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

NCT06683924 | Completed

• 1 other identifier: TABED 1-24-218
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meralgia Paresthetica

Keywords

meralgia paresthetica; pulsed radiofrequency ablation; lateral femoral cutaneous nerve

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The patients' pain levels were assessed using the Visual Analog Scale (VAS). The VAS pain score was scored as "no pain" (score=0) and "worst pain" (score=10).

  Baseline, 1st day, 2nd week, 3rd month, 6th month

Secondary Outcomes (1)

• The Leeds Assessment of Neuropathic Symptoms and Signs pain scale

  Baseline, 1st day, 2nd week, 3rd month, 6th month

Study Arms (2)

Pulsed Radiofrequency Ablation

ACTIVE COMPARATOR

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.

Steroid Injection

ACTIVE COMPARATOR

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

Drug: Steroid (dexamethasone) Injection

Interventions

Pulsed Radiofrequency Ablation PROCEDURE

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.

Steroid (dexamethasone) Injection 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.

Steroid Injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 7063571 RESULT

• 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.

  PMID: 30013736 RESULT

• 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.

  PMID: 32022852 RESULT

• 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.

  PMID: 27543938 RESULT

MeSH Terms

Conditions

Femoral Neuropathy

Interventions

Steroids; Dexamethasone; Injections

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ayşe Merve Ata, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: October 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2024-11

Locations

TU (1)