Clinical trial
Comparison of the Efficacy of Ultrasound-Guided Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve in Patients With Knee Osteoarthritis
Name
E1-4066/2023
Description
There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block.
Trial arms
Trial start
2024-01-24
Estimated PCD
2025-01-24
Trial end
2025-06-24
Status
Recruiting
Treatment
Phenol
Chemical neurolysis
Arms:
Phenol block group
Celestone
Chemical neurolysis with corticosteroid
Arms:
Corticosteroid and local anesthetic
Lidocain
Chemical neurolysis with local anesthetic
Arms:
Corticosteroid and local anesthetic
Size
88
Primary endpoint
Numeric Rating Scale (NRS)
Before the intervention, 4 weeks after the intervention and 3 months later
Eligibility criteria
Inclusion Criteria:
* Patients with knee osteoarthritis must have pain at least 6 months
* NRS score of knee pain equal or more than 5
* At least grade 3 in Kellgren-Lawrence grading scale
* Non responsive to life style change, weight control, exercises program, medical treatment and the other conservative treatments (physical therapy, intraarticular injections)
* Decreasing at NRS score more than %50 after diagnostic block
* Those who accept the consent form
Exclusion Criteria:
* Patients who have acute knee injury
* Surgery history in knee
* Connective tissue disease that affect knee
* Sciatica
* Injection story in last 3 months
* Psychiatric or neurologic diseases that affect study
* Septic arthritis, active local or systemic infection
* Coagulopathy
* Pregnancy
* Allergic reaction
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}
Updated at
2024-02-20
1 organization
3 products
1 indication
Product
PhenolIndication
Osteoarthritis, KneeProduct
CelestoneProduct
Lidocain