Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

Fatih Sultan Mehmet Training and Research Hospital

Status: Completed

Conditions: Meralgia Paresthetica

Treatments: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Ultrasound guided injection; Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04004052

ozturk84

Details and patient eligibility

About

Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), where conservative treatment options are not always sufficient.

The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral cutaneous nerve injection in the management of meralgia paresthetica by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham transcutaneous electrical nerve stimulation therapy.

Full description

In this prospective, randomized, sham-controlled study, fifty four patients (23 female and 31 male, the mean age 53.61±11.99 years) with lateral femoral cutaneous nerve compression with clinical and electrophysiological findings were enrolled. Patients were randomly assigned to three groups: 1) Ultrasound-guided injection group, 2) TENS group, 3) Sham TENS group. The blockage of the lateral femoral cutaneous nerve was performed for therapeutic meralgia paresthetica management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days a week for 2 weeks, for 20 minutes per daily session in Group 2, and sham TENS was applied to group 3 with the same protocol.

Visual Analog Scale (VAS), painDETECT questionnaire (PD-Q), Semmes Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI) and health-related quality of life (SF 36), at onset (T1), 15 days after treatment (T2) and 1 month after treatment (T3) were used for evaluation.

Enrollment: 54 patients

Sex: All

Ages: 42 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings

Exclusion criteria

• Secondary entrapment neuropathy
• Malignancy
• Pregnancy
• Infection in the inguinal region or dermatitis
• Lumbar radiculopathy
• Cardiac pacemakers
• Polyneuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

54 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Blockade of the LFCN is performed for therapeutic management of MP in group 1.

Treatment:

Other: Ultrasound guided injection

Group 2

Active Comparator group

Description:

Ten sessions of conventional TENS were applied to the group 2 daily 20 minutes per session, 5 days per week, for 2 weeks.

Treatment:

Other: Transcutaneous Electrical Nerve Stimulation (TENS)

Group 3

Sham Comparator group

Description:

Sham TENS was applied to the group 3 with the same protocol.

Treatment:

Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS)