ACTIVE_NOT_RECRUITING

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

Conditions

Osteoarthritis (OA) of the Knee osteoarthritis knee pain osteoarthritis of the knee knee osteoarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-11-19

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06700109

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.

Ages Eligible for Study:22 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Study Locations (Sites)

Marin Health

Larkspur, California, 94939

United States

Centers for Advanced Orthopedics

Washington D.C., District of Columbia, 20036

United States

The Orthopaedic Institute

Gainesville, Florida, 32607

United States

Emory University

Johns Creek, Georgia, 30097

United States

Insight Hospital and Medical Center Chicago

Chicago, Illinois, 60616

United States

NextStage Clinical Research Advanced Orthopaedic Associates

Wichita, Kansas, 67226

United States

Ochsner Health System

New Orleans, Louisiana, 70115

United States

NextStage Clinical Research Regenerative Orthopedics and Sports Medicine

North Bethesda, Maryland, 20852

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Insight Research Institute

Flint, Michigan, 48507

United States

Clinical Investigations, LLC

Edmond, Oklahoma, 73034

United States

NextStage Clinical Research The Orthopedic Center

Tulsa, Oklahoma, 74104

United States

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, 15143

United States

NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute

Houston, Texas, 77058

United States

UT San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2024-11-19

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2024-11-19

Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

osteoarthritis
knee pain
osteoarthritis of the knee
knee osteoarthritis

Additional Relevant MeSH Terms

Osteoarthritis (OA) of the Knee