NCT07308873 · University of Pittsburgh
Individual Differences in Gait and Osteoarthritis Pain
(INDIGO)
What this study is about
The goal of this observational study is to look at inter-individual differences in knee osteoarthritis (OA) walking pain and performance.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Breastfeeding
- Inability to under knee MRI scan due to incompatible devices or foreign bodies.
Where
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations