Status:
COMPLETED
Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Conditions:
Chronic Pain
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pain is the principal symptom in knee osteoarthritis (OA) and results in a considerable amount of years lived with disability, emotional distress and has significant socioeconomic consequences. Conser...
Detailed Description
BACKGROUND Pain is the principal symptom in knee osteoarthritis (OA) and results in a considerable amount of years lived with disability, emotional distress and has significant socioeconomic consequen...
Eligibility Criteria
Inclusion
- Referred to GLA:D by a physician.
- Age ≥ 18y
- Chronic knee pain for a minimum duration of 6 months.
- Pain intensity ≥ 40mm on a 100mm visual analogue scale (VAS).
- Radiographic confirmation of osteoarthritis; Grade 2-4 changes according to the Kellgren Lawrence classification system
- A decrease of ≥ 50 % in VAS scores with diagnostic genicular nerve block.
- Written and oral understanding of Danish.
Exclusion
- History of systemic inflammatory conditions such as rheumatoid arthritis.
- Previous recipient of cryoneurolysis for the knee.
- Use of hyaluronic acid within the previous 30 days.
- Injection of corticosteroid within the previous 3 months.
- Clinical significant structural abnormities affecting locomotion and knee function aside from osteoarthritis and which might cause chronic knee pain.
- Body mass index ≥ 18 and ≤ 40 kg/m
- In treatment for other pain conditions.
- Pregnancy
- Coagulopathy
- Uncontrolled serious disease (cancer, diabetes, etc.)
- Disease associated with reactions to cold, such as cryoglobulinemia, cold urticarial and Renaud's syndrome.
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03774121
Start Date
June 26 2019
End Date
March 1 2023
Last Update
October 15 2024
Active Locations (1)
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1
Hospital of Southwest Jutland
Esbjerg, Region Syddanmark, Denmark, 6700