Epidemiology of Osteoarthritis (OA) Pain

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: NCT01557231
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : March 29, 2018
ZARS Pharma Inc.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

Brief Summary:
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 or disease

Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiology of OA Pain
Study Start Date : March 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

No treatment

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

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

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

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

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): NCT01557231

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

Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University Identifier: NCT01557231     History of Changes
Other Study ID Numbers: STU00059872
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Thomas J. Schnitzer, Northwestern University:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases