High-intensity Laser Therapy Improves Pain, Health Status and Quality of Life in Women With Fibromyalgia: A Single Blinded-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This study will be conducted to investigate High-intensity laser therapy improves pain, health status and quality of life in women with fibromyalgia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between > 3-6/19 and SSS > 9/12
- •symptoms have been present at a similar level for at least 3 months
- •the patient does not have another disorder that would otherwise sufficiently explain the pain
- •generalized pain, defined as pain in at least four of five regions, is present
排除标准
- •uncontrolled diabetes
- •known history of cancer
研究组 & 干预措施
traditional exercise therapy only
This 50-minute program included a 10-minute warm-up phase (treadmill walking at a comfortable speed), 30 minutes of stretching exercises for (glutei, paraspinal muscles, hamstring, pectoralis, scalenus, intercostal muscles, and trapezius), and a 10-minute cool-down involving self-stretching and respiratory exercises.
干预措施: traditional exercise therapy only (Device)
HILT alongside traditional exercise therapy,
pulsed Nd: YAG laser device (HIRO 3.0; ASA Laser, Arcugnano, Italy). This equipment delivers pulsed laser light at a wavelength of 1,064 nm, with a very high peak power of 3 kW and energy density ranging from 360 to 1,780 mJ/cm2.
干预措施: traditional exercise therapy only (Device)
HILT alongside traditional exercise therapy,
pulsed Nd: YAG laser device (HIRO 3.0; ASA Laser, Arcugnano, Italy). This equipment delivers pulsed laser light at a wavelength of 1,064 nm, with a very high peak power of 3 kW and energy density ranging from 360 to 1,780 mJ/cm2.
干预措施: HILT alongside traditional exercise therapy (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: up to 6 weeks
10 cm, where patients rated their pain on a scale from 0 ("no pain") to 10 ("extremely severe pain ") over the past 3 days
Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: up to 6 weeks
assesses the overall severity of FM and health status based on participant ratings. It encompasses three key domains similar to the FIQ (function, overall impact, and symptoms), with additional inquiries regarding memory, tenderness, balance, and environmental sensitivity
pressure algometer
时间窗: up to 6 weeks
This tool comprises a circular rubber tip (1 cm2) and a pressure gauge for displaying readings in kilograms. Given the rubber tip's 1 cm² area, measurements were reported in kilograms per square centimeter (kg/cm2). The algometer has a measurement range from 0 to 10 kg, with increments of 0.1 kg. The instrument was pressed against the skin's surface at a right angle, and the force exerted was registered on a manometer.
次要结局
未报告次要终点
研究者
Kerolous Ishak Shehata
principle investigator
October 6 University