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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

This study has been terminated.
(recruitment problems)
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: December 20, 2010
Last updated: November 12, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Arthritis Pain Cognitive Impairment Drug: long acting oxycodone Drug: extra strength acetaminophen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • pain self-report on the brief pain inventory and WOMAC [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • discontinuation of study drug, short physical performance battery [ Time Frame: 14 days ]

Enrollment: 25
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acetaminophen Drug: extra strength acetaminophen
1,000 mg twice daily
Active Comparator: Long Acting Oxycodone Drug: long acting oxycodone
10mg twice daily


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01264965

United States, Illinois
University of Chicago Medical Center Outpatient Senior Health Center South Shore
Chicago, Illinois, United States, 60649
Sponsors and Collaborators
University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT01264965     History of Changes
Other Study ID Numbers: 10-238-B
Study First Received: December 20, 2010
Last Updated: November 12, 2014

Keywords provided by University of Chicago:
Cognitive impairment
Randomized controlled trial
Physical function

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants processed this record on September 21, 2017