A Prospective, Randomized, Double-blind, Sham-controlled Study of the Low-level Phoenix Thera-lase 42 Watt Laser in Patients With Chronic Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The Revised Symptom Impact Questionnaire
研究概览
简要总结
The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for its effects on pain, fatigue, and physical function in individuals with fibromyalgia.
详细描述
Fifty consenting participants with long-standing fibromyalgia (> 3 mo duration) will be randomized to one of two treatment groups (n=25 per group) according to a computer generated randomization table. Group 1 will be the 'sham' control group and Group 2 will be the 'active' laser treatment group. The study will be conducted in a double-blind fashion using a standard 42 watt Class IV laser which has a switch at the back of the device which allows the laser to operate in the 'inactive' mode despite giving the operator and patients the appearance of being active (e.g., generates skin warmth and a red beam of light). Treatment will be administered three times/week for three weeks. Data will be collected across the 3-week intervention and one week after completion of the intervention. Data will be analyzed with appropriate statistical methods.
The following outcome measures will be collected at baseline: (1)Standardized SF-36 questionnaire; (2) Symptom Impact Questionnaire; (3) current analgesic medication usage; (4) pressure-pain threshold testing over tender points; and (5) spinal range of motion with an inclinometer and accelerometer. Outcome measures (2) and (3) will be re-assessed during the treatment phase at the end of weeks 1, 2 and 3. At 1 week and 1 month after the last laser/sham treatment session, all baseline assessments will be repeated, in addition to a global rating of change scale. Any patient who reports any harm from the laser/sham treatments on the helpfulness scale will be queried for specific harm details.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Pre-existing medical conditions are under stable control
- •Diagnosis of fibromyalgia by Widespread Pain Index and Symptom Severity Score
- •Able to wear laser protective eyewear during the treatment session
- •Ability to speak English and complete testing
排除标准
- •Presence of another pain syndrome that has anatomical overlapping with fibromyalgia pain
- •Unstable psychiatric disorders or cognitive dysfunction or serious memory impairment
- •Previous treatment with low level laser therapy
- •Contraindication to receiving laser treatments
- •Current use of photosensitive medication (has been instructed to minimize sun exposure)
- •Active metastasis
- •Active infection
- •Impaired sensation
研究组 & 干预措施
Sham Phoenix Laser Treatment
Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy.
干预措施: Sham Phoenix Laser Treatment (Device)
Active Phoenix Laser Treatment
Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Participants in the laser treatment group will be treated at 42 watts for up to 60 seconds at tender spots in the spine or extremities. Total treatment time is not to exceed 30 minutes.
干预措施: Active Phoenix Laser Treatment (Device)
结局指标
主要结局
The Revised Symptom Impact Questionnaire
时间窗: baseline, 1 week, and 1 month after treatment
Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.
次要结局
- Global Rating of Change Scale(1 week and 1 month after treatment)
- RAND 36-Item Health Survey(baseline, 1 week, and 1 month after treatment)