Extracorporeal Shock-wave Therapy in Myofascial Pain Syndrome

NCT06987721 | Completed

• 1 other identifier: AnkaraCHBilkent-E2-22-3033
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Myofascial pain syndrome (MPS) is a syndrome characterized by painful trigger points on palpation located at certain points of common muscles of the musculoskeletal system. Active trigger points may cause spontaneous pain and many other consequences that affect quality of life and loss of work force. Extracorporeal shock-wave therapy (ESWT) is a treatment method performed with the help of acoustic waves created outside the body and used in musculoskeletal problems. There are radial or focused waves that are commonly used in ESWT. In Focused ESWT (F-ESWT), the depth of the body part to be injured can be adjusted. Thus, penetration into the tissue is better than radial waves. Radial ESWT (R-ESWT), on the other hand, has a more superficial effect, and its spread in liquids with a density similar to tissues is half that of focused ESWT. It has been shown in previous studies that radial and focused ESWT waves applied to trigger points in the upper trapezius fibers reduce reflected and local pain in myofascial pain syndrome. The aim of this study is to compare the effectiveness of radial and focused ESWT types on trigger points in trapezoidal upper fibers in myofascial pain syndrome. Methods: This prospective,sham-controlled double-blind study was carried out with total of 57 patients. They were randomized into 3 groups and received R-ESWT, F-ESWT and sham protocols for 10 sessions. Patients were evaluated and compared with Numerical rating scale (NRS), Health assessment Questionnaire (HAQ) and Beck Depression Scale (BDI) before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.

Conditions

Myofacial Pain Syndrome

Keywords

Trapezius muscle; Trigger points; Pain; Therapy: pain management

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  Numerical rating scale (NRS) (0-10 scores) is used by patients to perform a self-assessment of pain intensity associated with myofascial pain syndrome. Higher scores indicates more pain related to trigger points of upper trapezius muscle fibers

  Before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.

Secondary Outcomes (2)

• Beck Depression Inventory

  Before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.

• Health Assessment Questionnaire

  Before treatment, just post treatment, 1st month, 3nd month and 6th month after treatment completed.

Study Arms (3)

Radial ESWT

Group of participants received radial ESWT.

Device: Modus ESWT-Radial

Focused ESWT

Group of participants received focused ESWT.

Device: Modus ESWT-Focused

Sham group

group of participants received sham ESWT application

Device: Modus ESWT-Sham

Interventions

Modus ESWT-Focused DEVICE

In accordance with the literature, the ESWT adjustment is made as 1500 pulses, 0.056 mj/mm, 6 Hz for focused applications. All applications were done with the same device; Modus ESWT.

Focused ESWT

Modus ESWT-Radial DEVICE

In accordance with the literature, the ESWT adjustment is made as 1500 pulses, 0.1 mj/mm, 10-16 Hz for radial applications. All applications were done with the same device; Modus ESWT.

Radial ESWT

Modus ESWT-Sham DEVICE

The sham application was made in such a way that the device was set to 0 frequency and power, making only sound. All applications were done with the same device; Modus ESWT.

Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients between 18-75 years old with myofascial pain syndrome and that have trigger points in upper trapezius muscles were participated in the study

You may qualify if:

• Patients aged between 18-70 years with myofascial pain syndrome and active trigger points in the trapezius upper fibers
• Pain related to trapezius muscle trigger points were \> 4 according to numerical rating scale (NRS)

You may not qualify if:

• Revealed any cervical disc herniation (protrusion or extrusion) that cause cervical root compression showed with magnetic resonance imaging and/or radicular pain with motor or sensory deficit
• Presence of neurological and rheumatological disorders and/or malignancy 3. Detected cognitive impairment according to mini mental test (mini mental test score \<23)
• \. Acute systemic infection or any other diseases that effect general condition 5. Participants have any open wound or sensory deficit in the application area.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, None Selected, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• Schmitz C, Csaszar NB, Milz S, Schieker M, Maffulli N, Rompe JD, Furia JP. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database. Br Med Bull. 2015;116(1):115-38. doi: 10.1093/bmb/ldv047. Epub 2015 Nov 18.

  PMID: 26585999 BACKGROUND

• Paoletta M, Moretti A, Liguori S, Toro G, Gimigliano F, Iolascon G. Efficacy and Effectiveness of Extracorporeal Shockwave Therapy in Patients with Myofascial Pain or Fibromyalgia: A Scoping Review. Medicina (Kaunas). 2022 Jul 28;58(8):1014. doi: 10.3390/medicina58081014.

  PMID: 36013480 BACKGROUND

• Urits I, Charipova K, Gress K, Schaaf AL, Gupta S, Kiernan HC, Choi PE, Jung JW, Cornett E, Kaye AD, Viswanath O. Treatment and management of myofascial pain syndrome. Best Pract Res Clin Anaesthesiol. 2020 Sep;34(3):427-448. doi: 10.1016/j.bpa.2020.08.003. Epub 2020 Aug 8.

  PMID: 33004157 BACKGROUND

• Tasoglu O, Sahin Onat S, Boluk H, Tasoglu I, Ozgirgin N. Comparision of two different dry-needling techniques in the treatment of myofascial pain syndrome. Agri. 2017 Jan;29(1):9-16. doi: 10.5505/agri.2016.38991.

  PMID: 28467572 BACKGROUND

Related Links

• Study Protocol

MeSH Terms

Conditions

Facial Neuralgia; Pain

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: May 23, 2025
• Study Start: January 18, 2022
• Primary Completion: January 25, 2024
• Study Completion: August 1, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD is going to be shared in submission process
• Access Criteria: other researchers

Locations

TU (1)