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

University of Cincinnati402 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

402

Conditions

Chronic Pain

Interventions

E-health programBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Duke Health

Durham, North Carolina, United States

UC Health

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Decrease in Morphine Equivalent Dose (MED)

Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.

Time frame: Baseline and 10 months

Secondary Outcomes

Pain Intensity

Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up.

Time frame: Baseline and 10 months

Data from ClinicalTrials.gov

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