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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03864770
Study type Interventional
Source China Medical University Hospital
Contact LI-Wei Chou, PhD
Phone +886-4-22052121
Email chouliwe@gmail.com
Status Recruiting
Phase N/A
Start date March 5, 2019
Completion date February 4, 2020

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05547750 - Effect of Vitamin K2 in the Treatment of Nocturnal Leg Cramps in Older Population N/A
Completed NCT02548507 - Nocturnal Leg Cramps in Geneva : an Observational Study
Completed NCT01804556 - The Effects of the Myofascial Trigger Point Injections on Pain and Sleep Disturbance in Patients With Nocturnal Leg Cramps With Trigger Points on Gastrocnemius Muscle N/A
Completed NCT03807219 - The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC N/A
Terminated NCT01709968 - Magnesium Oxide Monohydrate for Nocturnal Leg Cramps Phase 4
Enrolling by invitation NCT04789811 - Exercise and Dry Needling Treatment Combination in Nocturnal Calf Cramps N/A