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Interventional Group for Chronic Pain (RECOUP Trial)

N/A

Recruiting

Led By Elaheh Adly, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

RECOUP Trial 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.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, interventions like ACT may cause emotional discomfort initially. The e-mobile tool has no direct side effects but could lead to frustration if technical issues arise.

RECOUP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain interference

Portion of patients weaned off opioids

RECOUP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional GroupExperimental Treatment1 Intervention

Patients in the interventional group will be given a Transitional Pain Service follow-up appointment at the following postoperative time points (2 to 6 visits for the first two months, and then 1 to 2 visits on a monthly basis until one year). At each visit, patients will meet with the clinical psychologist and chronic pain specialist. Patients in the intervention group will have access to the Manage My Pain (MMP) App. which allows people living with pain to quickly and easily track their pain and function on a daily basis on their smartphones or a browser on their desktop or mobile device. One-page clinical reports will capture the changes in patients' outcome data between clinical visits over the course in time.Clinic visits can be offered in person at the hospital or over telehealth (video conference) based on the patient's preference and clinician's judgment for telehealth suitability.

Group II: Control GroupActive Control1 Intervention

Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,794 Total Patients Enrolled

12 Trials studying Chronic Pain

12,338 Patients Enrolled for Chronic Pain

Elaheh Adly, MDPrincipal InvestigatorHamilton Health Sciences Centre

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being examined within the parameters of this clinical research?

"Affirmative, the info posted on clinicaltrials.gov demonstrates that this experiment is currently recruiting participants. It was published online on September 24th 2018 and updated most recently in March 10th 2022. This analysis requires 210 individuals from one medical centre to participate."

Answered by AI

Is this experiment currently seeking participants?

"According to clinicaltrials.gov, the recruitment efforts for this trial are still ongoing; initially posted on September 24th 2018 and recently revised on March 10th 2022."

Answered by AI