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

NCT ID: NCT06246591

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Myofascial Pain Syndrome; Trigger Point Pain, Myofascial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Extracorporeal Shockwave Therapy (Group A)

Intervention Type: OTHER

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).

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.

Group Type: ACTIVE_COMPARATOR

Mesotherapy (Group B)

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giulia Letizia Mauro

Role: PRINCIPAL_INVESTIGATOR

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Locations

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Palermo, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 36013480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32520797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36996078 (View on PubMed)

Other Identifiers

MFR012024

Identifier Type: -

Identifier Source: org_study_id