EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications

NCT ID: NCT03308188

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2021-10-31

Brief Summary

This is a 10-month internet-based randomized controlled trial to evaluate whether an online chronic pain management program ("E-Health") can assist with reduced opioid reliance in chronic pain patients. About half of the eligible participants will receive access to the E-Health program in addition to their standard chronic pain treatment; the other half will just continue receiving their standard chronic pain treatment.

Detailed Description

This study will determine whether an innovative, accessible E-health intervention can assist with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of unintended opioid overdose and death. Importantly, the study will contribute to a better understanding of the mechanisms contributing to opioid use reduction while managing pain. The findings may assist in developing treatment options for a population at risk for opioid adverse effects.

Potential participants will be identified through electronic health record (EHR) queries at participating sites. Participants will be assessed at baseline, at the end of the 4-month treatment period, and at 6 months following end-of-treatment through an electronic data capture system accessed by the participants. Other outcome data will be obtained from the participant's EHR data.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment As Usual

Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

E-Health+

Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.

Group Type: EXPERIMENTAL

E-health program

Intervention Type: BEHAVIORAL

The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.

Interventions

E-health program

The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Be 25-80 years of age
• Be able to understand the study, and having understood, provide informed consent in English
• Have a daily average prescribed MED ≥ 20 mg over a recent three-month period
• Have a chronic pain-related diagnosis
• Self-report current use of opioid medication(s) to treat pain
• Have a Brief Pain Inventory Pain Intensity score ≥3
• Have internet access and a working email account

Exclusion Criteria

• Be anyone who, in the judgment of study staff, would be unlikely to complete the study (e.g., planning to change to a different primary care clinic, have a terminal illness, etc.)
• Be unwilling/unable to complete the WebNeuro assessments
• Be pregnant
• Be a prisoner

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

T. John Winhusen, PhD

Professor; Vice Chair and Division Director of Addiction Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Winhusen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

Duke Health

Durham, North Carolina, United States

UC Health

Cincinnati, Ohio, United States

Countries

United States

References

Wilson M, Dolor RJ, Lewis D, Regan SL, Vonder Meulen MB, Winhusen TJ. Opioid dose and pain effects of an online pain self-management program to augment usual care in adults with chronic pain: a multisite randomized clinical trial. Pain. 2023 Apr 1;164(4):877-885. doi: 10.1097/j.pain.0000000000002785. Epub 2022 Sep 15.

Reference Type: DERIVED

PMID: 36525381 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01DA044248-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-2301

Identifier Type: -

Identifier Source: org_study_id