Your session is about to expire
← Back to Search
Procedure
Injectable Cold Energy Therapy for Knee Arthritis (ICE Trial)
N/A
Recruiting
Research Sponsored by Brixton Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
Age 22 to 80, inclusive of any gender
Must not have
Unwilling to refrain from any scheduled surgeries during the duration of this study
History of Chilblain's (pernio) disease in the lower extremities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if Neural Ice can help treat knee osteoarthritis in adults aged 22-80. Participants will visit the study site, keep diaries, and be monitored for
Who is the study for?
Adults aged 22-80 with chronic pain from knee osteoarthritis can join this trial. Specific details on who can or cannot participate are not provided, so interested individuals should contact the study organizers for full eligibility criteria.
What is being tested?
The trial is testing Neural Ice, a new treatment for managing chronic knee pain due to osteoarthritis, against Triamcinolone acetate, an established therapy. Participants will be monitored over six months and must keep diaries of their condition.
What are the potential side effects?
Potential side effects are not listed in the provided information. However, generally speaking, treatments like these could cause injection site reactions, increased pain or swelling in the knee, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've tried pain relief methods like NSAIDs, physical therapy, or injections for over 3 months without success.
Select...
I am between 22 and 80 years old.
Select...
My pain level is above 5 even with treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not planning any surgeries during this study.
Select...
I have had Chilblain's disease in my legs.
Select...
I have a history of cryoglobulinemia.
Select...
I have a history of Raynaud's disease.
Select...
I have open wounds or active cancer near the area to be treated.
Select...
I've had surgery on the blood vessels in my leg where injections are given.
Select...
I have a history of conditions like rheumatoid arthritis.
Select...
I cannot have certain types of numbing medication due to health reasons.
Select...
I am currently taking more than 60 MME of opioids daily.
Select...
I haven't had certain knee injections in the last 3 to 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Effectiveness
Primary Safety
Secondary study objectives
Secondary Effectiveness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Neural Ice injectionsExperimental Treatment1 Intervention
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Group II: Corticosteroid injectionActive Control1 Intervention
Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.
Find a Location
Who is running the clinical trial?
Brixton Biosciences, Inc.Lead Sponsor