INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE
NCT ID: NCT06700109
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
263 participants
INTERVENTIONAL
2024-11-19
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Neural Ice injections
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Neural Ice
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Corticosteroid injection
Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.
Triamcinolone acetate
A single dose of Triamcinolone 40mg injected directly into the joint space.
Interventions
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Neural Ice
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Triamcinolone acetate
A single dose of Triamcinolone 40mg injected directly into the joint space.
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
80 Years
ALL
No
Sponsors
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Brixton Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Marin Health
Larkspur, California, United States
Centers for Advanced Orthopedics
Washington D.C., District of Columbia, United States
The Orthopaedic Institute
Gainesville, Florida, United States
Emory University
Johns Creek, Georgia, United States
Insight Hospital and Medical Center Chicago
Chicago, Illinois, United States
NextStage Clinical Research Advanced Orthopaedic Associates
Wichita, Kansas, United States
Ochsner Health System
New Orleans, Louisiana, United States
NextStage Clinical Research Regenerative Orthopedics and Sports Medicine
North Bethesda, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Insight Research Institute
Flint, Michigan, United States
Clinical Investigations, LLC
Edmond, Oklahoma, United States
NextStage Clinical Research The Orthopedic Center
Tulsa, Oklahoma, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States
NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute
Houston, Texas, United States
UT San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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BXT-786-KPM-03
Identifier Type: -
Identifier Source: org_study_id
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