Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2015-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Meralgia Paresthetica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

Ultrasound guided injection

Intervention Type OTHER

Group 2

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

Group Type ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type OTHER

Group 3

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

Group Type SHAM_COMPARATOR

Sham Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type OTHER

Interventions

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Ultrasound guided injection

Intervention Type OTHER

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type OTHER

Sham Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

42 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No