Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Cognitive Impairment; Arthritis; Pain

Treatments: Drug: long acting oxycodone; Drug: extra strength acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01264965

10-238-B

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

Acetaminophen

Active Comparator group

Treatment:

Drug: extra strength acetaminophen

Long Acting Oxycodone

Active Comparator group

Treatment:

Drug: long acting oxycodone