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Completed

NCT Number: NCT03308188

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

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Health, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-health program

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.

Primary outcomes

  1. Decrease in Morphine Equivalent Dose (MED)

    Time frame: Baseline and 10 months

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

Secondary outcomes

  1. Pain Intensity

    Time frame: Baseline and 10 months

    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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

EMPOWER: Evaluating the Ability to Reduce Morphine Equivalent Dose for Chronic Pain Patients Receiving Opioid-therapy Through a Web-based E-Health Self-management Program: a Randomized Multi-site Clinical Trial in Primary Care

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2017
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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