Meralgia Paresthetica Clinical Trial
Official title:
Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
Verified date | August 2020 |
Source | University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
University of Alexandria |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Patient assessment of meralgia paresthetica pain | Patient assessment of meralgia paresthetica pain was evaluated by using visual analogue scale. It is a 10-cm horizontal scale which range from 0 (no pain), to 10 (severe intolerable pain). | 4 weeks |
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