Comparison of Focused ESWT by Frequency for Patients With Myofascial Pain Syndrome

Study Overview
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Brief Summary
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To investigate the efficacy and safety according to the frequency of focused ESWT in patients with myofascial pain syndrome.

Detailed Description
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Myofascial pain syndrome is one of the common causes of musculoskeletal pain seen in clinical practice and is characterized by the presence of trigger points associated with sensitive areas such as taut bands of skeletal muscle. It may also be accompanied by referred pain, which is pain in other parts of the body. Although the pathophysiology and etiology of myofascial pain syndrome and trigger points are still unknown, there are reports that myofascial pain is a complex form of neuromuscular dysfunction caused by motor and sensory abnormalities involving both the peripheral nervous system and the central nervous system. Recently, it has been considered as a method of treatment for myofascial pain syndrome. In addition, although pain reduction and functional improvement of focused ESWT in patients with myofascial pain syndrome have been reported, related studies are lacking on the effect of focused ESWT according to the frequency difference. The purpose of the study is to examine the efficacy and safety of focused type ESWT frequency in patients with myofascial pain syndrome.

Official Title
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Comparison of Focused ESWT by Low and High Frequency for Patients With Myofascial Pain Syndrome: a Pilot Study

Conditions
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Myofascial Pain Syndrome

Intervention / Treatment
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* Device: Extracorporeal shockwave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those diagnosed with myofascial pain syndrome according to Simon's criteria Pain is 4 points or more on the Numerical Rating Scale (NRS) Exclusion Criteria: Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke If you have received injection treatment for trigger points within the last 2 months or have had surgery on the painful area within 1 year If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet) If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (4Hz)<br>ESWT frequency 4Hz washout period: 1 week | Device: Extracorporeal shockwave therapy<br>* Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08 0.28 mJ/m2) the degree to which the subject can tolerate<br>|
| Experimental: B (8Hz)<br>ESWT frequency 8Hz washout period: 1 week | Device: Extracorporeal shockwave therapy<br>* Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08 0.28 mJ/m2) the degree to which the subject can tolerate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline NRS (numerical rating scale) at each time frame | Pain intensity (0-10, ordinal scale) | baseline, immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame | Common Terminology Criteria for Adverse Events | immediately after primary treatment, 1 day after primary treatment, 3 day after primary treatment, immediately after secondary treatment, 1 day after secondary treatment, 3 day after secondary treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESWT, myofascial pain syndrome