Osteoarthritis (OA) of the KneeICENCT06700109
INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE
A study testing Neural Ice and Triamcinolone acetate in people with Osteoarthritis (OA) of the Knee, run by Brixton Biosciences, Inc. at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Neural Ice and Triamcinolone acetate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 15 sitesUnited States
- Study dates
- 19 Nov 2024to 1 Feb 2027
- Phase
- Interventional
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 to 80, inclusive of any gender
- 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
- Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, or 4) on plain x-rays obtained within the previous 12 months
- At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
- Agree to see one doctor (study investigator) for knee pain during the study period
- Willing/able to understand the informed consent form and provide written informed consent
- Able to complete outcome measures (including electronic patient reported outcome measures)
Who cannot join
- Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
- History of cryoglobulinemia
- History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
- History of cold urticaria
- History of Chilblain's (pernio) disease in the lower extremities
- History of Raynaud's disease
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- Open and/or infected wounds or active tumor at or near the treatment site
- History of vascular surgery involving femoral vessels on the injection side
- 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
- Active bacterial or fungal infection that at the discretion of the investigator would preclude study participation
- Currently taking >60 MME/day, as determined per MDcalc.com (opioid conversion calculator)
- History of History of systemic inflammatory conditions such as rheumatoid arthritis
- Bleeding disorders anticoagulant therapy, unless appropriately stopped or reversed for the procedure
- 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
- Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
- 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
- Known contraindication to use of a regional anesthetic block
- Pregnant, nursing or intent of becoming pregnant during the study period
- 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
- Body habitus/knee anatomy that would preclude the use of the product injection needle size
- Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
- Unwilling to refrain from participation in any other clinical study through the duration of this study
- Unwilling to refrain from any scheduled surgeries during the duration of this study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Insight Hospital and Medical Center Chicago
Chicago, Illinois, 60616
Clinical Investigations, LLC
Edmond, Oklahoma, 73034
Insight Research Institute
Flint, Michigan, 48507
The Orthopaedic Institute
Gainesville, Florida, 32607
NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute
Houston, Texas, 77058
Emory University
Johns Creek, Georgia, 30097
Marin Health
Larkspur, California, 94939
Ochsner Health System
New Orleans, Louisiana, 70115
NextStage Clinical Research Regenerative Orthopedics and Sports Medicine
North Bethesda, Maryland, 20852
UT San Antonio
San Antonio, Texas, 78229
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143
NextStage Clinical Research The Orthopedic Center
Tulsa, Oklahoma, 74104
Centers for Advanced Orthopedics
Washington D.C., District of Columbia, 20036
NextStage Clinical Research Advanced Orthopaedic Associates
Wichita, Kansas, 67226
About this study
Official title: 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.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Neural Ice, Triamcinolone acetate
- Keywords
- osteoarthritis, knee pain, osteoarthritis of the knee, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural IceDevice
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Triamcinolone acetateDrug
A single dose of Triamcinolone 40mg injected directly into the joint space.
| Study group | Role | What they receive |
|---|---|---|
| Neural Ice injections | Experimental | This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves. Receives: Device: Neural Ice |
| Corticosteroid injection | Active comparator | Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space. Receives: Drug: Triamcinolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness
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.
Measured: 3 months
Primary Safety
Aggregate serious device-related adverse events through final follow up visit.
Measured: 6 months
Secondary outcomes (7)
Secondary Effectiveness
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.
Measured: 6 months
NRS Scores
Measured: 6 months
Pain medication usage
Measured: 6 months
PGIC scores
Measured: 6 months
KOOS, JR scores
Measured: 6 months
Onset of pain relief defined as pain reduced by 30% based on NRS score from baseline
Measured: 6 months
Change in Timed-Up and Go (TUG) test scores from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start19 Nov 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brixton Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700109
- Sponsor's protocol ID
- BXT-786-KPM-03
- Acronym
- ICE
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2024
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE: A MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY (ICE STUDY)
- ClinicalTrials.gov ID
- NCT06700109
- Acronym / sponsor ID
- ICE / BXT-786-KPM-03
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- osteoarthritis, knee pain, osteoarthritis of the knee, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Brixton Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Nov 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY
| Arm | Type | Receives |
|---|---|---|
| Neural Ice injections | Experimental | Device: Neural IceThis therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves. |
| Corticosteroid injection | Active comparator | Drug: Triamcinolone acetateIntraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 22 to 80, inclusive of any gender
- 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
- Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, or 4) on plain x-rays obtained within the previous 12 months
- At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
- Agree to see one doctor (study investigator) for knee pain during the study period
Key exclusion criteria (23 listed)
- Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
- History of cryoglobulinemia
- History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
- History of cold urticaria
- History of Chilblain's (pernio) disease in the lower extremities
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 |
|---|---|---|
| Neural IceThis therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves. | Device | Neural Ice injections |
| Triamcinolone acetateA single dose of Triamcinolone 40mg injected directly into the joint space. | Drug | Corticosteroid injection |
Primary outcome
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.
Primary Safety
Time frame: 6 months
Aggregate serious device-related adverse events through final follow up visit.
7 secondary outcomes
Secondary Effectiveness
Time frame: 6 months
NRS Scores
Time frame: 6 months
Pain medication usage
Time frame: 6 months
PGIC scores
Time frame: 6 months
KOOS, JR scores
Time frame: 6 months
Onset of pain relief defined as pain reduced by 30% based on NRS score from baseline
Time frame: 6 months
Change in Timed-Up and Go (TUG) test scores from baseline
Time frame: 6 months
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 28 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Ice and Triamcinolone acetate in people with Osteoarthritis (OA) of the Knee, run by Brixton Biosciences, Inc. at 15 sites 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 7 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 28 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 15 sites 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.
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?
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?
Primary Effectiveness (time frame: 3 months). The study lists 2 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 28 Oct 2025.