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

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998630
• Other study ID #: 2021-05-029
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: CHA University
• Contact: Kyunghoon Min, MD, PhD
• Phone: 82-31-780-1892
• Email: minkhrm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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