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

Primary Purpose

Myofascial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shockwave therapy
Sponsored by
CHA University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring ESWT, myofascial pain syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bundang CHA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A (4Hz)

B (8Hz)

Arm Description

ESWT frequency 4Hz washout period: 1 week

ESWT frequency 8Hz washout period: 1 week

Outcomes

Primary Outcome Measures

Change from baseline NRS (numerical rating scale) at each time frame
Pain intensity (0-10, ordinal scale)

Secondary Outcome Measures

Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame
Common Terminology Criteria for Adverse Events

Full Information

First Posted
July 9, 2021
Last Updated
August 3, 2021
Sponsor
CHA University
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1. Study Identification

Unique Protocol Identification Number
NCT04998630
Brief Title
Comparison of Focused ESWT by Frequency for Patients With Myofascial Pain Syndrome
Official Title
Comparison of Focused ESWT by Low and High Frequency for Patients With Myofascial Pain Syndrome: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHA University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
ESWT, myofascial pain syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (4Hz)
Arm Type
Experimental
Arm Description
ESWT frequency 4Hz washout period: 1 week
Arm Title
B (8Hz)
Arm Type
Experimental
Arm Description
ESWT frequency 8Hz washout period: 1 week
Intervention Type
Device
Intervention Name(s)
Extracorporeal shockwave therapy
Intervention Description
Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08~0.28 mJ/m2) the degree to which the subject can tolerate
Primary Outcome Measure Information:
Title
Change from baseline NRS (numerical rating scale) at each time frame
Description
Pain intensity (0-10, ordinal scale)
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
Secondary Outcome Measure Information:
Title
Number of treatment-related adverse events as assessed by CTCAE v4.0 at each time frame
Description
Common Terminology Criteria for Adverse Events
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those diagnosed with myofascial pain syndrome according to Simon's criteria Pain is 4 points or more on the Numerical Rating Scale (NRS) Exclusion Criteria: Pain is due to trauma, fibromyalgia and neurological disorders including neuromyopathy, myelopathy, and stroke 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 If there is a high risk of bleeding due to severe coagulopathy, etc. or if you have recently had severe bleeding (except taking antiplatelet) If you have a tumor, infection, kidney failure, severe liver disease, epilepsy, skin disease, or mental retardation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyunghoon Min, MD, PhD
Phone
82-31-780-1892
Email
minkhrm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyunghoon Min, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Bundang CHA Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyunghoon Min, MD, PhD
Phone
82-31-780-1892
Email
minkhrm@gmail.com

12. IPD Sharing Statement

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

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