Therapeutic Effects of Monochromatic Infrared Energy Therapy on Patients With Chronic Low Back Pain: A Double-Blind, Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- changes of pain
研究概览
简要总结
To investigate the effects of short-term and medium-term monochromatic infrared energy therapy on patients with chronic low back pain (LBP) according to the International Classification of Functioning, Disability and Health.
详细描述
Methods：70 participants with chronic LBP will be included. Participants received six 40-min sessions of hot pack therapy combined active or placebo monochromatic infrared energy therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliwatt/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration. Patients will be assessed at before treatment and follow-up assessments, including after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months, respectively, after treatment is terminated.
Main Outcome Measures: Patients will be assessed periodically with pain, Multidimensional Fatigue Inventory, postural stability (using the postural stability evaluation system: Biodex Stability System), and Fear-Avoidance Behavior Questionnaire.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants with chronic low back pain
排除标准
- •low back pain accompanied by specific pathological conditions, such as an infection,inflammation, rheumatoid arthritis, fracture, or tumor;
- •a self-reported history of malignancy, vertigo, stroke, or other condition that may impair postural stability;
- •a history of low back surgery with an implant;
- •pregnancy or plans to become pregnant during the course of the study;
- •having received concurrent treatment for low back pain by another health care professional
结局指标
主要结局
changes of pain
时间窗: participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment
Participants received six 40-min sessions of hot pack therapy combined active or placebo monochromatic infrared energy therapy over the low back (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2) followed by 20-min supervised therapeutic exercise, for 3 times per week for a 4-week duration.
次要结局
- changes of Multidimensional Fatigue Inventory(participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment)
- changes of postural stability(participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment)
- changes of fear avoidance behavior(participants will be evaluated at before treatment, and followed at treatment for 2 and 4 weeks, and 1 and 3 months after treatment)
研究者
Ru-Lan Hsieh
Associate Professor
Taipei Medical University