Meralgia ParestheticaNCT06683924
Pulsed Radiofrequency Ablation and Steroid Injections for the Treatment of Meralgia Paresthetica
A study testing Pulsed Radiofrequency Ablation and Steroid (dexamethasone) Injection in people with Meralgia Paresthetica, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Meralgia Paresthetica
- What is being tested?
- Pulsed Radiofrequency Ablation and Steroid (dexamethasone) Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Meralgia Paresthetica
- Being tested
- Pulsed Radiofrequency Ablation, Steroid (dexamethasone) Injection
- Keywords
- meralgia paresthetica, pulsed radiofrequency ablation, lateral femoral cutaneous nerve
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency AblationProcedure or surgery
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) InjectionDrug
Where the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Steroid (dexamethasone) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1st day, 2nd week, 3rd month, 6th month
Secondary outcomes (1)
The Leeds Assessment of Neuropathic Symptoms and Signs pain scale
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.
Measured: Baseline, 1st day, 2nd week, 3rd month, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Aug 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Meralgia ParestheticaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Merve Ata, Ankara City Hospital Bilkent
- Investigators
- Ayşe Merve Ata, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683924
- Sponsor's protocol ID
- TABED 1-24-218
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 7063571Ghai 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.
PubMed 30013736Abd-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.
PubMed 32022852Lee 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.
PubMed 27543938
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulsed Radiofrequency Ablation and Steroid Injections of The Lateral Femoral Cutaneous Nerve for The Treatment of Meralgia Paresthetica
- ClinicalTrials.gov ID
- NCT06683924
- Acronym / sponsor ID
- TABED 1-24-218
- Conditions
- Meralgia Paresthetica
- Keywords
- meralgia paresthetica, pulsed radiofrequency ablation, lateral femoral cutaneous nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Steroid (dexamethasone) InjectionWhere the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Radiofrequency AblationThe 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. | Procedure or surgery | – |
| Steroid (dexamethasone) InjectionWhere 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 Injection |
Primary outcome
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).
1 secondary outcome
The Leeds Assessment of Neuropathic Symptoms and Signs pain scale
Time frame: Baseline, 1st day, 2nd week, 3rd month, 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 7063571Mackinnon 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.
- Results publication: PubMed 30013736Ghai 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.
- Results publication: PubMed 32022852Abd-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.
- Results publication: PubMed 27543938Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Merve Ata, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency Ablation and Steroid (dexamethasone) Injection in people with Meralgia Paresthetica, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline, 1st day, 2nd week, 3rd month, 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683924, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.