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

Not Applicable

Completed

• Conditions: Trigger Point Pain, Myofascial; Myofascial Pain Syndrome

• Registration Number: NCT06246591
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone; 🇮🇹 Palermo, Italy