Effect of Knee Pain on Walking Biomechanics

NCT05670236 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 32283
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Gait; Pain; Osteoarthritis; Biomechanics

Outcome Measures

Primary Outcomes (3)

• Change in Medial Knee Contact Forces During Walking

  Contact forces estimated with musculoskeletal modeling

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

• Change in Lateral Knee Contact Forces During Walking

  Contact forces estimated with musculoskeletal modeling

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

• Change in Patellofemoral Knee Contact Forces During Walking

  Contact forces estimated with musculoskeletal modeling

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

Study Arms (2)

Knee Osteoarthritis

EXPERIMENTAL

Individuals with clinically defined unilateral symptomatic knee osteoarthritis.

Drug: Lidocaine Hydrochloride

Healthy

NO INTERVENTION

Individuals who serve as healthy controls.

Interventions

Lidocaine Hydrochloride DRUG

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

Knee Osteoarthritis

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• At least 45 years old

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Patrick Corrigan
• Organization: Cleveland Clinic Foundation

corrigd4@ccf.org

216-618-9932

Study Officials

• Patrick Corrigan, DPT, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Arm 1: Clinically defined unilateral symptomatic knee osteoarthritis; Arm 2: Healthy Controls

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 4, 2023
• Study Start: January 25, 2023
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10

Locations

US (1)