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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