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Epidemiology of Osteoarthritis (OA) Pain

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557231
First Posted: March 19, 2012
Last Update Posted: December 19, 2016
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.
Collaborator:
ZARS Pharma Inc.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
  Purpose
Chronic pain, by definition, persists over long periods of time, but both sufferers of pain and their caregivers are aware that pain levels can fluctuate greatly over time. Being able to define pain variability and its underlying causes would be an important advance in our understanding of chronic pain, and would in turn lead to better approaches to the treatment of chronic pain. In this study, the investigators propose to evaluate in 60 people with chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding magnitude of pain, physical activity level, and medication status twice daily during this period of time. The investigators then will assess the variability in pain levels over time, the frequency of "flares" of osteoarthritis (OA) pain and their relationship to physical activity, medications, and clinical descriptors of the population, e.g., age, gender, body mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA knee pain as well as assessment of subgroups of patients with the overall group being studied.

Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of OA Pain

Resource links provided by NLM:


Further study details as provided by Thomas J. Schnitzer, Northwestern University:

Primary Outcome Measures:
  • pain magnitude [ Time Frame: 6 months ]
    magnitude of pain will be evaluated 3x/day


Secondary Outcome Measures:
  • self-reported activity level [ Time Frame: 6 months ]
    data will be collected 3x/day; Likert 1-5 scale


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
OA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with OA
Criteria

Inclusion Criteria:

  1. Men and women, age 40 years and above
  2. Knee pain most days of the week for the past month
  3. Diagnosis of knee OA
  4. Meet ACR criteria for knee OA
  5. No significant limitations in physical activity
  6. Own and able to use a cellular phone capable of text messaging
  7. Able to return for all clinic visits
  8. Able to read and understand the informed consent document

Exclusion Criteria:

  1. Use of a walker to ambulate or inability to ambulate (use of cane is allowed)
  2. Other forms of arthritis
  3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
  4. Scheduled for and likely to need joint replacement surgery in the next 3 months
  5. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
  6. Living in a long-term care facility
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01557231


Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
ZARS Pharma Inc.
  More Information

Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01557231     History of Changes
Other Study ID Numbers: STU00059872
First Submitted: March 14, 2012
First Posted: March 19, 2012
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Thomas J. Schnitzer, Northwestern University:
OA
osteoarthritis
pain
variability
activity
treatment

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases