Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

Pain Clinical Trial

Official title:

Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01264965
• Other study ID #: 10-238-B
• Status: Terminated
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: November 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Cognitive Dysfunction
• Cognitive Impairment
• Pain

Intervention

Drug:
• long acting oxycodone
10mg twice daily
• extra strength acetaminophen
1,000 mg twice daily

Locations

Country	Name	City	State
United States	University of Chicago Medical Center Outpatient Senior Health Center South Shore	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Self-report on the Brief Pain Inventory and WOMAC		14 days
Secondary	Discontinuation of Study Drug, Short Physical Performance Battery		14 days