Conservative Treatment Versus Ultrasound Guided Injection in Management of Meralgia Paresthetica: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), where conservative treatment options are not always sufficient.
The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral cutaneous nerve injection in the management of meralgia paresthetica by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham transcutaneous electrical nerve stimulation therapy.
详细描述
In this prospective, randomized, sham-controlled study, fifty four patients (23 female and 31 male, the mean age 53.61±11.99 years) with lateral femoral cutaneous nerve compression with clinical and electrophysiological findings were enrolled. Patients were randomly assigned to three groups: 1) Ultrasound-guided injection group, 2) TENS group, 3) Sham TENS group. The blockage of the lateral femoral cutaneous nerve was performed for therapeutic meralgia paresthetica management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days a week for 2 weeks, for 20 minutes per daily session in Group 2, and sham TENS was applied to group 3 with the same protocol.
Visual Analog Scale (VAS), painDETECT questionnaire (PD-Q), Semmes Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI) and health-related quality of life (SF 36), at onset (T1), 15 days after treatment (T2) and 1 month after treatment (T3) were used for evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings
排除标准
- •Secondary entrapment neuropathy
- •Malignancy
- •Pregnancy
- •Infection in the inguinal region or dermatitis
- •Lumbar radiculopathy
- •Cardiac pacemakers
- •Polyneuropathy
结局指标
主要结局
Visual Analog Scale
时间窗: 1 months
The VAS was used to record each patient's current level of pain with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced. Using a ruler marked in centimeters, the examiner obtained the exact values along a 10-cm VAS line.
Semmes-Weinstein monofilament test
时间窗: 1 months
Cutaneous pressure threshold was measured by touch test using a device with nylon Semmes-Weinstein monofilaments (SWMt) embedded in a plastic handle. A small pushing force is applied anterolateral femoral skin area for 1-1,5 seconds to push the filaments. A medical staff member presses the filaments at an angle of approximately 90° against the patient's thigh. This test is useful for medical staff because it is simple and easy. The threshold was defined as the lightest filament that the subject responses correctly at least two out of the three trials. The filaments are labeled with a numerical marking, which is a log to the base ten of the force in tenth of milligrams. Applications was made where the most symptoms has been observed in the patient's anterolateral thigh.
painDETECT questionnaire
时间窗: 1 months
It consists of seven items evaluating pain qualities, one evaluating the course of pain, and one evaluating pain radiation. Additionally, the questionnaire contains three numerical rating scales (NRSs) of 0-10 for current, worst, and average pain severity. An overall score is generated that summarizes everything but the pain intensity NRS, which ranges between -1 and 38. An overall score of \>18 indicates likely Neuropathic pain, 13-18 possible Neuropathic pain, and \< 13 unlikely Neuropathic pain.
次要结局
- Short Form (SF-36) Health Questionnaire(1 months)
- Pittsburgh Sleep Quality Index (PSQI)(1 Months)