NCT03308188

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

Completed NA Results posted Last updated 28 September 2023

What this trial tests

NA trial testing E-health program in Chronic Pain in 402 participants. Completed in 31 October 2021.

Timeline

5 February 2018

Primary endpoint
31 October 2021

31 October 2021

Quick facts

Lead sponsor	University of Cincinnati
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	402
Start date	5 February 2018
Primary completion	31 October 2021
Estimated completion	31 October 2021
Sites	2 locations across United States

Drugs / interventions tested

• E-health program

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of Cincinnati

Who can join

Adults 25 to 80, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Decrease in Morphine Equivalent Dose (MED) Primary · Baseline and 10 months

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

Group	Value	95% CI
Treatment As Usual	85
E-Health+	105

Pain Intensity Secondary · 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.

Group	Value	95% CI
Treatment As Usual	13
E-Health+	24

Adverse events — posted to ClinicalTrials.gov

Time frame: Randomization through Month 10. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment As Usual

Serious: 0/202 (0%)

Deaths: 0/202

E-Health+

Serious: 0/200 (0%)

Deaths: 1/200

Other adverse events (5 terms — click to expand)

Reaction	System	Treatment As Usual	E-Health+
Worsening of Anxiety	Psychiatric disorders	—	—
Worsening of Depression	Psychiatric disorders	—	—
Worsening of Pain Interference	General disorders	—	—
Worsening of Stress	Psychiatric disorders	—	—
Worsening of Pain Intensity	General disorders	—	—

Data from ClinicalTrials.gov NCT03308188 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.
   Darnall BD, Mackey SC, Lorig K, Kao MC, et al · · 2020 · cited 32× · PMID 31876947 · DOI 10.1093/pm/pnz285
2. 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.
   Wilson M, Dolor RJ, Lewis D, Regan SL, et al · · 2023 · cited 11× · PMID 36525381 · DOI 10.1097/j.pain.0000000000002785
3. A scoping review of outpatient interventions to support the reduction of prescription opioid medication for chronic non cancer pain.
   Nickerson K, Lieschke G, Rajappa H, Smith A, et al · · 2022 · cited 6× · PMID 35132707 · DOI 10.1111/jocn.16235
4. Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.
   Winhusen T, Wilson M, Dolor RJ, Theobald J, et al · · 2021 · cited 5× · PMID 33309947 · DOI 10.1016/j.cct.2020.106245
5. Neurocognitive predictors of adherence to an online pain self-management program adjunct to long-term opioid therapy.
   Fleck DE, Wilson M, Lewis D, Welge JA, et al · · 2023 · cited 3× · PMID 37278690 · DOI 10.1080/13803395.2023.2221396