Assessment of the Validity of Patient Global Impression of Change in Fibromyalgia”. RMD Open. BMJ. doi:10.1136/rmdopen-2015-000146.
- Wicksell, Rikard K., Jonas Renöfält, Gunnar L. Olsson, Frank W. Bond, and Lennart Melin. 2008. “Avoidance and Cognitive Fusion - Central Components in Pain Related Disability? Development and Preliminary Validation of the Psychological Inflexibility in Pain Scale (PIPS)”. European Journal of Pain. Wiley. doi:10.1016/j.ejpain.2007.08.003.
- Clarke, H., N. Soneji, D. T. Ko, L. Yun, and D. N. Wijeysundera. 2014. “Rates and Risk Factors for Prolonged Opioid Use After Major Surgery: Population Based Cohort Study”. Bmj. BMJ. doi:10.1136/bmj.g1251.
- Darnall, Beth D., John A. Sturgeon, Karon F. Cook, Chloe J. Taub, Anuradha Roy, John W. Burns, Michael Sullivan, and Sean C. Mackey. 2017. “Development and Validation of a Daily Pain Catastrophizing Scale”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2017.05.003.
- Chapman, Stanley L., Robert N. Jamison, and Steven H. Sanders. 1996. “Treatment Helpfulness Questionnaire: A Measure of Patient Satisfaction with Treatment Modalities Provided in Chronic Pain Management Programs”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0304-3959(96)03217-4.
- Chou, Roger, Judith A. Turner, Emily B. Devine, Ryan N. Hansen, Sean D. Sullivan, Ian Blazina, Tracy Dana, Christina Bougatsos, and Richard A. Deyo. 2015. “The Effectiveness and Risks of Long-term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m14-2559.
- Katz, Joel, and Ze’ev Seltzer. 2009. “Transition from Acute to Chronic Postsurgical Pain: Risk Factors and Protective Factors”. Expert Review of Neurotherapeutics. Informa UK Limited. doi:10.1586/ern.09.20.
- Fletcher, D., and V. Martinez. 2014. “Opioid-induced Hyperalgesia in Patients After Surgery: A Systematic Review and a Meta-analysis”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aeu137.
- Tan, Gabriel, Mark P. Jensen, John I. Thornby, and Bilal F. Shanti. 2004. “Validation of the Brief Pain Inventory for Chronic Nonmalignant Pain”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2003.12.005.
- Portenoy, Russell, and for the ID Pain Steering Committee. 2006. “Development and Testing of a Neuropathic Pain Screening Questionnaire: ID Pain”. Current Medical Research and Opinion. Informa Healthcare. doi:10.1185/030079906x115702.
- Weinrib, Aliza, Lindsay Burns, Alex Mu, Muhammad Abid Azam, Salima s J Ladak, Karen McRae, Rita Katznelson, et al.. 2017. “A Case Report on the Treatment of Complex Chronic Pain and Opioid Dependence by a Multidisciplinary Transitional Pain Service Using the ACT Matrix and Buprenorphine/naloxone”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s124566.
- Savage, Seddon R.. 1996. “Long-term Opioid Therapy: Assessment of Consequences and Risks”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/0885-3924(95)00202-2.
- Angst, Martin S., and J David Clark. 2006. “Opioid-induced Hyperalgesia”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000542-200603000-00025.
- Sun, Eric C, Anjali Dixit, Keith Humphreys, Beth D Darnall, Laurence C Baker, and Sean Mackey. 2017. “Association Between Concurrent Use of Prescription Opioids and Benzodiazepines and Overdose: Retrospective Analysis”. Bmj. BMJ. doi:10.1136/bmj.j760.
- Dworkin, Robert H., Dennis C. Turk, Kathleen W. Wyrwich, Dorcas Beaton, Charles S. Cleeland, John T. Farrar, Jennifer A. Haythornthwaite, et al.. 2008. “Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2007.09.005.
- Löwe, Bernd, Inka Wahl, Matthias Rose, Carsten Spitzer, Heide Glaesmer, Katja Wingenfeld, Antonius Schneider, and Elmar Brähler. 2010. “A 4-item Measure of Depression and Anxiety: Validation and Standardization of the Patient Health Questionnaire-4 (PHQ-4) in the General Population”. Journal of Affective Disorders. Elsevier BV. doi:10.1016/j.jad.2009.06.019.
- Angst, Martin S., and J David Clark. 2006. “Opioid-induced Hyperalgesia”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000542-200603000-00025.
- Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
- Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015. Erratum In: RMD Open. 2015;1(1):e000146corr1.
- Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
- Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
- Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
- Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.
- Wicksell RK, Renofalt J, Olsson GL, Bond FW, Melin L. Avoidance and cognitive fusion--central components in pain related disability? Development and preliminary validation of the Psychological Inflexibility in Pain Scale (PIPS). Eur J Pain. 2008 May;12(4):491-500. doi: 10.1016/j.ejpain.2007.08.003. Epub 2007 Sep 20.
- Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
- Chapman SL, Jamison RN, Sanders SH. Treatment Helpfulness Questionnaire: a measure of patient satisfaction with treatment modalities provided in chronic pain management programs. Pain. 1996 Dec;68(2-3):349-61. doi: 10.1016/s0304-3959(96)03217-4.
- Portenoy R. Development and testing of a neuropathic pain screening questionnaire: ID Pain. Curr Med Res Opin. 2006 Aug;22(8):1555-65. doi: 10.1185/030079906X115702.
- Savage SR. Long-term opioid therapy: assessment of consequences and risks. J Pain Symptom Manage. 1996 May;11(5):274-86. doi: 10.1016/0885-3924(95)00202-2.
- Lowe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brahler E. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010 Apr;122(1-2):86-95. doi: 10.1016/j.jad.2009.06.019. Epub 2009 Jul 17.
- 2018. "Reducing Opioid Use for Chronic Pain Patients Following Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03675386.
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