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

Not Applicable

• Conditions: Myofascial Pain Syndrome
• Interventions: Device: Extracorporeal shockwave therapy

• Registration Number: NCT04998630
• Lead Sponsor: CHA University

Brief Summary

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

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 Timeline

• Study Start: 2021-06-22
• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B (8Hz)	Extracorporeal shockwave therapy	ESWT frequency 8Hz washout period: 1 week
A (4Hz)	Extracorporeal shockwave therapy	ESWT frequency 4Hz washout period: 1 week

Primary Outcome Measures

Name	Time	Method
Change from baseline NRS (numerical rating scale) at each 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

Name	Time	Method
Number of treatment-related adverse events as assessed by CTCAE v4.0 at each 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

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of