UPMC Pain Medicine at Centre Commons
Pittsburgh, Pennsylvania, 15206, United States
Location status: Recruiting
NCT Number: NCT07308873
The goal of this observational study is to look at inter-individual differences in knee osteoarthritis (OA) walking pain and performance. The main questions this study aims to answer are:
Why do some people with knee osteoarthritis have more severe disabling pain than others, even though the degenerative changes in their knees are similar?
What are the factors that contribute to walking pain in people with knee osteoarthritis?
Participants will complete surveys, perform physical function tasks, get a knee X-ray and MRI, undergo non-invasive brain imaging, and undergo sensory testing.
Interested in participating?
Request Info45 year–80 year
All sexes
Observational
Pittsburgh, Pennsylvania, 15206, United States
Location status: Recruiting
This observational study will identify biopsychosocial factors that contribute to inter-individual differences in walking pain and pain limiting walking with the hypothesis that neural processes play a key role. This study's objective is to elucidate "whole person" biopsychosocial mechanisms of movement-evoked pain and pain limitations on function in knee OA, helping to determine why some patients have severe disabling pain while others do not despite similar degenerative changes of the knee joint. Three hundred participants with knee OA will undergo a comprehensive data collection over two study visits, including surveys, exercise tasks, non-invasive brain and joint imaging, and biomechanics assessments during mobility. Using advanced analysis, this dataset will be used to identify factors contributing to walking-evoked pain and functional limitations in knee osteoarthritis.These results will identify new therapeutic targets to maintain or improve physical activity in patients with knee osteoarthritis, leading to better outcomes of physical therapy and improved overall health and well-being.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 minutes
Pain intensity on numeric rating scale (0-10) during and around the time of the 6-minute walk test.
Time frame: 6 minutes
Distance walked during 6 minute walking task
Time frame: 2-3 hours
Responses to quantitative sensory tests that assess sensation of painful and non-painful stimuli. The stimuli are calibrated and carefully controlled with safety measures to prevent tissue damage.
Time frame: 2-3 hours
A battery of standardized physical function tests including a stair climb test, fast-paced walk test, balance test, and sit-to-stand test, will be done to measure physical performance. Outcome measurements include the time to complete the test, distance walked, and number of repetitions. Pain intensity is reported on the numeric rating scale (0-10) during this battery of tests.
Time frame: 2-3 hours
Brain activity will be measured non-invasively using functional near-infrared spectroscopy
Time frame: 3-4 hours
Aspects of body movement will be measured non-invasively during physical performance tests, including the 6-minute walk test
Time frame: 1 hour
Multidimensional aspects of chronic pain will be measured through written surveys and a semi-structured clinical evaluation.
Time frame: 1 hour
Structural changes of the knee will be measured, including the use of standard scoring systems.
Contact information is provided by the study sponsor or research team.
Benedict Alter, MD, PhD
CONTACT
Emma Racunas, BS
CONTACT
University of Pittsburgh
Other
Acronym: INDIGO
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.
Published trials that share one or more normalized conditions with this study.
NCT07481461
Arthritis, Joint Diseases
Leuven, Vlaams-Brabant, Belgium
View Trial DetailsNCT06781463
Arthritis, Joint Diseases
Chicago, Illinois, United States
View Trial DetailsNCT07036003
Arthritis, Joint Diseases
Toronto, Ontario, Canada
View Trial DetailsNCT06911359
Arthritis, Joint Diseases
Travis AFB, California, United States
View Trial Details