- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06683924
Pulsed Radiofrequency Ablation and Steroid Injections for the Treatment of Meralgia Paresthetica
November 13, 2025 updated by: Ayşe Merve Ata, Ankara City Hospital Bilkent
Comparison of Pulsed Radiofrequency Ablation and Steroid Injections of The Lateral Femoral Cutaneous Nerve for The Treatment of Meralgia Paresthetica
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Active Comparator: 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.
|
Where the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline, 1st day, 2nd week, 3rd month, 6th month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Leeds Assessment of Neuropathic Symptoms and Signs pain scale
Time Frame: Baseline, 1st day, 2nd week, 3rd month, 6th month
|
The Leeds Assessment of Neuropathic Symptoms and Signs pain scale will be used to assess the presence of neuropathic pain.
It consists of two subcategories: pain questionnaire and sensory assessment.
The questionnaire consists of five questions about general pain symptoms of the patient, and two questions, that are answered after appropriate clinical examination following predetermined methodology, which includes the seek for allodynia and altered pinprick threshold Scoring varies between 0 and 24 points, with a total score > 12 indicating pain predominantly of neuropathic etiology.
|
Baseline, 1st day, 2nd week, 3rd month, 6th month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşe Merve Ata, MD, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Actual)
August 1, 2025
Study Completion (Actual)
November 1, 2025
Study Registration Dates
First Submitted
November 9, 2024
First Submitted That Met QC Criteria
November 9, 2024
First Posted (Actual)
November 12, 2024
Study Record Updates
Last Update Posted (Actual)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 13, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Mononeuropathies
- Femoral Neuropathy
- Therapeutics
- Drug Administration Routes
- Drug Therapy
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Fused-Ring Compounds
- Steroids, Fluorinated
- Pregnadienetriols
- Dexamethasone
- Injections
- Steroids
Other Study ID Numbers
- TABED 1-24-218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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