Osteoarthritis, KneePhase 4NCT05670236
Effect of Knee Pain on Walking Biomechanics
A Phase 4 study testing Lidocaine Hydrochloride in people with Osteoarthritis, Knee, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 19 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- At least 45 years old
- No lower body pain or injury within the past 6 months
Who cannot join
- 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
Show all 24Show fewer
- 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
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Lidocaine Hydrochloride
- Keywords
- Gait, Pain, Osteoarthritis, Biomechanics
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Experimental | Individuals with clinically defined unilateral symptomatic knee osteoarthritis. Receives: Drug: Lidocaine Hydrochloride |
| Healthy | No intervention | Individuals who serve as healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medial Knee Contact Forces During Walking
Contact forces estimated with musculoskeletal modeling
Measured: 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
Measured: 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
Measured: Change from before treatment (approximately 1 week prior to the injection visit) to 30 minutes after treatment (the injection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start25 Jan 2023
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: Clinically defined unilateral symptomatic knee osteoarthritis; Arm 2: Healthy Controls
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Corrigan, The Cleveland Clinic
- Investigators
- Patrick Corrigan, DPT, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670236
- Sponsor's protocol ID
- 32283
- Status last verified
- Oct 2025
- First submitted
- 29 Nov 2022
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Knee Pain on Walking Biomechanics
- ClinicalTrials.gov ID
- NCT05670236
- Acronym / sponsor ID
- 32283
- Conditions
- Osteoarthritis, Knee
- Keywords
- Gait, Pain, Osteoarthritis, Biomechanics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Clinically defined unilateral symptomatic knee osteoarthritis; Arm 2: Healthy Controls
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | Experimental | Drug: Lidocaine HydrochlorideIndividuals with clinically defined unilateral symptomatic knee osteoarthritis. |
| Healthy | No intervention | –Individuals who serve as healthy controls. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- At least 45 years old
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine Hydrochloride10 mL of 1% lidocaine hydrochloride for each intraarticular knee injection | Drug | Knee Osteoarthritis |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Corrigan, DPT, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Hydrochloride in people with Osteoarthritis, Knee, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.