Skip to main content
OpenTrials
Completed

NCT Number: NCT01557231

Epidemiology of Osteoarthritis (OA) Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Use of a walker to ambulate or inability to ambulate (use of cane is allowed)
  • Other forms of arthritis
  • 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
  • Scheduled for and likely to need joint replacement surgery in the next 3 months
  • Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
  • Living in a long-term care facility

Treatment and study plan

Primary outcomes

  1. pain magnitude

    Time frame: 6 months

    magnitude of pain will be evaluated 3x/day

Secondary outcomes

  1. self-reported activity level

    Time frame: 6 months

    data will be collected 3x/day; Likert 1-5 scale

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • ZARS Pharma Inc.

Registry information

Official study title

Epidemiology of OA Pain

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2012
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.