Extracorporeal Shockwave Therapy vs Mesotherapy in the Treatment of Myofascial Pain Syndrome: a Case-control Study

Myofascial Pain Syndrome (MPS) is a disorder of the musculoskeletal system manifested by referred pain associated with functional limitation, muscle contractures, and possible neuralgic manifestations; this condition is characterized by the presence of "trigger points". The goal of this case-control study was to compare the effects and benefits of treatment with ESWT vs Mesotherapy in myofascial pain syndrome. The main question it aims to answer is: what is the best rehabilitation project-program between ESWT and mesotherapy for patients with myofascial syndrome? A case-control study was conducted at the U.O.C. of "Recovery and Functional Rehabilitation" A.O.U.P. "P. Giaccone" of Palermo from February 2022 to Dicember2023. Patients were randomized into 2 groups: in group "A", No. 5 sessions of focal ESWT were given weekly; in group "B", No. 5 sessions of Mesotherapy with administration of Thiocolchicoside fl 4mg/2ml and Mepivacaine fl 10mg/1ml were given weekly. Patients in group "A" and group "B" were evaluated at baseline (T0), after 5 sessions (T1) and one month after the end of treatment (T2). Researchers will compare patients treated with ESWT and patients performing mesotherapy to see if there are real differences in terms of pain reduction and improved quality of life.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome; Trigger Point Pain, Myofascial
• Intervention / Treatment: Other: Extracorporeal Shockwave Therapy (Group A); Other: Mesotherapy (Group B)

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 35-65 years
• Diagnosis of myofascial syndrome
• NRS at T0 ≥ 4
• Written informed consent

Exclusion Criteria:

• Pregnant patients
• Patients with malignancies already diagnosed or in the process of diagnostic definition
• Coagulation disorders and/or therapy with anticoagulants
• Skin lesions and/or local infections
• Contraindications and/or allergies to the active ingredients of Mesotherapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extracorporeal Shockwave Therapy (Group A); Patients of this group were invited to our department's outpatient clinics on a weekly basis, for a total of five sessions (5 weeks), lasting approximately 20 minutes each. Treatment energy and frequency were established following the recommendations and guidelines of the International Society for Medical Shockwave Treatment (ISMST).	Other: Extracorporeal Shockwave Therapy (Group A); Each patient was evaluated before treatment for trigger points; patients underwent focal ESWT (PulseWave 2 - Mectronic Medicale s.r.l.) with a specific program for muscle contractures and myofascial pain (80-100 mJ with 2250 pulses of 5-10 Hz).
Active Comparator: Mesotherapy (Group B); Patients in this group underwent mesotherapy treatment at our outpatient clinics with Thiocolchicoside fl 4mg/2ml and Mepivacaine fl 10mg/1ml, once a week, for a total of five sessions (5 weeks), lasting about 15 minutes each.	Other: Mesotherapy (Group B); Each patient was evaluated before treatment for trigger points; after disinfection with Chlorhexidine 2% and sterile gauze, Thiocolchicoside fl 4mg/2ml, and a local anesthetic, Mepivacaine fl 10mg/1ml, diluted in 0.9% NaCl saline, for a final volume of 10 ml, were inoculated mesodermally; 6 to 12 microinjections with needle 26G 0.40x4mm, were performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of pain: Numeric Rating Scale (NRS 0-10)	The NRS is a subjective scale that rates the extent of pain with a score between 0 and 10; a score of 10 corresponds to maximum pain.	At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
Intensity o f pain: Pressure pain threshold (PPT 1-4)	PPT is defined as the minimum force applied to induce pain in the patient with myofascial pain syndrome. It has a score between 0 and 4; a score of 4 indicates maximum pain.	At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomy in activities of daily living: Barthel Index (BI 0-100)	BI is a scale that assesses the patient's autonomy in ADL. A score of 100 corresponds to a normal value.	At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
Quality of life: Short Form Health Survey 36 (0-100)	SF-36 is a scale that assesses the quality of life in relation to the disease from which patients suffer. A score of 100 corresponds to an optimal value.	At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Principal Investigator: Giulia Letizia Mauro, Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Publications and helpful links

General Publications

• 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.
• Jun JH, Park GY, Chae CS, Suh DC. The Effect of Extracorporeal Shock Wave Therapy on Pain Intensity and Neck Disability for Patients With Myofascial Pain Syndrome in the Neck and Shoulder: A Meta-Analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2021 Feb 1;100(2):120-129. doi: 10.1097/PHM.0000000000001493.
• Nahomi Kuroda M, Thomaz de Aquino Nava G, Baldini Prudencio C, Affonso Paulo D, Peixouto I, Yoshi Moroshima M, de Almeida Lourenco M, Nogueira da Silva C, Mercia Pascon Barbosa A, Rodrigues Pedroni C. Effect of ischemic compressions versus extracorporeal shockwave therapy on myofascial trigger points: A protocol of a randomized controlled trial. PLoS One. 2023 Mar 30;18(3):e0283337. doi: 10.1371/journal.pone.0283337. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Trigger point; Mesotherapy; ESWT; Myofascial syndrome; Muscle contracture
• 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: MFR012024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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