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

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ClinicalTrials.gov Identifier: NCT04998630
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
CHA University

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

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome Device: Extracorporeal shockwave therapy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Focused ESWT by Low and High Frequency for Patients With Myofascial Pain Syndrome: a Pilot Study
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: A (4Hz)
ESWT frequency 4Hz washout period: 1 week
 Device: Extracorporeal shockwave therapy
Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08~0.28 mJ/m2) the degree to which the subject can tolerate
Experimental: B (8Hz)
ESWT frequency 8Hz washout period: 1 week
 Device: Extracorporeal shockwave therapy
Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08~0.28 mJ/m2) the degree to which the subject can tolerate


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline NRS (numerical rating scale) at each time frame [ Time Frame: 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 ]
    Pain intensity (0-10, ordinal scale)


Secondary Outcome Measures :
  1. Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame [ Time Frame: 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 ]
    Common Terminology Criteria for Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Those diagnosed with myofascial pain syndrome according to Simon's criteria
  2. Pain is 4 points or more on the Numerical Rating Scale (NRS)

Exclusion Criteria:

  1. Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke
  2. 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
  3. If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet)
  4. If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04998630


Contacts
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Contact: Kyunghoon Min, MD, PhD 82-31-780-1892 minkhrm@gmail.com

Locations
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Korea, Republic of
Bundang CHA Medical Center Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Contact: Kyunghoon Min, MD, PhD    82-31-780-1892    minkhrm@gmail.com   
Sponsors and Collaborators
CHA University
Investigators
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Study Director: Kyunghoon Min, MD, PhD Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
More Information
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Responsible Party: CHA University
ClinicalTrials.gov Identifier: NCT04998630    
Other Study ID Numbers: 2021-05-029
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHA University:
ESWT
myofascial pain syndrome
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
 Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases