INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE: A MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY (ICE STUDY)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:
• 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)
Locations
United States
California
Marin Health
NOT_YET_RECRUITING
Larkspur
Washington, D.c.
Centers for Advanced Orthopedics
NOT_YET_RECRUITING
Washington D.c.
Florida
The Orthopaedic Institute
RECRUITING
Gainesville
Georgia
Emory University
RECRUITING
Johns Creek
Illinois
Insight Hospital and Medical Center Chicago
NOT_YET_RECRUITING
Chicago
Kansas
NextStage Clinical Research Advanced Orthopaedic Associates
RECRUITING
Wichita
Louisiana
Ochsner Health System
NOT_YET_RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
NextStage Clinical Research Regenerative Orthopedics and Sports Medicine
SUSPENDED
North Bethesda
Michigan
Insight Research Institute
RECRUITING
Flint
Oklahoma
Clinical Investigations, LLC
RECRUITING
Edmond
NextStage Clinical Research The Orthopedic Center
RECRUITING
Tulsa
Pennsylvania
Pain Diagnostics and Interventional Care
RECRUITING
Sewickley
Texas
NextStage Clinical Research All-American Orthopedic & Sports Medicine Institute
RECRUITING
Houston
UT San Antonio
NOT_YET_RECRUITING
San Antonio
Contact Information
Primary
David Curd
david.curd@brixtonbio.com
314-480-2244
Time Frame
Start Date:2024-11-19
Estimated Completion Date:2027-02-01
Participants
Target number of participants:263
Treatments
Experimental: Neural Ice injections
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.