Effect of Knee Pain on Walking Biomechanics

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Lidocaine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patrick Corrigan, DPT, PhD; Phone Number: 314-977-8541; Email: patrick.corrigan@health.slu.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Recruiting
      • Saint Louis University
      • Contact: Patrick Corrigan, DPT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Knee Osteoarthritis; Individuals with clinically defined unilateral symptomatic knee osteoarthritis.	Drug: Lidocaine Hydrochloride; 10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
No Intervention: Healthy; Individuals who serve as healthy controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medial knee contact forces during walking	Contact forces estimated with musculoskeletal modeling	Change from baseline to immediately after treatment
Change in lateral knee contact forces during walking	Contact forces estimated with musculoskeletal modeling	Change from baseline to immediately after treatment
Change in patellofemoral knee contact forces during walking	Contact forces estimated with musculoskeletal modeling	Change from baseline to immediately after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee joint angles during walking	Angles derived from kinematic analyses	Change from baseline to immediately after treatment
Change in knee joint moments during walking	Moments derived from kinetic analyses	Change from baseline to immediately after treatment
Change in knee joint work during walking	Work derived from energetic analyses	Change from baseline to immediately after treatment

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Patrick Corrigan, DPT, PhD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Gait; Biomechanics
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 32283

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes