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

A

Ankara City Hospital

Status

Active, not recruiting

Conditions

Meralgia Paresthetica

Treatments

Drug: Steroid (dexamethasone) Injection
Procedure: Pulsed Radiofrequency Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT06683924
TABED 1-24-218

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Pulsed Radiofrequency Ablation
Active Comparator group
Description:
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.
Treatment:
Procedure: Pulsed Radiofrequency Ablation
Steroid Injection
Active Comparator group
Description:
Where the lateral femoral cutaneous nerve is visible with US, 2 ml of 2% lidocaine and 2 ml (8 mg) dexamethasone will be injected.
Treatment:
Drug: Steroid (dexamethasone) Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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