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Clinical Trials/NCT05670236
NCT05670236
Completed
Phase 4

Effect of Knee Pain on Walking Biomechanics

The Cleveland Clinic1 site in 1 country55 target enrollmentJanuary 25, 2023

Overview

Phase
Phase 4
Intervention
Lidocaine Hydrochloride
Conditions
Osteoarthritis, Knee
Sponsor
The Cleveland Clinic
Enrollment
55
Locations
1
Primary Endpoint
Change in Medial Knee Contact Forces During Walking
Status
Completed
Last Updated
6 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2023
End Date
July 19, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Corrigan

Assistant Professor

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Knee Osteoarthritis

Individuals with clinically defined unilateral symptomatic knee osteoarthritis.

Intervention: Lidocaine Hydrochloride

Outcomes

Primary Outcomes

Change in Medial Knee Contact Forces During Walking

Time Frame: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).

Contact forces estimated with musculoskeletal modeling

Change in Lateral Knee Contact Forces During Walking

Time Frame: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).

Contact forces estimated with musculoskeletal modeling

Change in Patellofemoral Knee Contact Forces During Walking

Time Frame: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).

Contact forces estimated with musculoskeletal modeling

Study Sites (1)

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