Individual Differences in Gait and Osteoarthritis Pain

ConditionsKnee Osteoarthritis (OA)Chronic Pain Chronic Knee Pain

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age45-80

SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The sample includes participants with knee osteoarthritis of at least moderate pain severity and radiographic evidence of significant knee joint degeneration. Participants will be recruited from research registries (Pitt CTSI Pitt+Me) and clinics with a high volume of knee osteoarthritis patients, including orthopedic and pain management clinics. Eligibility criteria are designed to study knee osteoarthritis pain around the time of walking. Therefore, some comorbidities and pain conditions are allowed if knee osteoarthritis is the primary pain condition, but other painful conditions are not allowed due to a significant confounding effect on the study. Concurrent knee interventions, such as injections, have different expected time courses of treatment effects. The exclusion criteria timepoints for each intervention are meant to enroll participants at a relatively stable periods of time after the interventions, so that pain and function do not change dramatically across Study Visits.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

300 Participants

are grouped into 1 trial group

Group A: Chronic knee pain with knee osteoarthritis

Trial outcomes

Primary outcomes

6 minute walk test pain intensity

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

Time frame

6 minutes

Secondary outcomes

Distance walked in the 6-minute walking test

Distance walked during 6 minute walking task

Time frame

6 minutes

Other outcomes

Quantitative sensory testing

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

Physical function performance and pain

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 imaging

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

Time frame

2-3 hours

Biomechanics during physical activity

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

Time frame

3-4 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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