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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-04-20 with a primary completion date of 2027-11-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Wu T Hsing, MD, PhD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT05907239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Temporomandibular Joint Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05907239 currently recruiting?
Yes, NCT05907239 is actively recruiting participants. Contact the research team at wu@fm.usp.br for enrollment information.
Where is the NCT05907239 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT05907239 clinical trial?
NCT05907239 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Wu T Hsing, MD, PhD at University of Sao Paulo. The trial plans to enroll 100 participants.