Clinical trial NCT06683924: Pulsed Radiofrequency Ablation and Steroid Injections for the Treatment of Meralgia Paresthetica
Official title: Comparison of Pulsed Radiofrequency Ablation and Steroid Injections of The Lateral Femoral Cutaneous Nerve for The Treatment of Meralgia Paresthetica
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Meralgia Paresthetica
Keywords: meralgia paresthetica
pulsed radiofrequency ablation
lateral femoral cutaneous nerve
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Baseline, 1st day, 2nd week, 3rd month, 6th month
Secondary outcomes:
measure: The Leeds Assessment of Neuropathic Symptoms and Signs pain scale
timeFrame: Baseline, 1st day, 2nd week, 3rd month, 6th month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Ayşe Merve Ata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.