A Study Investigating the Coolio System for Pain Management in Patients with Osteoarthritis of the Knee

Not Applicable

• Conditions: Osteoarthritis of the knee; Pain management; Musculoskeletal - Osteoarthritis; Anaesthesiology - Pain management

• Registration Number: ACTRN12624000250538
• Lead Sponsor: Brixton Biosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-14
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Baseline pain intensity of at least 5 on the Numeric Rating Scale (NRS), despite current treatment
- A decrease of at least 50% from baseline Numeric Rating Scale (NRS) with diagnostic genicular nerve block
- Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, 4) on plain x-rays
- Failed conservative treatments (NSAIDs, acetaminophen, physical therapy, and cortisone injections).

Exclusion Criteria

- History of cryoglobulinemia
- History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
- History of cold urticaria
- History of Chilblain’s (pernio) disease in the lower extremities
- History of Raynaud’s disease
- Currently taking >60 MME/day, as determined per opioid conversion calculator
- Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
- Use of intra-articular injection of corticosteroid, hyaluronic acid, prolotherapy, autologous blood, or platelet rich plasma injections for the index knee within the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate any adverse events that may occur from the point of administration of Coolio Neural Ice through the subject's final study assessment.[Examples of adverse events to be evaluated include the incidence of progressive pain at the injection site; incidence of severe or progressive inflammation, redness, bruising, swelling, altered sensation, hypersensitivity, or tender nodule at or distal to the injection site; incidence of infection.<br>Adverse events will be evaluated through quantitative testing by the investigator, such as sensory and vascular assessments of the lower limb. Investigators will also perform range of motion testing and review the KOOS questionnaire for subject feedback. Adverse events will be evaluated weekly throughout the 6-month follow-up period. ]