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Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264965
Recruitment Status : Terminated (recruitment problems)
First Posted : December 22, 2010
Last Update Posted : November 14, 2014
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acetaminophen Drug: extra strength acetaminophen
1,000 mg twice daily

Active Comparator: Long Acting Oxycodone Drug: long acting oxycodone
10mg twice daily

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264965

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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
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Responsible Party: University of Chicago Identifier: NCT01264965    
Other Study ID Numbers: 10-238-B
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by University of Chicago:
Cognitive impairment
Randomized controlled trial
Physical function
Additional relevant MeSH terms:
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Cognitive Dysfunction
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