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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

NCT ID: NCT01264965

Last Updated: 2020-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Arthritis Pain Cognitive Impairment

Keywords

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Pain Analgesia Cognitive impairment Randomized controlled trial Physical function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acetaminophen

Group Type ACTIVE_COMPARATOR

extra strength acetaminophen

Intervention Type DRUG

1,000 mg twice daily

Long Acting Oxycodone

Group Type ACTIVE_COMPARATOR

long acting oxycodone

Intervention Type DRUG

10mg twice daily

Interventions

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long acting oxycodone

10mg twice daily

Intervention Type DRUG

extra strength acetaminophen

1,000 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago Medical Center Outpatient Senior Health Center South Shore

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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10-238-B

Identifier Type: -

Identifier Source: org_study_id