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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246591
Enrollment
54
Registered
2024-02-07
Start date
2022-02-01
Completion date
2023-12-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome, Trigger Point Pain, Myofascial

Keywords

Muscle contracture, ESWT, Mesotherapy, Myofascial syndrome, Trigger point

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.

Interventions

OTHERExtracorporeal 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).

OTHERMesotherapy (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.

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Extent of pain: Numeric Rating Scale (NRS 0-10)At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).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.
Intensity o f pain: Pressure pain threshold (PPT 1-4)At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).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.

Secondary

MeasureTime frameDescription
Autonomy in activities of daily living: Barthel Index (BI 0-100)At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).BI is a scale that assesses the patient's autonomy in ADL. A score of 100 corresponds to a normal value.
Quality of life: Short Form Health Survey 36 (0-100)At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026