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

NCT04998630 | Unknown

• 1 other identifier: 2021-05-029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myofascial Pain Syndrome

Keywords

ESWT; myofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

A (4Hz)

EXPERIMENTAL

ESWT frequency 4Hz washout period: 1 week

Device: Extracorporeal shockwave therapy

B (8Hz)

EXPERIMENTAL

ESWT frequency 8Hz washout period: 1 week

Device: Extracorporeal shockwave therapy

Interventions

Extracorporeal shockwave therapy 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

A (4Hz); B (8Hz)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those diagnosed with myofascial pain syndrome according to Simon's criteria
• Pain is 4 points or more on the Numerical Rating Scale (NRS)

You may not qualify if:

• 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

Sponsors & Collaborators

• CHA University: lead

Study Sites (1)

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kyunghoon Min, MD, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Kyunghoon Min, MD, PhD

CONTACT

82-31-780-1892; minkhrm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 10, 2021
• Study Start: June 22, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-07

Locations

KR (1)