An interventional study of Extracorporeal Shockwave Therapy (Group A) and Mesotherapy (Group B) in Myofascial Pain Syndrome and Trigger Point Pain, Myofascial, sponsored by University of Palermo. Completed at 1 site in Italy. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by University of Palermo · Not applicable, Interventional, and Treatment
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.
1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →University of Palermo is the lead sponsor of 142 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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).
Other: Extracorporeal Shockwave Therapy (Group A)
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.
Other: Mesotherapy (Group B)
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).
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.
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.
Time frame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
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.
Time frame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
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.
Time frame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
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.
Time frame: At the time of recruitment (T0). After 5 weeks from the start of treatment (T1). After 30 days from the end of treatment (T2).
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Palermo