INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE
NCT06700109 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263
Last updated 2025-10-28
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.
Conditions
- Osteoarthritis (OA) of the Knee
Interventions
- DEVICE
-
Neural Ice
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
- DRUG
-
Triamcinolone acetate
A single dose of Triamcinolone 40mg injected directly into the joint space.
Sponsors & Collaborators
-
Brixton Biosciences, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-19
- Primary Completion
- 2027-02-01
- Completion
- 2027-02-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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