Data category | Information |
---|---|
Protocol version | Version 1 - 21 January 2021 |
Primary Registry | Clinicaltrial.gov |
Date of Registration | 12-03-2018 |
Sources of Monetary | Danish Health Authority, Danish Rheumatism Association |
Primary Sponsor | Department of Neurology, Hospital South West Jutland, Esbjerg Denmark |
Secondary Sponsor | Research Unit of Health Sciences, Hospital South West Jutland, Esbjerg Denmark |
Contact for Public Queries | Niels-Peter Broechner Nygaard |
Contact for Scientific Queries | Niels-Peter Broechner Nygaard |
Country of Recruitment | Denmark |
Health Condition | Osteoarthritis (DM17) |
Interventions | Cryoneurolysis |
Sham | |
GLA:D | |
Key inclusion and exclusion criteria | Inclusion: Referred to GLA:D, Chronic pain > 6 months, Pain intensity ≥40 mm on the NRS pain scale, OA confirmed by radiography, 50% reduction of pain after diagnostic nerve block |
Exclusion: Systemic inflammatory disease, In treatment for other pain conditions, uncontrolled serious disease (cancer, diabetes, etc.) | |
Study type | Interventional |
Allocation; Randomized controlled; Parallel assignment; Single-blinded (patients and data-manager) | |
Primary purpose; Safety and effectiveness | |
Date if first enrollment | 26-06-20,189 |
Sample size | n = 94 |
Recruitment status | Recruiting |
Primary outcome | Change in Pain intensity score (NRS) after cryoneurolysis, compared between intervention and sham |
Key secondary outcomes | Functional performance |
Quality of Life | |
Adverse effects |