Pulsed Radiofrequency Ablation and Steroid Injections for the Treatment of Meralgia Paresthetica

NCT ID: NCT06683924

Last Updated: 2025-11-17

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-11-01

Brief Summary

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Meralgia Paresthetica (MP) is a mononeuropathy of the lateral femoral cutaneous nerve (LFCN), characterized by pain, numbness, hyperesthesia, or hypoesthesia, especially in the anterolateral thigh where the nerve has a sensory distribution. TheLFCN passes between the psoas and quadratus lumborum muscles in the iliac fossa and enters the thigh under the inguinal ligament by passing through the anterior superior iliac spine over the iliacus muscle. It superficially spreads over the sartorius muscle and receives sensation in the anterolateral thigh. Ultrasonography (US) is frequently used by physiatrists in the diagnosis and interventional treatment of musculoskeletal diseases. MP is usually diagnosed with clinical symptoms such as burning, tingling, pain, and dysesthesia in the anterolateral thigh. Electromyography, US, and magnetic resonance imaging are helpful in diagnosis. US is an easy-to-apply, inexpensive method in daily practice, providing great comfort to clinicians in determining etiology and differential diagnosis. Treatment may include patient education, avoiding tight belts, losing weight, conservative treatment methods, use of non-steroidal anti-inflammatory drugs, local anesthetic and/or steroid injections, surgical neurectomy, neurolysis or transpositions. However, in recent years, there have been case series showing that radiofrequency ablation (RF) can also be applied. The aim of this study is to compare the effectiveness of RF ablation of the lateral femoral cutaneous nerve with steroid injection in patients with clinically diagnosed MP and confirmed by US.

Detailed Description

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Conditions

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Meralgia Paresthetica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pulsed Radiofrequency Ablation

The area where the lateral femoral cutaneous nerve is seen with US will be anesthetized with 1 ml of 1% lidocaine and a 22 Gauge, 10 cm-5 mm RF cannula will be inserted. Sensory fibers will be stimulated with 0.3-0.5 V. Then, motor fibers will be stimulated up to 1.5 V. If no motor contraction is seen, LFCN will be ablated at 42 degrees Celsius for 240 seconds. The procedure will be completed with the injection of 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone through the RF cannula.

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

Steroid Injection

Where the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected.

Group Type ACTIVE_COMPARATOR

Steroid (dexamethasone) Injection

Intervention Type DRUG

Where the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected.

Interventions

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Pulsed Radiofrequency Ablation

The area where the lateral femoral cutaneous nerve is seen with US will be anesthetized with 1 ml of 1% lidocaine and a 22 Gauge, 10 cm-5 mm RF cannula will be inserted. Sensory fibers will be stimulated with 0.3-0.5 V. Then, motor fibers will be stimulated up to 1.5 V. If no motor contraction is seen, LFCN will be ablated at 42 degrees Celsius for 240 seconds. The procedure will be completed with the injection of 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone through the RF cannula.

Intervention Type PROCEDURE

Steroid (dexamethasone) Injection

Where the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with numbness, tingling and pain in the anterolateral thigh region
* Patients with edematous LFCN observed on ultrasound and diagnosed with MP and with complaints resistant to conservative treatment
* Being literate

Exclusion Criteria

* History of lumbar discopathy or history of discopathy surgery
* Cardiac pacemaker
* History of bilateral hip, knee, foot and lumbar region fractures
* History of previous hip and knee surgery
* Fixed joint contracture in the lower extremity
* History of malignancy and chemotherapy or radiotherapy
* Presence of any neuromuscular disease
* Progressive or non-progressive central and peripheral nervous system disease
* Patients in pregnancy and lactation
* Bleeding diathesis, INR\>1.2
* Uncontrolled diabetes or other serious comorbidities
* Allergy to drugs or materials used
* Local infections or sepsis
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Merve Ata

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşe Merve Ata, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Mackinnon SE, Hudson AR, Gentili F, Kline DG, Hunter D. Peripheral nerve injection injury with steroid agents. Plast Reconstr Surg. 1982 Mar;69(3):482-90. doi: 10.1097/00006534-198203000-00014.

Reference Type RESULT
PMID: 7063571 (View on PubMed)

Ghai B, Dhiman D, Loganathan S. Extended duration pulsed radiofrequency for the management of refractory meralgia paresthetica: a series of five cases. Korean J Pain. 2018 Jul;31(3):215-220. doi: 10.3344/kjp.2018.31.3.215. Epub 2018 Jul 2.

Reference Type RESULT
PMID: 30013736 (View on PubMed)

Abd-Elsayed A, Gyorfi MJ, Ha SP. Lateral Femoral Cutaneous Nerve Radiofrequency Ablation for Long-term Control of Refractory Meralgia Paresthetica. Pain Med. 2020 Nov 7;21(7):1433-1436. doi: 10.1093/pm/pnz372.

Reference Type RESULT
PMID: 32022852 (View on PubMed)

Lee SH, Shin KJ, Gil YC, Ha TJ, Koh KS, Song WC. Anatomy of the lateral femoral cutaneous nerve relevant to clinical findings in meralgia paresthetica. Muscle Nerve. 2017 May;55(5):646-650. doi: 10.1002/mus.25382. Epub 2017 Jan 3.

Reference Type RESULT
PMID: 27543938 (View on PubMed)

Other Identifiers

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TABED 1-24-218

Identifier Type: -

Identifier Source: org_study_id

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