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Search / Trial NCT05907239

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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jun 7, 2023

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

Temporomandibular Joint Disorders Extracorporeal Shockwave Therapy Temporomandibular Joint Dysfunction Syndrome High Energy Shock Waves Pain Management

ClinConnect Summary

This clinical trial is looking at a treatment called extracorporeal shock wave therapy (ESWT) to help people suffering from pain related to temporomandibular joint disorders (TMD), which can affect jaw movement and cause discomfort. The study aims to see if this therapy can reduce pain after 5 weeks of treatment and how effective it is in improving jaw movement, reducing inflammation, and enhancing overall quality of life during and after the treatment period.

To be eligible for the trial, participants should have moderate to severe pain in the jaw area that has lasted for at least three months. They should also be able to provide consent to join the study. Throughout the trial, participants will receive the therapy and be monitored for any side effects. Researchers will keep in touch with them, encouraging them to report any issues they might experience. This study may provide valuable information on a new way to manage TMD pain, potentially improving the lives of those affected by this condition.

Gender

ALL

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 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.

About University Of Sao Paulo General Hospital

The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.

Locations

São Paulo, Sao Paulo, Brazil

Patients applied

0 patients applied

Trial Officials

Wu T Hsing, MD, PhD

Principal Investigator

University of Sao Paulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported