Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica

NCT ID: NCT04499911

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2019-09-30

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.

Detailed Description

Meralgia paresthetica is a mononeuropathy of the lateral femoral cutaneous nerve (i.e. lateral cutaneous nerve of the thigh). It is known as the lateral cutaneous nerve of the thigh neuralgia. It is due to a lot of etiologies. It is characterized by neuropathic pain, tingling, paresthesia and numbness in the anterolateral aspect of the thigh. The symptoms may be provoked or worsened by prolonged standing and walking. Sitting may alleviate the pain because there is reduction of the tension over the nerve, The treatment of meralgia paresthetica is directed towards the improvement of the symptoms which is mainly pain with subsequent improvement of function and quality of life, as well as, treatment of the etiology. The treatment includes conservative and surgical treatment. Conservative treatment consists of non-pharmacologic treatment and pharmacologic treatment. Surgical treatment takes place in case of failure of the conservative treatment. Surgical options consist of neurolysis and neurectomy.

Neural prolotherapy was reported to improve and relieve of neuropathic pain including that of meralgia paresthetica. Neural prolotherapy is the subcutaneous perineural injection of isotonic dextrose (5%) solution especially at the points of fascial penetration of the sensory nerve. It is the site where the sensory nerve reaches the subcutaneous plane. There are scanty studies assessed this issue.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neural prolotherapy

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.

Group Type: EXPERIMENTAL

Isotonic dextrose 5% in water solution

Intervention Type: 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.

Interventions

Isotonic dextrose 5% in water solution

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.

Intervention Type: DRUG

Other Intervention Names

Subcutaneous nerual prolotherapy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Emmanuel Kamal Aziz Saba

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emmanuel K Saba, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Faculty of Medicine, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0303901

Identifier Type: -

Identifier Source: org_study_id