The Effectiveness of Low-Level Laser Therapy in the Treatment of Meralgia Paresthetica
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain will be assessed with Visual Analog Scale.
研究概览
简要总结
Patients diagnosed with meralgia paresthetica via electromyography (EMG), who present with neuropathic complaints on the lateral thigh to the Physical Medicine and Rehabilitation outpatient clinics of our hospital, will be included in the study after reviewing exclusion criteria. Patients will be randomized into two equal groups using a sealed-envelope system. The treatment group will receive low-level laser therapy (LLLT) combined with simultaneous transcutaneous electrical nerve stimulation (TENS), while the control group will receive placebo laser therapy combined with simultaneous TENS.
An LED gallium-aluminum-arsenide (Ga-Al-As) diode laser device with a power of 1.6 W and a wavelength of 808 nm will be used in the study. The treatment will consist of 10 sessions, applied over two weeks, five days per week.
Demographic data (age, gender, body mass index, and occupation) of all patients included in the study will be recorded. Pain and functional impairment will be evaluated using the VAS, SF-36, PSQI, and S-LANSS scales for all patients. VAS, SF-36, PSQI, and S-LANSS scores will be assessed at the end of the treatment and on the 30th day after treatment completion (6th-week after baseline). The effectiveness of low-level laser therapy will be investigated using statistical data analysis methods.
Low-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms. In the control group, sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas.
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
Patients in the first group will receive low-level laser therapy, while patients in the second group will receive sham low-level laser therapy. Participants will not be informed about which group they are in. In addition, the outcome assessors will also conduct their assessments blinded to the groups to which the patients belong.
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
- 否
入选标准
- •Patients aged 18 to 70 with neuropathic complaints in the anterolateral thigh, whose diagnosis has been confirmed by sensory conduction studies of the lateral femoral cutaneous nerve.
排除标准
- •Patients with diabetes mellitus
- •Patients with polyneuropathy
- •Patients with radicular pain
- •Patients receiving treatment for neuropathic pain
- •Patients who have received an injection to the lateral femoral cutaneous nerve within the last three months
- •Patients who have undergone physical therapy modalities for a diagnosis of meralgia paresthetica within the last three months
- •Patients with a history of pelvic surgery
- •Patients diagnosed with rheumatologic diseases
- •Pregnant women
- •Patients with active skin infections
- •Malignancy
- •Fibromyalgia
研究组 & 干预措施
Group 1: LOW LEVER LASER THERAPY AND TENS
Low-level laser therapy will be applied perpendicularly at four different points, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Other)
Group 1: LOW LEVER LASER THERAPY AND TENS
Low-level laser therapy will be applied perpendicularly at four different points, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region
干预措施: Low-Level Laser Therapy (Other)
Group 2: SHAM LASER AND TENS THERAPY
Sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas. TENS electrodes will be placed on the painful anterolateral thigh region
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Other)
结局指标
主要结局
Pain will be assessed with Visual Analog Scale.
时间窗: It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
次要结局
- Neuropathic pain will be assessed using the S-LANSS scale.(It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.)
- General health status will be assessed with Short Form 36.(It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.)
- Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).(It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.)
研究者
Merve Sade Dağdeviren
Medical Doctor
Istanbul Training and Research Hospital
