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Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin

RecruitingNAAges 18 Years - anyAllUniversity of Sao Paulo General Hospital
NCT05907239 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of the study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in improving pain in patients with TMD pain after 5 weeks of treatment, 1 month and 3 months after the end of treatment. As secondary objectives, we plan to evaluate the effectiveness of focal shockwave therapy in relation to: 1. Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment; 2. Degree of inflammation, using ultrasound evaluation in the temporomandibular joint relating to the degree of pain after focal shockwave therapy for 5 weeks; 3. Jaw movement (MM), joint noise (RA), joint pressure (PA) and disability index (DI) will be measured at each treatment session and after 5 weeks of treatment, 1 month and 3 months after the end of treatment in the affected joints; 4. Quality of life will be assessed using the "Short Form Health 36" quest

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pain in the temporomandibular region; * Myofascial pain diagnosed with or without limitation of mouth opening based on the Diagnostic Criteria for TMD (DC/TMD); * Myofascial pain associated or not with joint abnormalities; * Presence of moderate to severe pain: Visual Analogue Scale (VAS) \>4; * Duration of TMD pain (temporomandibular musculoskeletal) ≥3 months; * Written granting of the informed consent form to participate in the study Exclusion Criteria: * Abnormality in blood clotting (coagulopathy) or using some type of anticoagulant; * Primary malignant disease (tumors) in the treatment area; * Acute infection of soft tissue or bone; * Systemic infections; * Epilepsy; * Infiltration of corticosteroids at the application site in the last 6 weeks; * Patient at high risk of some type of anesthesia or analgesia when it eventually has to be used; * Polyarthritis; * Polytrauma Local joint infections; * Previous temporomandibular surgical treatments that compromise mastication; * Treatment by physiotherapy, acupuncture before 3 months of performing the procedures * Depression or other mental disorders; * Clinical diagnosis of associated fibromyalgia; * Associated systemic inflammatory rheumatic diseases; * Widespread pain or pain elsewhere that predominates and overlaps with TMD muscle pain; * Inability to understand the treatment protocol.
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What it tests

  • Focused Extracorporeal Shockwave Therapy
  • Placebo Focused Extracorporeal Shockwave Therapy
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Where

1 site
University of São Paulo General Hospital
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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