Using shock wave therapy to treat jaw pain from muscle disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of extracorporeal shock wave therapy (ESWT) in alleviating pain associated with temporomandibular disorders (TMD) of muscular origin. The study involves a double-blind randomized controlled design with 100 participants, divided into a treatment group receiving ESWT and a control group receiving a placebo treatment. Pain levels, range of motion, inflammation, and quality of life will be assessed at multiple time points throughout the study. The goal is to determine if ESWT can significantly improve symptoms and overall function in patients suffering from TMD.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of São Paulo General Hospital
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Wu T Hsing, MD, PhD — University of Sao Paulo
• Study coordinator: Wu T Hsing, MD, PhD
• Email: wu@fm.usp.br
• Phone: +5511981998157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.