Individual Differences in Gait and Osteoarthritis Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis (OA), Chronic Pain, Chronic Knee Pain. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- 6 minute walk test pain intensity [Time frame: 6 minutes]
Secondary outcome measures (1)
- Distance walked in the 6-minute walking test [Time frame: 6 minutes]
Eligibility criteria
Inclusion criteria
- Knee pain for greater than 6 months.
- Moderate-to-severe knee pain (>3/10) due to osteoarthritis, as defined by American College of Rheumatology and EULAR diagnostic criteria, on >50% of days in the past month.
- KL grade 2-4 indicating significant degenerative changes on knee X-ray.
- 45-80 years old
Exclusion criteria
- Inflammatory arthritis (e.g. rheumatoid arthritis).
- More intense pain due to another chronic pain syndrome (e.g. fibromyalgia, hip osteoarthritis)
- Significant pain or weakness in the lower extremities due to a neurological condition (e.g. lumbar radiculopathy, paresis due to stroke)
- Acute pain that is more intense than knee osteoarthritis pain
- Current routine use of more than 15 mg oral morphine equivalents per day (use of <15 mg OME does not exclude the participant).
- Recent new medication, exercise, behavioral, or complementary and integrative treatment started in the last month. Stable use of these treatments for greater than 1 month does not exclude the participant.
- Recent intra-articular injection of steroid or other agent (greater than 1 month does not exclude the participant)
- Recent knee radiofrequency ablation (greater than 3 months does not exclude the participant)
- Recent knee arthroscopic surgery (greater than 3 months does not exclude the participant)
- History of knee replacement or open knee surgery on the index knee, defined as the more painful knee on average over the last month.
- Inability to walk or climb stairs without significant assistance (e.g. a one-person assist, use a wheel chair; however, the use of a cane does not exclude the participant).
- Inability to participate in study procedures (e.g. cognitive impairment limiting ability to understand directions, inability to understand and read English)
- Uncontrolled or unstable medical disorder preventing participation in study procedures
- History of brain surgery
- Tattoos on sensory testing sites
- Pregnancy
- Breastfeeding
- Inability to under knee MRI scan due to incompatible devices or foreign bodies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UPMC Pain Medicine at Centre Commons — Pittsburgh
Identifiers
NCT: NCT07308873 · STUDY25080027 · 1R01AR086796-01