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临床试验/NCT04499911
NCT04499911已完成不适用

Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica

University of Alexandria1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Isotonic dextrose 5% in water solution (Drug)

结局指标

主要结局

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

时间窗: 4 weeks

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).

次要结局

  • Patient assessment of meralgia paresthetica pain(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emmanuel Kamal Aziz Saba

Assistant professor

University of Alexandria

研究点 (1)

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