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. 2021 May 17;2021(5):CD008496. doi: 10.1002/14651858.CD008496.pub3

NCT03864770.

Study name Extracorporeal shock wave therapy treatment for nocturnal leg cramps
Methods RCT, parallel design
Participants 30 participants.
Inclusion criteria:
  1. 20 years of age and older

  2. leg cramps at least 4 times per week in the last 2 weeks that occurred in night‐time or while resting in day‐time

  3. myofascial trigger points on gastrocnemius


Exclusion criteria:
  1. Taking medication for leg cramps or other drugs that affect research and evaluation (for example, diuretics, statins, calcium channel blockers, anticonvulsants)

  2. Congenital lower limb musculoskeletal diseases

  3. Lower limb or spine surgery

  4. Uncommunicative or cognitively impaired

  5. Patients who refuse to be recruited

Interventions Experimental: extracorporeal shock wave therapy and general physical therapy 3 times per week for 2 weeks
Control: general physical therapies 3 times a week for 2 weeks
General physical therapies include thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle
Outcomes Measured after 1 and 2 weeks of intervention
Primary:
  • Frequency of nocturnal leg cramps, measured as retrospective report from participant. Number of cramps per day in the last week.


Secondary:
  • Visual analogue scale for pain. 0 = no pain; 100 = very painful. It is unclear when this will be measured

  • Pressure pain threshold

  • Range of motion of knee and ankle joint

  • Muscle tone, measured using Myotone device

  • Pittsburgh sleep quality index

Starting date 5 March 2019
Contact information LI‐Wei Chou, PhD chouliwe@gmail.com
China Medical University Hospital
Taichung, Taiwan, 999079
+886‐4‐22052121 ext 2381
Notes We contacted the authors. The study is completed and data are being analysed. Professor Chou will email Fiona Hawke the report once it has been published.

RCT: randomised controlled trial