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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

Primary Purpose

Arthritis, Pain, Cognitive Impairment

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
long acting oxycodone
extra strength acetaminophen
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Pain, Analgesia, Cognitive impairment, Randomized controlled trial, Physical function

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Chicago Medical Center Outpatient Senior Health Center South Shore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Acetaminophen

Long Acting Oxycodone

Arm Description

Outcomes

Primary Outcome Measures

Pain Self-report on the Brief Pain Inventory and WOMAC

Secondary Outcome Measures

Discontinuation of Study Drug, Short Physical Performance Battery

Full Information

First Posted
December 20, 2010
Last Updated
November 18, 2020
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01264965
Brief Title
Non-cancer Pain and Cognitive Impairment: A Disabling Relationship
Official Title
Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
recruitment problems
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Pain, Cognitive Impairment
Keywords
Pain, Analgesia, Cognitive impairment, Randomized controlled trial, Physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Title
Long Acting Oxycodone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
long acting oxycodone
Intervention Description
10mg twice daily
Intervention Type
Drug
Intervention Name(s)
extra strength acetaminophen
Intervention Description
1,000 mg twice daily
Primary Outcome Measure Information:
Title
Pain Self-report on the Brief Pain Inventory and WOMAC
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Discontinuation of Study Drug, Short Physical Performance Battery
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age over 65 Pain at least 3 months duration Pain greater in lower extremity than other anatomical site with ambulation Pain self-report of moderate intensity of higher on an average day Community-dwelling Ambulatory Physician states participants have decision-making capacity to enroll into the trial Participants with cognitive impairment have a reliable caregiver Inadequate pain relief from NSAIDS and/or acetaminophen in the past Exclusion Criteria: Current cancer requiring chemotherapy History of addiction to opioids or other controlled substance Consumes more than 2 alcoholic drinks a day Severe balance disturbance Intra-articular steroid injection in the past 6 weeks
Facility Information:
Facility Name
University of Chicago Medical Center Outpatient Senior Health Center South Shore
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60649
Country
United States

12. IPD Sharing Statement

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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

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