210 Participants NeededMy employer runs this trial

Program for Reducing Opioid Use in Chronic Pain

(RECOUP Trial)

HC
KL
Overseen ByKarim Ladha, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with chronic pain reduce their opioid use after surgery. The study tests the Transitional Pain Service Program (TPSP), which includes pain education, therapy, and a mobile app for managing pain. The goal is to find a safer way to handle pain and improve long-term health. Individuals who have used opioids for at least a month before surgery and can use the app might be suitable candidates for this trial.

As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies and potentially improve participants' quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on helping you reduce opioid use. If you're taking Methadone or Buprenorphine, you cannot participate in the trial.

What prior data suggests that the Transitional Pain Service Program (TPSP) is safe for managing chronic pain?

Previous studies have shown that the Transitional Pain Service Program (TPSP) reduces opioid use after surgery. Research indicates that this program helps patients manage pain more effectively and decrease their opioid dependence. Early data suggests that TPSP is well-tolerated, with no major side effects reported. Participants experienced a better quality of recovery, feeling better overall after surgery. This suggests the program is a safe and effective option for managing pain without heavy reliance on opioids.12345

Why are researchers excited about this trial?

Researchers are excited about the Transitional Pain Service Program (TPSP) because it offers a comprehensive, personalized approach to reducing opioid use in chronic pain patients after surgery. Unlike standard care, which typically involves follow-up with a surgeon and general pain management information, TPSP includes tailored follow-up appointments with a clinical psychologist and chronic pain specialist. This program also leverages technology through the Manage My Pain App, enabling patients to track their pain daily and receive detailed reports to guide their treatment. By integrating personalized care and technology, TPSP aims to empower patients to manage pain more effectively and potentially reduce reliance on opioids.

What evidence suggests that the Transitional Pain Service Program (TPSP) is effective for managing chronic pain?

Research has shown that the Transitional Pain Service Program (TPSP), available to participants in this trial, can significantly reduce opioid use after surgery. Studies have found that TPSP effectively links immediate post-surgery care with long-term recovery. The program combines pain education, therapy, and self-care tools. Evidence suggests it improves pain management and aids in safely reducing opioid use. In some cases, it even leads to better long-term outcomes by lowering the risk of persistent pain after surgery.13467

Who Is on the Research Team?

HC

Hance Clarke, MD, PhD

Principal Investigator

Toronto General Hospital, University Health Network

KL

Karim Ladha, MD

Principal Investigator

Toronto General Hospital, University Health Network

EA

Elaheh Adly, MD

Principal Investigator

Hamilton Health Sciences Centre

PT

Paul Tumber, MD

Principal Investigator

University Health Network, Toronto

MT

Melanie Toman, MD

Principal Investigator

Thunder Bay Reginal Health Sciences Centre

AM

Anton Marinov, MD

Principal Investigator

Rouge Valley Medical Centre

DW

Duminda Wijeysundera, MD

Principal Investigator

Unity Health Toronto

YK

Yuvaraj Kotteeswaran, MD

Principal Investigator

Thunder Bay Reginal Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been using opioids for chronic pain at doses of 20-200 mg oral morphine equivalents daily for at least a month before surgery. Participants must understand English, not be in palliative care or organ transplantation, and not use Methadone/Buprenorphine.

Inclusion Criteria

I am taking 20 to 200 mg of morphine or its equivalent daily before surgery.
Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool
Able to read and understand English as posed on the questionnaire surveys prior to informed consent
See 2 more

Exclusion Criteria

I am not receiving palliative care, organ transplantation, or taking Methadone/Buprenorphine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Transitional Pain Service Program (TPSP) intervention, including pain education, Acceptance and Commitment Therapy (ACT), and use of the Manage My Pain (MMP) App.

1 year
2 to 6 visits for the first two months, then 1 to 2 visits monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment, with an option to join the TPSP if still on opioids

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Transitional Pain Service Program (TPSP)

Trial Overview

The study tests the Transitional Pain Service Program (TPSP) which includes pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile tool to manage chronic pain post-surgery. The goal is to reduce opioid dependency while managing pain effectively.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Interventional GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Transitional Pain Services and Clinics: A Scoping Review of ...

Multiple lines of evidence suggest that such TPS/Cs models can significantly improve pain outcomes and facilitate successful opioid tapering. As ...

Transitional Pain Services: Closing the Gap Between Acute ...

Patients with CPSP use a disproportionate amount of healthcare resources, driving up costs and potentially leading to poor quality of life.

Transitional Pain Service: An Update - PMC - NIH

In most of these studies, the main outcome measured was the reduction in postoperative opioid use in surgical patients. In one of the first such ...

Transitional Pain Services and Clinics: A Scoping Review ...

Mostly, retrospective literature suggests that TPS/Cs can effectively bridge acute postoperative pain management with sustained long-term care, particularly for ...

The effectiveness of a transitional pain service in patients ...

Conclusions: TPS did not significantly affect short-term quality of recovery but might improve long-term outcomes , such as the incidence of ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38248732/

Patient Experiences and Clinical Outcomes in a ...

Siloed pain management across the perioperative period increases the risk of chronic opioid use and impedes postoperative recovery.

Patient Experiences and Clinical Outcomes in a ...

The objective of this study was to examine patients' experiences with and quality of recovery after participation in a TPS.