NCT03864770

Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps

Effectiveness of Extracorporeal Shockwave Therapy on the Patients With Nocturnal Leg Cramps - Possible Related to Myofascial Trigger Point in the Gastrocnemius Muscle

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Nocturnal Leg Cramps

Interventions

Type	Name	Description
DEVICE	Extracorporeal shock wave therapy	Extracorporeal shock wave therapy is a mechanical sound wave that generates energy by extremely high-frequency vibration to compress the medium. Low-energy extracorporeal shock waves can be used for cell regeneration and pain control therapy; medium-high energy can be used to treat patients with poor bone healing; high-energy can be used to lithotrite. In recent years, extracorporeal shock waves have been applied on the musculoskeletal diseases, such as: epicondylitis, plantar fasciitis, chronic pelvic pain, chronic heel pain syndrome, lymphedema, burns, pressure sores, calcific tendinitis and myofascial pain syndrome. This treatment is a non-invasive and safe treatment.
PROCEDURE	General physical therapy	The general physical therapies such as: thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle.

Timeline

• Start date: 2019-03-05
• Primary completion: 2019-12-05
• Completion: 2020-02-04
• First posted: 2019-03-06
• Last updated: 2019-03-11

Locations

1 site across 1 country: Taiwan