Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

Phase 4

Terminated

• Conditions: Cognitive Impairment; Arthritis; Pain
• Interventions: Drug: extra strength acetaminophen; Drug: long acting oxycodone

• Registration Number: NCT01264965
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Study Start: 2011-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2020-10-02
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Results First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acetaminophen	extra strength acetaminophen	-
Long Acting Oxycodone	long acting oxycodone	-

Primary Outcome Measures

Name	Time	Method
Pain Self-report on the Brief Pain Inventory and WOMAC	14 days

Secondary Outcome Measures

Name	Time	Method
Discontinuation of Study Drug, Short Physical Performance Battery	14 days

Trial Locations

Locations (1)

University of Chicago Medical Center Outpatient Senior Health Center South Shore; 🇺🇸 Chicago, Illinois, United States