What side effects are associated with this type of intervention?

Common treatments for chronic pain, such as those used in the TPSP, generally have minimal physical side effects compared to pharmacological treatments. Pain education and e-mobile self-management tools primarily involve cognitive and behavioral strategies, which may lead to temporary increases in anxiety or frustration as patients adjust to new coping mechanisms. Acceptance and Commitment Therapy (ACT) can sometimes cause initial emotional discomfort as patients confront difficult thoughts and feelings. However, these side effects are typically short-lived and outweighed by the long-term benefits of improved pain management and psychological well-being.

What prior FDA approvals exist?

The FDA has approved various pharmacologic treatments for chronic pain, including opioids like buprenorphine and morphine, as well as non-opioid medications such as NSAIDs and antidepressants like SSRIs and SNRIs. Multidisciplinary approaches, similar to the TPSP, which incorporate pain education, Acceptance and Commitment Therapy (ACT), and e-mobile self-management tools, are increasingly recognized for their effectiveness in managing chronic pain. These comprehensive strategies aim to balance the benefits and risks of opioid use while promoting long-term health and well-being.

What other types of research exist?

Promising novel alternatives to the Transitional Pain Service Program (TPSP) for chronic pain patients include: 1) Self-managed behavioral exercise programs that utilize multidisciplinary team resources, 2) Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) enhanced with artificial intelligence and mobile health tools, 3) Physical therapy-based models focusing on pain mitigation and opioid tapering, and 4) Multidisciplinary biopsychosocial rehabilitation programs.

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Interventional Group for Chronic Pain (RECOUP Trial)

N/A

Recruiting

Led By Duminda Wijeysundera, 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

No Placebo-Only Group

Summary

This trial tests a program that helps surgery patients who use opioids manage their pain and reduce opioid use. The program includes education, therapy, and a mobile app. It aims to help patients understand and handle their pain better without needing opioids.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain interference

Portion of patients weaned off opioids

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for chronic pain, particularly those used in the Transitional Pain Service Program (TPSP), include pain education, Acceptance and Commitment Therapy (ACT), and e-mobile self-management tools. Pain education helps patients understand their pain, reducing fear and anxiety that can worsen pain. ACT promotes psychological flexibility, enabling patients to accept their pain and focus on their values, thus diminishing the emotional burden of pain. E-mobile self-management tools offer ongoing support and resources, empowering patients to manage their pain actively. These treatments are essential as they address both the physical and psychological dimensions of chronic pain, leading to more holistic and effective pain management.

The role of nonpharmacologic therapies in management of chronic pelvic pain: what to do when surgery fails.Acceptance and commitment therapy for chronic pain: evidence of mediation and clinically significant change following an abbreviated interdisciplinary program of rehabilitation.