Arthritis, Cognitive Impairment, Pain
Conditions
Keywords
Pain, Analgesia, Cognitive impairment, Randomized controlled trial, Physical function
Brief summary
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.
Interventions
DRUGlong acting oxycodone
10mg twice daily
DRUGextra strength acetaminophen
1,000 mg twice daily
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Self-report on the Brief Pain Inventory and WOMAC | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Discontinuation of Study Drug, Short Physical Performance Battery | 14 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Patients This study was initially designed as a randomized crossover trial comparing extra strength acetaminophen (1,000 mg twice daily) to long acting oxycodone (10 mg twice daily). Unfortunately the treatment group assignments were lost and therefore there is no information on which treatment sequence patients were assigned to. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | All Enrolled Patients |
|---|---|
| Age, Continuous | 79.4 years |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Pain Self-report on the Brief Pain Inventory and WOMAC
Time frame: 14 days
Population: No data are available for this outcome (study records were lost).
Secondary
Discontinuation of Study Drug, Short Physical Performance Battery
Time frame: 14 days
Population: No data are available for this outcome (study records were lost).