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Epidemiology of Osteoarthritis (OA) Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Collaborator:
ZARS Pharma Inc.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01557231
First received: March 14, 2012
Last updated: September 19, 2014
Last verified: September 2014
  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 Northwestern University:

Primary Outcome Measures:
  • pain magnitude [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    magnitude of pain will be evaluated 3x/day


Secondary Outcome Measures:
  • self-reported activity level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    data will be collected 3x/day; Likert 1-5 scale


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
OA

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557231

Contacts
Contact: Thomas Schnitzer, MD, PhD 3125032315 tjs@northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Thomas Schnitzer, MD, PhD    312-503-2315    tjs@northwestern.edu   
Principal Investigator: Thomas Schnitzer, MD, Phd         
Sponsors and Collaborators
Northwestern University
ZARS Pharma Inc.
  More Information

No publications provided

Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01557231     History of Changes
Other Study ID Numbers: STU00059872
Study First Received: March 14, 2012
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
OA
osteoarthritis
pain
variability
activity
treatment

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

ClinicalTrials.gov processed this record on November 25, 2014