Clinical trial · Interventional
Non-cancer Pain and Cognitive Impairment: A Disabling Relationship
Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment problems
Summary
Brief summary (as posted)
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| extra strength acetaminophen | Drug | — | UNRESOLVED |
| long acting oxycodone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Acetaminophen
- interventionNames
- Drug: extra strength acetaminophen
- type
- ACTIVE_COMPARATOR
- label
- Long Acting Oxycodone
- interventionNames
- Drug: long acting oxycodone
Primary outcomes (1)
- measure
- Pain Self-report on the Brief Pain Inventory and WOMAC
- timeFrame
- 14 days
Secondary outcomes (1)
- measure
- Discontinuation of Study Drug, Short Physical Performance Battery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. age over 65 2. Pain at least 3 months duration 3. Pain greater in lower extremity than other anatomical site with ambulation 4. Pain self-report of moderate intensity of higher on an average day 5. Community-dwelling 6. Ambulatory 7. Physician states participants have decision-making capacity to enroll into the trial 8. Participants with cognitive impairment have a reliable caregiver 9. Inadequate pain relief from NSAIDS and/or acetaminophen in the past Exclusion Criteria: 1. Current cancer requiring chemotherapy 2. History of addiction to opioids or other controlled substance 3. Consumes more than 2 alcoholic drinks a day 4. Severe balance disturbance 5. Intra-articular steroid injection in the past 6 weeks
References
Publications (0)
Data not yet available