Efficacy of High-Intensity Laser Therapy in the Management of Meralgia Paresthetica: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Changes in Pain Intensity
研究概览
简要总结
This randomized controlled trial aims to investigate the efficacy of High-Intensity Laser Therapy (HILT) in the management of Meralgia Paresthetica (MP), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. Participants with MP will be randomly allocated to either the HILT or sham HILT (control) group. The study will evaluate the effects of HILT on pain intensity, functional outcomes, and quality of life. Findings from this trial will provide insights into the potential benefits of HILT as a non-invasive and safe treatment option for patients with MP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In this study, both the participants and the outcomes assessor will be blinded. Participants will be unaware of whether they are receiving active HILT or sham HILT, while the outcomes assessor will not know the treatment allocation while assessing the outcomes.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Meralgia Paresthetica, confirmed by a neurologist or a specialist in neuromuscular disorders, based on clinical signs and symptoms, and supported by nerve conduction studies.
- •Presence of pain, numbness, or tingling in the anterolateral thigh for at least three months.
- •Aged between 35 and 55 years.
- •Willing and able to provide informed consent.
- •Able to comply with the study protocol and attend all treatment sessions and follow-up assessments.
排除标准
- •Previous surgical treatment for Meralgia Paresthetica.
- •Concomitant lower back or hip pain due to other causes, such as lumbar radiculopathy, hip joint pathology, or trochanteric bursitis.
- •Presence of other neuromuscular or nerve compression disorders such as diabetic neuropathy
- •Significant trauma or surgery to the affected thigh or lumbar spine within the past six months.
- •Pregnancy or planning to become pregnant during the study period.
- •Known contraindications to High-Intensity Laser Therapy, such as active skin infection, malignancy, or photosensitivity disorders.
- •Current use of anticoagulant medications or immunosuppressive therapy.
结局指标
主要结局
Changes in Pain Intensity
时间窗: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
The secondary outcome measure is the change in pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a self-reported scale ranging from 0 (no pain) to 10 (worst pain imaginable). A reduction in NPRS scores indicates a decrease in pain intensity.
次要结局
- Changes in Lateral Femoral Cutaneous Nerve Distal Latency(Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups)
- Changes in Functional Outcomes(Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups)
- Changes in Quality of Life(Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University