Clinical trial NCT06246591: Extracorporeal Shockwave Therapy vs Mesotherapy in the Treatment of Myofascial Pain Syndrome: a Case-control Study
Official title: Extracorporeal Shockwave Therapy vs Mesotherapy in the Treatment of Myofascial Pain Syndrome: a Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Trigger Point Pain, Myofascial
Keywords: Muscle contracture
ESWT
Mesotherapy
Myofascial syndrome
Trigger point
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 54
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Extent of pain: Numeric Rating Scale (NRS 0-10)
timeFrame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
measure: Intensity o f pain: Pressure pain threshold (PPT 1-4)
timeFrame: 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 outcomes:
measure: Autonomy in activities of daily living: Barthel Index (BI 0-100)
timeFrame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
measure: Quality of life: Short Form Health Survey 36 (0-100)
timeFrame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Study officials:
affiliation: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
name: Giulia Letizia Mauro
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.