Genicular RFT vs Phenol Management in Patients With Knee Osteoarthritis

NCT ID: NCT05908942

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Pain Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RF group

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

Nerve ablation

Intervention Type DEVICE

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

Nerve ablation

Intervention Type DEVICE

radiofrequency and phenol ablation of the genicular nerves will be performed

Interventions

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Nerve ablation

radiofrequency and phenol ablation of the genicular nerves will be performed

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gevher R Genç Perdecioğlu

Role: STUDY_CHAIR

Diskapi TRH

Locations

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Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Genicular

Identifier Type: -

Identifier Source: org_study_id

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