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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2019
CompletedStudy Start
First participant enrolled
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2020
CompletedMarch 11, 2019
March 1, 2019
9 months
March 5, 2019
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency of nocturnal leg cramps (FC)
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.
1 day
Secondary Outcomes (5)
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
Study Arms (2)
Extracorporeal shock wave therapy and general physical therapy
EXPERIMENTALIn 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.
Only general physical therapy
ACTIVE COMPARATORIn 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.
Interventions
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.
The general physical therapies such as: thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle.
Eligibility Criteria
You may qualify if:
- ≥ 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)
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 999079, Taiwan
Related Publications (1)
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.
PMID: 33998664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Minister of Rehabilitation
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 6, 2019
Study Start
March 5, 2019
Primary Completion
December 5, 2019
Study Completion
February 4, 2020
Last Updated
March 11, 2019
Record last verified: 2019-03