Back to resultsEffect of Knee Pain on Walking Biomechanics
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine Hydrochloride
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis, Knee focused on measuring Gait, Pain, Osteoarthritis, Biomechanics
Eligibility 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 lower body surgery History of lower body trauma 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 lower body surgery History of lower body trauma 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
Sites / Locations
- Saint Louis UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Knee Osteoarthritis
Healthy
Arm Description
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Individuals who serve as healthy controls.
Outcomes
Primary Outcome Measures
Change in medial knee contact forces during walking
Contact forces estimated with musculoskeletal modeling
Change in lateral knee contact forces during walking
Contact forces estimated with musculoskeletal modeling
Change in patellofemoral knee contact forces during walking
Contact forces estimated with musculoskeletal modeling
Secondary Outcome Measures
Change in knee joint angles during walking
Angles derived from kinematic analyses
Change in knee joint moments during walking
Moments derived from kinetic analyses
Change in knee joint work during walking
Work derived from energetic analyses
Full Information
NCT ID
NCT05670236
First Posted
November 29, 2022
Last Updated
January 30, 2023
Sponsor
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT05670236
Brief Title
Effect of Knee Pain on Walking Biomechanics
Official Title
Effect of Knee Pain on Walking Biomechanics
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Gait, Pain, Osteoarthritis, Biomechanics
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Clinically defined unilateral symptomatic knee osteoarthritis;
Arm 2: Healthy Controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Knee Osteoarthritis
Arm Type
Experimental
Arm Description
Individuals with clinically defined unilateral symptomatic knee osteoarthritis.
Arm Title
Healthy
Arm Type
No Intervention
Arm Description
Individuals who serve as healthy controls.
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Intervention Description
10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
Primary Outcome Measure Information:
Title
Change in medial knee contact forces during walking
Description
Contact forces estimated with musculoskeletal modeling
Time Frame
Change from baseline to immediately after treatment
Title
Change in lateral knee contact forces during walking
Description
Contact forces estimated with musculoskeletal modeling
Time Frame
Change from baseline to immediately after treatment
Title
Change in patellofemoral knee contact forces during walking
Description
Contact forces estimated with musculoskeletal modeling
Time Frame
Change from baseline to immediately after treatment
Secondary Outcome Measure Information:
Title
Change in knee joint angles during walking
Description
Angles derived from kinematic analyses
Time Frame
Change from baseline to immediately after treatment
Title
Change in knee joint moments during walking
Description
Moments derived from kinetic analyses
Time Frame
Change from baseline to immediately after treatment
Title
Change in knee joint work during walking
Description
Work derived from energetic analyses
Time Frame
Change from baseline to immediately after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 lower body surgery
History of lower body trauma
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 lower body surgery
History of lower body trauma
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Corrigan, DPT, PhD
Phone
314-977-8541
Email
patrick.corrigan@health.slu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Corrigan, DPT, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Corrigan, DPT, PhD
12. IPD Sharing Statement
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Effect of Knee Pain on Walking Biomechanics
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