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NCT Number: NCT07308873

Individual Differences in Gait and Osteoarthritis Pain

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 6 minute walk test pain intensity

    Time frame: 6 minutes

    Pain intensity on numeric rating scale (0-10) during and around the time of the 6-minute walk test.

Secondary outcomes

  1. Distance walked in the 6-minute walking test

    Time frame: 6 minutes

    Distance walked during 6 minute walking task

Other outcomes

  1. Quantitative sensory testing

    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.

  2. Physical function performance and pain

    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.

  3. Brain imaging

    Time frame: 2-3 hours

    Brain activity will be measured non-invasively using functional near-infrared spectroscopy

  4. Biomechanics during physical activity

    Time frame: 3-4 hours

    Aspects of body movement will be measured non-invasively during physical performance tests, including the 6-minute walk test

  5. Multidimensional pain assessment

    Time frame: 1 hour

    Multidimensional aspects of chronic pain will be measured through written surveys and a semi-structured clinical evaluation.

  6. Knee MRI

    Time frame: 1 hour

    Structural changes of the knee will be measured, including the use of standard scoring systems.

Study contacts

Contact information is provided by the study sponsor or research team.

Benedict Alter, MD, PhD

CONTACT

[email protected]

412-665-8052

Emma Racunas, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Acronym: INDIGO

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 30, 2025
Registry last updated
Jan 29, 2026

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.

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