Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica

NCT04499911 | Completed

• 1 other identifier: 0303901
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Meralgia paresthetica is an entrapment neuropathy of the lateral femoral cutaneous nerve. Its main manifestation is neuropathic pain on the lateral aspect of the thigh. Neural prolotherapy has shown improvement and relieve of neuropathic pain. The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous perineural injection of dextrose 5% solution) on reliving pain and improvement of function and quality of life in patients with meralgia paresthetica.

Conditions

Meralgia Paresthetica

Keywords

Meralgia paresthetica; Neural Prolotherapy; lateral femoral cutaneous nerve

Outcome Measures

Primary Outcomes (1)

• Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)

  Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia) by using visual analogue scale were evaluated collectively by using VAS. It is a 10-cm horizontal scale) which range from 0 (no meralgia paresthetica symptoms), to 10 (severe intolerable symptoms).

  4 weeks

Secondary Outcomes (1)

• Patient assessment of meralgia paresthetica pain

  4 weeks

Study Arms (1)

Neural prolotherapy

EXPERIMENTAL

Neural prolotherapy using isotonic dextrose 5% in water solution (about 5 ml). The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.

Drug: Isotonic dextrose 5% in water solution

Interventions

Isotonic dextrose 5% in water solution DRUG

The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.

Also known as: Subcutaneous nerual prolotherapy

Neural prolotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients had clinical evidence of meralgia paresthetica which was based on the following: (i) the presence of pain, paraesthesia and numbness over the anterior and lateral aspect of the thigh; (ii) exacerbation of these symptoms on walking, standing and hip extension; and (iii) meralgia paresthetica was confirmed electrophysiologically by nerve conduction study with or without somatosensory evoked potentials.
• The symptoms needed to be present for at least three months.
• The patients should be unresponsive to conservative treatment. The conservative treatment included lifestyle modification including weight reduction, activity modification (avoid the use of seat belts) and avoidance of tight underwear (tight garments such as jeans, uniforms); non-steroidal anti-inflammatory drugs and anticonvulsants for neuropathic pain; and physiotherapy.

You may not qualify if:

• Diabetes mellitus.
• Endocrine disorders.
• Metabolic disorders.
• Systemic rheumatologic disorders.
• Neurological disorders including peripheral neuropathy, lumbar radiculopathy and lumbar plexopathy.
• Coagulopathy.
• Anticoagulant treatment.
• Current skin or soft tissue infection at or near the site of injection.
• Prior local injection of corticosteroid in the past year for meralgia paresthetica.
• Prior neural prolotherapy in the past year for meralgia paresthetica.
• Prior surgery in the affected thigh region.
• Patients presented with a systemic active inflammatory condition or infection.
• Pregnancy.
• Patients refused to participate in the study

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Femoral Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Emmanuel K Saba, MD

  Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: August 5, 2020
• Study Start: April 15, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)