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

NCT ID: NCT04998630

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2021-12-31

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.

Conditions

Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A (4Hz)

ESWT frequency 4Hz washout period: 1 week

Group Type: EXPERIMENTAL

Extracorporeal shockwave therapy

Intervention Type: DEVICE

Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08\~0.28 mJ/m2) the degree to which the subject can tolerate

B (8Hz)

ESWT frequency 8Hz washout period: 1 week

Group Type: EXPERIMENTAL

Extracorporeal shockwave therapy

Intervention Type: DEVICE

Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08\~0.28 mJ/m2) the degree to which the subject can tolerate

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHA University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyunghoon Min, MD, PhD

Role: STUDY_DIRECTOR

Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

Locations

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kyunghoon Min, MD, PhD

Role: CONTACT

minkhrm@gmail.com

82-31-780-1892

Facility Contacts

Kyunghoon Min, MD, PhD

Role: primary

minkhrm@gmail.com

82-31-780-1892

Other Identifiers

2021-05-029

Identifier Type: -

Identifier Source: org_study_id