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

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06246591
• Other study ID #: MFR012024
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome
• Trigger Point Pain, Myofascial

Intervention

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).
• 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.

Locations

Country	Name	City	State
Italy	Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).