Genicular RFT vs Phenol Management in Patients With Knee Osteoarthritis

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05908942
Collaborator
(none)
64
2
8.9
32
3.6

Study Details

Study Description

Brief Summary

The aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) before, 1 and 3 months after the procedure. The procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.

Condition or Disease Intervention/Treatment Phase
  • Device: Nerve ablation

Detailed Description

Ultrasound-guided genicular nerve ablation is a minimally invasive procedure that reduces or eliminates pain in patients with knee pain by destroying the nerves that transmit pain with heat or chemical drugs such as phenol. Genicular nerve ablation is an effective treatment option for patients with chronic knee pain who cannot undergo prosthesis surgery. In this method, radiofrequency waves or phenol are applied to the nerves going to the knee joint, preventing the transmission of pain signals to the brain.

The procedure is applied as follows:

Haemodynamic monitoring is provided. Superomedial genicular nerve (SMGS), superolateral genicular nerve (SLGS), inferomedial genicular nerve (IMGS) are the nerves to be blocked. The 8-12 Hz linear ultrasound probe is first placed superomedial to the knee and the SMGS and genicular artery are visualised at the junction of the shaft and condyle of the femur. The skin is locally anaesthetised with 2% lidocaine (2 cc) and the needle is inserted in plane with the ultrasound probe. For radiofrequency ablation The cannula placed close to the nerve is connected to the radiofrequency generator with the help of cables. At the tip of the needle, 2% lidocaine (1 cc) is administered and the nerve is heated by applying radiofrequency current. Ablation is performed at 80 °C for 1 minute. This procedure is repeated for other genicular nerves. For phenol ablation, 1 mL of 7% phenol solution is applied to cause neurolysis with the help of a needle placed close to the nerve. Phenol provides ablation by denaturing the proteins in the structure of the nerve.

Patients will be evaluated on NRS and WOMAC scales before, 1 and 3 months after the procedure. The evaluation will be done face to face and by telephone call.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
64 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of the Efficacy of Genicular Nerve Phenol Ablation and Radiofrequency Ablation for Pain Management in Patients With Knee Osteoarthritis
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
RF group

32 patients with knee osteoarthritis to undergo radiofrequency treatment of genicular nerves

Device: Nerve ablation
radiofrequency and phenol ablation of the genicular nerves will be performed

Phenol group

32 patients with knee osteoarthritis to undergo phenol treatment of genicular nerves

Device: Nerve ablation
radiofrequency and phenol ablation of the genicular nerves will be performed

Outcome Measures

Primary Outcome Measures

  1. Numeric rating scale (NRS) [Change from Baseline NRS at 3 months]

    Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.

  2. Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) [Change from Baseline WOMAC at 3 months]

    The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)

  • Permanent pain for more than 6 months

  • Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis

  • Pain with conservative methods such as analgesics and physiotherapy treatment failure

Exclusion Criteria:
  • History of intra-articular knee intervention in the last 6 months

  • Cognitive impairment

  • Hepatic or renal insufficiency

  • Severe psychiatric illness

  • Local or systemic infection

  • Coagulopathy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Etlik City Hospital Ankara Yenimahalle Turkey 06170
2 Diskapi Training and Research Hospital Ankara Turkey

Sponsors and Collaborators

  • Diskapi Teaching and Research Hospital

Investigators

  • Study Chair: Gevher R Genç Perdecioğlu, Diskapi TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Damla Yürük, medical doctor, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT05908942
Other Study ID Numbers:
  • Genicular
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Damla Yürük, medical doctor, Diskapi Teaching and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023