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

NCT06265675 | Recruiting

• 1 other identifier: E1-4066/2023
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Genicular nerve; Phenol; Knee Osteoarthritis; Neurolysis; Nerve Blockage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Before the intervention, 4 weeks after the intervention and 3 months later

• Patient Global Impression of Change (PGIC)

  4 weeks after the intervention and 3 months later

• Sixt Minute Walk Test (6MWT)

  Before the intervention, 4 weeks after the intervention and 3 months later

• The Timed-Up and Go test

  Before the intervention, 4 weeks after the intervention and 3 months later

• Frequency of analgesic usage

  Before the intervention, 4 weeks after the intervention and 3 months later

Study Arms (2)

Phenol block group

EXPERIMENTAL

Drug: Phenol

Corticosteroid and local anesthetic

ACTIVE COMPARATOR

Drug: Celestone; Drug: Lidocain

Interventions

Phenol DRUG

Chemical neurolysis

Phenol block group

Celestone DRUG

Chemical neurolysis with corticosteroid

Corticosteroid and local anesthetic

Lidocain DRUG

Chemical neurolysis with local anesthetic

Corticosteroid and local anesthetic

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Phenol; Betamethasone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Rabia Layık

CONTACT

+905314087679; rabialyk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. dr.

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: February 20, 2024
• Study Start: January 24, 2024
• Primary Completion: January 24, 2025
• Study Completion: June 24, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)