Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-12-31
2030-08-01
Brief Summary
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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
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Chronic knee pain with knee osteoarthritis
Adults 45-80 years old who have moderately severe knee osteoarthritis. They must have experienced knee pain for greater than 6 months and rate their daily knee pain at \>3 on a 0-10 numeric rating scale.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
80 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Benedict Alter
Assistant Professor
Principal Investigators
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Benedict Alter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Pain Medicine at Centre Commons
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY25080027
Identifier Type: -
Identifier Source: org_study_id