Treatment of Chronic Myofascial Pain Syndrome Over Neck by Using Intravascular Laser Irradiation of Blood
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Myofascial pain syndrome (MPS) is characterized by single or multiple trigger points (TrP) in taut bands within the affected muscles. Chronic MPS over neck is prevalent and responsible for markedly loss of work-day and a reduction of quality of life.
Intravascular laser irradiation of blood (ILIB) involves in vivo illumination of the blood by low-level laser light through an optical fiber inserted in a vein. Researches disclosed that ILIB reduced blood viscosity, enhanced erythrocyte deformity, and increased oxygen saturation in blood. However, no research studies the effectiveness of ILIB to treat MPS.
Real-time sonoelastography (RTS) and shear wave velocity (SWV) are used to detect the stiffness of skeletal muscles. RTS is displayed as a color-coded graphic to represent the relative stiffness of structures. For a given material, faster SWV indicates the greater stiffness. To our knowledge, only one research using RTS and SWV to study MPS.
To elucidate the effectiveness of ILIB to treat chronic MPS over neck, and the validity of RTS and SWV for MPS, we conducted this study.
详细描述
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Time interval of the study: from 2014-11-1 to 2016-10-31 2. Participants and sample size:
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Participants: Patients having chronic MPS over neck were randomized allocated to experimental group or control group. Participants in both groups are evaluated before and after the interventions (week 0 and week 2 respectively), and 12 week after the intervention (week 14). Both participants and evaluators don't know the allocation.
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Sample size: thirty-six participants. The investigators plan to recruit 18 participants in each year.
III. Intervention:
Participants in experimental group receive ILIB (He-Ne laser, wavelength 632.8nm) with output power 0.3mW for 60minutes and following transcutaneous electric nerve stimulation (TENS) and stretching exercise every day except weekend for 2 weeks. Participants in control group receive sham therapies with the same protocol but no laser energy output
IV.Outcome Measures:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) age ≧ 18 years old; (2) willing to sign an inform consent; (3) having a chronic MPS over neck at least 6 months. The diagnosis of MPS was made while the following criteria are met: (a) recognized pain with exquisite spot tenderness on a palpable taut band over the pain area; (b) presence of one of the two confirmatory signs: referred pain and local twitch response
排除标准
- •(1) pregnancy; (2) bleeding tendency; (3) active systemic infective or inflammatory disease; (4) major surgery or trauma in the recent 3 months; (5) unstable cervical spine; (6) rheumatoid arthritis34; (7) open wound over neck; (8) pace-maker or defibrillator implantation; (9) overt neuropathic pain or radiation pain; (10) inability to express pain or quality of life.
结局指标
主要结局
Pain
时间窗: week 0, week 2, week 14
Pain as measured by using a 10-cm long visual analogue scale (0 indicates no pain while 10 indicates worst pain) at rest and at movement.
次要结局
- Pressure pain threshold (PPT)(week 0, week 2, week 14)
- Shear wave velocity (SWV)(week 0, week 2, week 14)
- Real-time sonoelastography (RTS)(week 0, week 2, week 14)
- World Health Organization Quality of Life Questionnaire Short Form Taiwan Version: WHOQOL - BREF Taiwan Version(week 0, week 2, week 14)