Clinical Trial Finder

Effect of Knee Pain on Walking Biomechanics

Study Purpose

The goal of this study is to determine if pain in one knee influences loading of the other knee during different types of walking. The main questions it aims to answer are:

  • - How does unilateral knee pain affect contralateral knee joint loading during different types of walking? - Does movement and loading change at the hips, knees, and ankles during prolonged walking in persons with painful knee osteoarthritis? Participants will: - Fill out questionnaires/surveys.
  • - Complete clinical examinations.
  • - Walking on a treadmill under different types of walking conditions.
  • - Receive two knee injections For comparison purposes, researchers will also enroll healthy participants.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 45 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for Knee Osteoarthritis Arm:

  • - At least 45 years old.
  • - Unilateral knee pain with walking that averages at least 3 out of 10 on a numeric pain rating scale.
  • - Unilateral knee stiffness that lasts less than 30 minutes after periods of inactivity.
  • - Unilateral symptoms on most days for at least the past 3 months.
Exclusion Criteria for Knee Osteoarthritis Arm:
  • - History of knee replacement surgery.
  • - Opiate use within the past 3 months.
  • - Narcotic use within the past 3 months.
  • - Known medical condition that affects walking mechanics, besides knee osteoarthritis.
  • - Known medical condition that affects pain perception.
  • - Inability to walk for 30 minutes without using an assistive device.
  • - Body weight greater than 300 pounds.
  • - Known allergy to adhesives.
  • - High risk for a cardiovascular event.
  • - Currently pregnant.
  • - Anticoagulant use within the past 3 months.
  • - Intraarticular knee injection within the past 3 months.
  • - Known history of hypersensitivity to local anesthetics of the amide type.
  • - History of lower body pain or injury, besides knee osteoarthritis, within the past 6 months.
Inclusion Criteria for Healthy Arm:
  • - At least 45 years old.
  • - No lower body pain or injury within the past 6 months.
Exclusion Criteria for Healthy Arm:
  • - History of knee replacement surgery.
  • - Opiate use within the past 3 months.
  • - Narcotic use within the past 3 months.
  • - Known medical condition that affects walking mechanics.
  • - Known medical condition that affects pain perception.
  • - Inability to walk for 30 minutes without using an assistive device.
  • - Body weight greater than 300 pounds.
  • - Known allergy to adhesives.
  • - High risk for a cardiovascular event.
- Currently pregnant

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05670236
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 St. Louis University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Patrick Corrigan, DPT, PhD
Principal Investigator Affiliation St. Louis University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Additional Details

This study will evaluate the effects of unilateral knee pain on contralateral knee joint loading during different types of walking. Thirty adults with unilateral symptomatic knee osteoarthritis will complete four, 1.5-hour study visits. The first and third visits will include level, inclined, and declined walking at comfortable, fast, and slow speeds. The second and fourth visits will include a 30-minute walk. There will be at least two days between visits. The only difference between each pair of visits is that one visit will involve walking with unilateral knee pain (painful walking) and the other visit will involve walking without unilateral knee pain (nonpainful walking). Individuals will be recruited based on the presence of unilateral knee pain so the painful walking will be representative of their typical walking. For the visits with nonpainful walking, the third and fourth visits, pain will be alleviated by performing an intraarticular injection with a local anesthetic (lidocaine hydrochloride). All walking will be performed in a three-dimensional motion capture environment on a split-belt treadmill that is instrumented with force plates. A cohort of 30 healthy individuals will complete the same walking conditions at two, 1.5-hour study visits. The healthy control group will not receive intraarticular knee injections. The purpose of this cohort is to better understand how walking mechanics in individuals with unilateral knee osteoarthritis compare to similar individuals without knee osteoarthritis.

Arms & Interventions

Arms

Experimental: Knee Osteoarthritis

Individuals with clinically defined unilateral symptomatic knee osteoarthritis.

No Intervention: Healthy

Individuals who serve as healthy controls.

Interventions

Drug: - Lidocaine Hydrochloride

10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Saint Louis University, Saint Louis, Missouri

Status

Recruiting

Address

Saint Louis University

Saint Louis, Missouri, 63104

Site Contact

Patrick Corrigan, DPT, PhD

[email protected]

314-977-8541

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