Phase 2 Completed N=820 Randomized Single-blind Treatment

Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

Postoperative Pain

Source: ClinicalTrials.gov NCT03026790 ↗

Enrolled (actual)

820

Serious AEs

30.2%

Results posted

Jun 2023

Primary outcomePrimary: Pain Response — 58; 54 Participants

Summary

Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Response	58; 54	—
SECONDARY 50% Reduction in Opioid Daily Dose	102; 98	—
SECONDARY Composite Response	17; 17	—
SECONDARY Brief Pain Inventory (BPI) Total Score	6.07; 6.01	—

Eligibility Criteria

Inclusion Criteria

Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain
Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)

Exclusion Criteria

Dementia diagnosis
Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
Documentation of suspected controlled substance diversion
Inability to communicate by telephone

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03026790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.