Using shock wave therapy to treat jaw pain from muscle disorders

Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin: a Randomized, Double-blind, Controlled Clinical Trial

This study is testing if shock wave therapy can help people with jaw pain from muscle disorders feel better and improve their daily life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT05907239 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults experiencing moderate to severe myofascial pain in the temporomandibular region for at least three months.

Not a fit: Patients with coagulopathy, active infections, or those who have undergone recent surgical treatments for TMD may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a non-invasive treatment option for patients suffering from chronic jaw pain.

How similar studies have performed: Previous studies have shown positive outcomes with shock wave therapy for musculoskeletal disorders, suggesting potential for success in this application.

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.

Where this trial is running

São Paulo, São Paulo

• 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

Conditions: Temporomandibular Joint Disorders, Extracorporeal Shockwave Therapy, Temporomandibular Joint Dysfunction Syndrome, High-Energy Shock Waves, Pain Management