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Table 2 WHO data registration items

From: Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial

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