Knee ArthritisPhase 2/3NCT05020028

Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis

A Phase 2/3 study testing Cannabidiol (CBD) in people with Knee Arthritis, run by NYU Langone Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Knee Arthritis
What is being tested?: Cannabidiol (CBD)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 22 Jun 2022to Sep 2027
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients presenting with knee osteoarthritis (KL Grade II-III)
Knee pain for at least three months, occurring in at least half of the days in that period
VAS ≥ 4
Patients ages 40-75, inclusive
If female patients are pre-menopausal they must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly
Male patients must be using an effective form of contraception

Who cannot join

Knee Injections within the last 3 months (cortisone, PRP, hyaluronic acid)
Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 40 years of age
Older than 75 years of age
Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners
History of cannabis abuse or dependence

Show all 24Show fewer

History of coagulation abnormalities and thromboembolic disease or current abnormal coagulation test values
History of stroke or acute coronary syndromes within 3 months
Abnormal coagulation profile
Renal failure (serum creatinine > 250 μmol/L [2.83 mg/dL]) or liver cirrhosis
Patients that have been on opioid management for any reason just prior to the study
Patients with known inflammatory arthritis (such as rheumatoid arthritis, gout, pseudogout etc)
Patients with a large effusion
Patients with a BMI > 35
Patients meeting the DSM-V for major psychiatric illness, such as bipolar disorder
Patients diagnosed with major depression, psychosis, or substance abuse disorder
Patients with current or a history of suicidal ideation
Breastfeeding females
Abnormal LFTs
Patients with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain/head injury, or seizures
Patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C).
Patients taking moderate or strong inhibitors of CYP3A4 and CYP2C19 (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians
Patients taking strong CYP3A4 and CYP2C19 inducers (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians
Patients taking substrates of UTG1A9, UTGB17, CYP2A1, CYP2B6, CYP2C8, CYP2C9 and CYP2C19 (listed below) concomitantly will be considered for exclusion if determined to be clinically significant by the treating physicians

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael J Alaia, MD contact

646-501-7223

michael.alaia@nyulangone.org

Layne Estes contact

Layne.estes@nyulangone.org

United States1 site, 1 recruiting

NYU Langone Health
New York, New York, 10016
Michael Alaia, MD
Recruiting

Other trials in United States

About this study

Official title: The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

Read the detailed description

This will be a multi-center, double-blinded, randomized, placebo-controlled study. The study is comparing pain, outcomes, and patient satisfaction in two cohorts: patients with knee OA undergoing physiotherapy/home exercises who receive CBD and a placebo group with PT/home exercise program. Patients will be asked on treatment Day 1, 2, 7, and 14, 28, 42, and 84 to rate their pain according to the VAS scale. Additionally, patient satisfaction and clinical outcomes will be measured.

Conditions: Knee Arthritis
Being tested: Cannabidiol (CBD), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cannabidiol (CBD)Drug
Also called Cannabidiol
Patients will be dispensed enough 25mg cannabidiol (CBD) Orally Disintegrating Tablets (ODT) to take a standard dose of 50mg three times daily for 84 days.
PlaceboDrug
25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.

Study groups in NCT05020028
Study group	Role	What they receive
CBD Group	Experimental	The first cohort will take two 25mg cannabidiol (total dose: 50mg) Orally Disintegrating Tablets (CBD ODT) three times daily for a maximum dose of 150mg per day. Receives: Drug: Cannabidiol (CBD)
Placebo Group	Placebo comparator	Cohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 1
VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 2
VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 7
VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 14
VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 28
VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 42
VAS Pain Severity Score
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
Measured: Day 84

Secondary outcomes (12)

Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items).
Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items).
Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Week 6
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items).
Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Week 12
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The five patient-relevant subscales of KOOS are scored separately: Pain (9 items); Symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items); Quality of Life (4 items).
Patients rank each item using a 5-piont Likert scale ranging from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores are calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Week 60
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 1
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 2
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 7
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 14
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 28
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 42
VAS Satisfaction with Pain Management Score
A Visual Analogue Scale (VAS) will be used to measure patient satisfaction with pain management. Patients rate their satisfaction on a scale ranging from 0 (no satisfaction) to 10 (as satisfied as possible). Total scores range from 0-10; higher scores indicates greater satisfaction with pain management.
Measured: Day 84
Number of Patients Requiring Rescue Corticosteroid Use
Measured: Up to Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 2022Sep 2027

First posted25 Aug 2021
Study start22 Jun 2022
Primary completionSep 2027 (estimated)
Study completionSep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee ArthritisStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05020028
Sponsor's protocol ID: 21-00334
Status last verified: Jun 2026
First submitted: 13 Jul 2021
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The data will only be available to the researchers involved in this study.

Interested in taking part?

Michael J Alaia, MD

646-501-7223

michael.alaia@nyulangone.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Knee Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Cannabidiol (CBD) in Pain Reduction for Knee Osteoarthritis. A Double-Blind, Randomized Control Study
ClinicalTrials.gov ID: NCT05020028
Acronym / sponsor ID: 21-00334
Conditions: Knee Arthritis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: Orcosa Inc.
Study start: 22 Jun 2022 (actual)
Primary completion: Sep 2027 (estimated)
Study completion: Sep 2027 (estimated)
First posted: 25 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
CBD Group	Experimental	Drug: Cannabidiol (CBD)The first cohort will take two 25mg cannabidiol (total dose: 50mg) Orally Disintegrating Tablets (CBD ODT) three times daily for a maximum dose of 150mg per day.
Placebo Group	Placebo comparator	Drug: PlaceboCohort 2 will receive the same instructions, but with the placebo Orally Disintegrating Tablets (ODT) instead.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients presenting with knee osteoarthritis (KL Grade II-III)
Knee pain for at least three months, occurring in at least half of the days in that period
VAS ≥ 4
Patients ages 40-75, inclusive
If female patients are pre-menopausal they must be currently practicing effective forms of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (less than 1% per year) when used consistently and correctly

Key exclusion criteria (24 listed)

Knee Injections within the last 3 months (cortisone, PRP, hyaluronic acid)
Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 40 years of age
Older than 75 years of age
Any patient considered a vulnerable subject: pregnant women or fetuses, children, cognitively impaired adults, prisoners

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
Cannabidiol (CBD)Also: CannabidiolPatients will be dispensed enough 25mg cannabidiol (CBD) Orally Disintegrating Tablets (ODT) to take a standard dose of 50mg three times daily for 84 days.	Drug	CBD Group
Placebo25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.	Drug	Placebo Group

Primary outcome

VAS Pain Severity Score
Time frame: Day 1
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
VAS Pain Severity Score
Time frame: Day 2
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
VAS Pain Severity Score
Time frame: Day 7
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
VAS Pain Severity Score
Time frame: Day 14
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
VAS Pain Severity Score
Time frame: Day 28
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
VAS Pain Severity Score
Time frame: Day 42
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.
VAS Pain Severity Score
Time frame: Day 84
A Visual Analogue Scale (VAS) will be used to measure differences in pain between patients receiving CBD with knee OA undergoing physiotherapy compared to patients who do not receive CBD. Patients rate their pain on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). Total scores range from 0-10; higher scores indicates greater pain intensity.

12 secondary outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 6
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 12
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 60
VAS Satisfaction with Pain Management Score
Time frame: Day 1
VAS Satisfaction with Pain Management Score
Time frame: Day 2
VAS Satisfaction with Pain Management Score
Time frame: Day 7
VAS Satisfaction with Pain Management Score
Time frame: Day 14
VAS Satisfaction with Pain Management Score
Time frame: Day 28
VAS Satisfaction with Pain Management Score
Time frame: Day 42
VAS Satisfaction with Pain Management Score
Time frame: Day 84
Number of Patients Requiring Rescue Corticosteroid Use
Time frame: Up to Week 60

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Individual participant dataSharing planned: No. The data will only be available to the researchers involved in this study.

Related trials for Knee Arthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Michael J Alaia, MD contact

646-501-7223

michael.alaia@nyulangone.org

Layne Estes contact

Layne.estes@nyulangone.org

Michael J Alaia, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cannabidiol (CBD) in people with Knee Arthritis, run by NYU Langone Health 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael J Alaia, MD (646-501-7223, michael.alaia@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Pain Severity Score (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020028.

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 9 Jun 2026.