Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica (NCT04499911) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica
Egypt15 participantsStarted 2018-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)