Effectiveness of Extracorporeal Shockwave Therapy on the Patients With Nocturnal Leg Cramps - Possible Related to Myofascial Trigger Point in the Gastrocnemius Muscle
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The frequency of nocturnal leg cramps (FC)
研究概览
简要总结
Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The investigator performed extracorporeal shock wave therapy (ESWT). This experiment used a randomized experiment to assess the immediate, short-term and long-term effects of extracorporeal shock wave therapy on patients with nocturnal leg cramps.
详细描述
Nocturnal leg cramps (NLCs) are often described as a symptom of sudden and involuntary muscle contraction at night, which often affects sleep quality due to pain and tight discomfort in the thigh, calf and foot. The pathophysiology of nocturnal leg cramps is unclear, but it is generally considered to be associated with excitability lower motor neurons, sleep posture at night, leg muscle fatigue, nerve disability or damage (eg, Parkinson's disease), metabolic diseases (eg : hyperphosphatemia). Generally, quinine or magnesium oxide is the most commonly used pharmacological treatment. The common non-drug treatments are stretching exercise, massage or hot therapy, but there is not enough evidence to indicate which treatment is specific effective.
In a previous study, they proposed that nocturnal leg cramps may be associated with myofascial trigger points (MTrPs) of the gastrocnemius. Other studies have also proposed that extracorporeal shock wave therapy (ESWT) applying to the MTrPs of the upper trapezius muscle could improve cervicogenic headache. We will conduct a randomized parallel study to investigate the efficacy of ESWT on nocturnal leg cramps. Participants will be randomized into two groups: one is only general physical therapy (gPT) and the other one is ESWT + gPT.
The outcome measurement tools including the frequency of nocturnal leg cramps, visual analog scale (VAS), pain pressure threshold (PPT) and muscle tone in the gastrocnemius, range of motion of knee and ankle, and quality of sleep questionnaire were used to compare two groups with regard to the pain intensity, quality of sleep, and overall satisfaction in subjects with nocturnal leg cramps.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20 y/o patients with NLCs: (1) 4 times/week, last 2 weeks; (2) Occurred in nighttime or resting time of daytime
- •Patients with MTrPs on gastrocnemius (According to the diagnostic criteria proposed by Simons & Travell)
排除标准
- •(1) Taking medication for leg cramps (eg. Quinine, Magnesium oxide); (2) Other drugs that affect research and evaluation (eg. diuretics, statins, calcium channel blockers, anticonvulsants)
- •Congenital lower limb musculoskeletal diseases, Lower limb or spine surgery
- •Uncommunicated or cognitive impaired
- •Patients refused to be recruited
研究组 & 干预措施
Extracorporeal shock wave therapy and general physical therapy
In this arm, the subjects will receive the intervention of extracorporeal shock wave therapy and general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.
干预措施: Extracorporeal shock wave therapy (Device)
Extracorporeal shock wave therapy and general physical therapy
In this arm, the subjects will receive the intervention of extracorporeal shock wave therapy and general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.
干预措施: General physical therapy (Procedure)
Only general physical therapy
In this arm, the subjects will only receive the intervention of general physical therapy 3 times a week for 2 weeks, in total 6 times treatments and will be arrange to take efficacy two assessment on 1 week and 2 weeks after 6 times treatments separately.
干预措施: General physical therapy (Procedure)
结局指标
主要结局
The frequency of nocturnal leg cramps (FC)
时间窗: 1 day
Ask participants to describe the frequency of nocturnal leg cramps (NLCs) in the last week. The frequency of occurrence is recorded on an average of several times a day (times/day). The frequency of nocturnal leg cramps (FC) can be used as a tracking and indicator of treatment.
次要结局
- Visual Analog Scales (VAS)(1 day)
- Pressure Pain Threshold (PPT)(1 day)
- Range of Motion of knee and ankle joint(1 day)
- Muscle tone(1 day)
- Pittsburgh sleep quality index (PSQI)(1 day)
研究者
Li-Wei Chou
Minister of Rehabilitation
China Medical University Hospital
