NCT03308188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3.7 years

First QC Date

October 6, 2017

Results QC Date

August 9, 2023

Last Update Submit

September 26, 2023

Conditions

Chronic Pain

Keywords

Opioid therapyweb-based interventionself-management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 10 months

Secondary Outcomes (1)

  • Pain Intensity

    Baseline and 10 months

Study Arms (2)

Treatment As Usual

NO INTERVENTION

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.

E-Health+

EXPERIMENTAL

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.

Behavioral: E-health program

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.

E-Health+

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke Health

Durham, North Carolina, 27710, United States

Location

UC Health

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • 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.

    PMID: 36525381DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
T. John Winhusen, PhD.
Organization
University of Cincinnati
winhust@ucmail.uc.edu
513-585-8292

Study Officials

  • Theresa Winhusen, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Vice Chair and Division Director of Addiction Sciences

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 12, 2017

Study Start

February 5, 2018

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-09

Locations

US(2)