NCT05907239 Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin
| NCT ID | NCT05907239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Temporomandibular Joint Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2027-11-03 |
Trial Parameters
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Brief Summary
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" questionnaire (SF-36) during the 5 weeks of treatment, 1 month and 3 months after the end of treatment; 5. Pain control medication will also be considered and compared before and after the proposed treatment for 5 weeks. Safety will be assessed throughout the study by monitoring the incidence of study-related adverse events. All patients will be contacted periodically and encouraged to report any side effects.
Eligibility Criteria
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