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New treatment option for Temporomandibular Joint Disorders
Official title Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin
ClinicalTrials.gov ID: NCT05907239
What this study is testing
- What it's testing
- 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.
- Time commitment: about 1 week
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 week per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.