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

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

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

Study Overview

• Status: Recruiting
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Device: Extracorporeal shockwave therapy

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyunghoon Min, MD, PhD; Phone Number: 82-31-780-1892; Email: minkhrm@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Recruiting
      • Bundang CHA Medical Center
      • Contact: Kyunghoon Min, MD, PhD; Phone Number: 82-31-780-1892; Email: minkhrm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHA University
• Investigators: Study Director: Kyunghoon Min, MD, PhD, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: myofascial pain syndrome; ESWT
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: 2021-05-029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No