INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE (ICE)

October 27, 2025 updated by: Brixton Biosciences, Inc.

INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE: A MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY (ICE STUDY)

The goal of this clinical trial is to evaluate the effectiveness of Neural Ice for pain management associated with knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
263

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Larkspur, California, United States, 94939
        • Marin Health
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20036
        • Centers for Advanced Orthopedics
    • Florida
      • Gainesville, Florida, United States, 32607
        • The Orthopaedic Institute
    • Georgia
      • Johns Creek, Georgia, United States, 30097
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Insight Hospital and Medical Center Chicago
    • Kansas
      • Wichita, Kansas, United States, 67226
        • NextStage Clinical Research Advanced Orthopaedic Associates
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Health System
    • Maryland
      • North Bethesda, Maryland, United States, 20852
        • NextStage Clinical Research Regenerative Orthopedics and Sports Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Flint, Michigan, United States, 48507
        • Insight Research Institute
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Clinical Investigations, LLC
      • Tulsa, Oklahoma, United States, 74104
        • NextStage Clinical Research The Orthopedic Center
    • Pennsylvania
      • Sewickley, Pennsylvania, United States, 15143
        • Pain Diagnostics and Interventional Care
    • Texas
      • Houston, Texas, United States, 77058
        • NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute
      • San Antonio, Texas, United States, 78229
        • UT San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 22 to 80, inclusive of any gender
  2. Baseline pain intensity of >/= 5 of the Numeric Rating Scale (NRS) despite current treatment Confidential Brixton Biosciences Inc. Page 12 of 53 Version: 1.1, 30 August 2024
  3. Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, or 4) on plain x-rays obtained within the previous 12 months
  4. At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
  5. Agree to see one doctor (study investigator) for knee pain during the study period
  6. Willing/able to understand the informed consent form and provide written informed consent
  7. Able to complete outcome measures (including electronic patient reported outcome measures)

Exclusion Criteria:

  1. Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
  2. History of cryoglobulinemia
  3. History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
  4. History of cold urticaria
  5. History of Chilblain's (pernio) disease in the lower extremities
  6. History of Raynaud's disease
  7. Open and/or infected wounds or active tumor at or near the treatment site
  8. History of vascular surgery involving femoral vessels on the injection side
  9. History of surgical procedures to affected limb that, in the opinion of the investigator, could have impacted the integrity of the genicular nerves or blood vessels
  10. Active bacterial or fungal infection that at the discretion of the investigator would preclude study participation
  11. Currently taking >60 MME/day, as determined per MDcalc.com (opioid conversion calculator)
  12. History of History of systemic inflammatory conditions such as rheumatoid arthritis
  13. Bleeding disorders anticoagulant therapy, unless appropriately stopped or reversed for the procedure
  14. Any condition or circumstance that would impact or confound assessment of safety and/or pain. For example, comorbid or concomitant pain conditions, pre-existing lower limb neurologic deficits, any psychiatric or neurologic disease
  15. Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
  16. Use of intra-articular injection of corticosteroid within the previous 3 months, or hyaluronic acid, prolotherapy, Confidential Brixton Biosciences Inc. Page 13 of 53 Version: 1.1, 30 August 2024 autologous blood, or platelet rich plasma injections for the index knee within the previous 6 months
  17. Known contraindication to use of a regional anesthetic block
  18. Pregnant, nursing or intent of becoming pregnant during the study period
  19. Any condition (such as history of significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
  20. Body habitus/knee anatomy that would preclude the use of the product injection needle size
  21. Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
  22. Unwilling to refrain from participation in any other clinical study through the duration of this study
  23. Unwilling to refrain from any scheduled surgeries during the duration of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neural Ice injections
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Device: Neural Ice
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Active Comparator: Corticosteroid injection
Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.
Drug: Triamcinolone acetate
A single dose of Triamcinolone 40mg injected directly into the joint space.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness
Time Frame: 3 months
The proportion of subjects whose knee pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment.
3 months
Primary Safety
Time Frame: 6 months
Aggregate serious device-related adverse events through final follow up visit.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Effectiveness
Time Frame: 6 months
The proportion of subjects whose knee pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 6 months post treatment.
6 months
NRS Scores
Time Frame: 6 months
6 months
Pain medication usage
Time Frame: 6 months
6 months
PGIC scores
Time Frame: 6 months
6 months
KOOS, JR scores
Time Frame: 6 months
6 months
Onset of pain relief defined as pain reduced by 30% based on NRS score from baseline
Time Frame: 6 months
6 months
Change in Timed-Up and Go (TUG) test scores from baseline
Time Frame: 6 months
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Patient-Specific Functional Scale (PSFS)
Time Frame: 6 months
6 months
Knee procedures specific Healthcare Utilization Data
Time Frame: 6 months
6 months
EQ-5D-5L Global Quality of Life measure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brixton Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BXT-786-KPM-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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