Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of the Efficacy of Ultrasound-Guided Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265675
• Other study ID #: E1-4066/2023
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: June 24, 2025

Study information

• Verified date: February 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Rabia Layik
• Phone: +905314087679
• Email: rabialyk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block.

Description:

Knee osteoarthritis is one of most frequent reason of knee pain. There are different treatment methods such as analgesic drug treatment, physical therapy techniques, intraarticular injections and neurolysis techniques. In this study, we will compare neurolysis techniques these are phenol block and corticosteroid local anesthetic block.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 24, 2025
• Est. primary completion date: January 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Phenol
Chemical neurolysis
• Celestone
Chemical neurolysis with corticosteroid
• Lidocain
Chemical neurolysis with local anesthetic

Locations

Country	Name	City	State
Turkey	Gaziler	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS)	Average knee pain is assessed using an 11-point NRS with terminal descriptors of no pain (score 0) and extreme pain (score 10).	Before the intervention, 4 weeks after the intervention and 3 months later
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	We will use the WOMAC in the Likert version where question are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. So the sum of the scores ranges from 0 (the best) to 96 (the worse).	Before the intervention, 4 weeks after the intervention and 3 months later
Secondary	Patient Global Impression of Change (PGIC)	The PGIC in pain and function will be measured with a 5-point Likert scale (1-5) on the applicable follow up visits. The patients will be asked to rate the following statements: Please imagine how you would have described your pain intensity before the procedure. How do you feel today as compared to baseline (Start of the study) as far as your knee pain caused by OA is concerned? Please imagine how you would have described the functionality of your knee before the procedure. How do you feel today as compared to baseline (start of the study) as far as your knee functionality caused by OA is concerned?; The options on the Likert scale are: much better slightly better no change slightly worse much worse	4 weeks after the intervention and 3 months later
Secondary	Sixt Minute Walk Test (6MWT)	A 6 minute walk test is a submaximal exercise test that measures the distance walked over the span of 6 minutes.	Before the intervention, 4 weeks after the intervention and 3 months later
Secondary	The Timed-Up and Go test	This test measures the dynamic balance and functional mobility in older adults.A patient getting up from a chair from the sitting to the bipedal position, walking three meters, turning, returning, and sitting on the chair again.	Before the intervention, 4 weeks after the intervention and 3 months later
Secondary	Frequency of analgesic usage	Assessment of analgesic number that used by patient with knee osteoarthritis	Before the intervention, 4 weeks after the intervention and 3 months later