EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
- Conditions
- Chronic Pain
- Interventions
- Behavioral: E-health program
- Registration Number
- NCT03308188
- Lead Sponsor
- University of Cincinnati
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E-Health+ E-health program 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.
- Primary Outcome Measures
Name Time Method Decrease in Morphine Equivalent Dose (MED) Baseline and 10 months Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
- Secondary Outcome Measures
Name Time Method Pain Intensity 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.
Trial Locations
- Locations (2)
Duke Health
🇺🇸Durham, North Carolina, United States
UC Health
🇺🇸Cincinnati, Ohio, United States