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Clinical Trials/NCT06683924
NCT06683924CompletedNot Applicable

Comparison of Pulsed Radiofrequency Ablation and Steroid Injections of The Lateral Femoral Cutaneous Nerve for The Treatment of Meralgia Paresthetica

Ankara City Hospital Bilkent1 site in 1 country22 target enrollmentStarted: October 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Visual Analog Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Steroid (dexamethasone) Injection (Drug)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • The Leeds Assessment of Neuropathic Symptoms and Signs pain scale(Baseline, 1st day, 2nd week, 3rd month, 6th month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ayşe Merve Ata

MD, Principal Investigator

Ankara City Hospital Bilkent

Study Sites (1)

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