About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Focused Extracorporeal Shockwave Therapy
- Placebo Focused Extracorporeal Shockwave Therapy