Clinical trial NCT03864770: Extracorporeal Shock Wave Therapy Treatment for Nocturnal Leg Cramps
Official title: Effectiveness of Extracorporeal Shockwave Therapy on the Patients With Nocturnal Leg Cramps - Possible Related to Myofascial Trigger Point in the Gastrocnemius Muscle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nocturnal Leg Cramps
Keywords: myofascial trigger points
nocturnal leg cramps
extracorporeal shock wave therapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. ≥ 20 y/o patients with NLCs: (1) 4 times/week, last 2 weeks; (2) Occurred in nighttime or resting time of daytime
2. Patients with MTrPs on gastrocnemius (According to the diagnostic criteria proposed by Simons \& Travell)

Exclusion Criteria:

1. (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)
2. Congenital lower limb musculoskeletal diseases, Lower limb or spine surgery
3. Uncommunicated or cognitive impaired
4. Patients refused to be recruited

Primary outcomes:
measure: The frequency of nocturnal leg cramps (FC)
timeFrame: 1 day
Secondary outcomes:
measure: Visual Analog Scales (VAS)
timeFrame: 1 day
measure: Pressure Pain Threshold (PPT)
timeFrame: 1 day
measure: Range of Motion of knee and ankle joint
timeFrame: 1 day
measure: Muscle tone
timeFrame: 1 day
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: 1 day
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
citation: Hawke F, Sadler SG, Katzberg HD, Pourkazemi F, Chuter V, Burns J. Non-drug therapies for the secondary prevention of lower limb muscle cramps. Cochrane Database Syst Rev. 2021 May 17;5(5):CD008496. doi: 10.1002/14651858.CD008496.pub3.