Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis

NCT ID: NCT07125768

Last Updated: 2025-08-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-01

Brief Summary

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This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain.

Detailed Description

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Knee osteoarthritis is a degenerative joint disease characterized by the degradation of the articular cartilage, with many factors implicated in the disease pathogenesis.

Chronic pain of knee osteoarthritis is a common clinical symptom leading to restricted movement, disability, psychological distress, and impaired quality of life.

The targeted genicular nerves are those that had a close topographic relationship with the bone cortical surfaces, such as the femoral epicondyles (Superior medial \[SM\] and Superior lateral \[SL\] genicular nerves) and the medial tibial epicondyle (Inferior medial \[IM\] genicular nerve).

Nerve ablation causes iatrogenic neural degeneration, aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using radiofrequency or chemical ablation using alcohol or phenol.

Chemical neurolysis techniques can be an effective method to accomplish a larger, more thorough lesioning than radiofrequency ablation and are capable of covering the anatomical variability of genicular nerves, so ensuring a better success rate and outcome with less cost and less logistic support.

Conditions

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Thermal Radiofrequency Neurolysis Alcoholic Neurolysis Genicular Nerves Treatment Chronic Knee Pain Advanced Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I

Patients received C-arm guided neurolysis of superior medial \[SM\], superior lateral \[SL\], and inferior medial \[IM\] genicular nerves by thermal radiofrequency.

Group Type EXPERIMENTAL

Thermal Radiofrequency Neurolysis

Intervention Type OTHER

Patients received C-arm guided neurolysis of superior medial \[SM\], superior lateral \[SL\], and inferior medial \[IM\] genicular nerves by thermal radiofrequency.

Group II

Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.

Group Type ACTIVE_COMPARATOR

Alcoholic Neurolysis

Intervention Type OTHER

Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.

Interventions

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Thermal Radiofrequency Neurolysis

Patients received C-arm guided neurolysis of superior medial \[SM\], superior lateral \[SL\], and inferior medial \[IM\] genicular nerves by thermal radiofrequency.

Intervention Type OTHER

Alcoholic Neurolysis

Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age from 40 to 60 years.
* Both sexes.
* Stage 3 and 4 knee osteoarthritis in patients who aren't responding to pharmacological treatment and aren't good candidates for knee replacement surgery.

Exclusion Criteria

* Neurological disorders (Previous cerebrovascular stroke, neuropathy, or weakness).
* Bleeding disorders.
* Infection at or near the injection site.
* Presence of a pacemaker or defibrillator.
* Acute knee injury.
* Unstable knee joint.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Hesham Mahmoud Elsayed Eldamhogy

Resident of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264MS603/5/24

Identifier Type: -

Identifier Source: org_study_id

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