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.
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;
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;
Parallel
Focused Extracorporeal Shockwave Therapy
DeviceWe will apply 2000 focal shock wave impulses starting in each region of the affected masticatory muscles and looking for compromised muscles in the masticatory muscles such as: masseter, temporal, pterygoid (medial and lateral and digastric through a piezoelectric generator F7, G3 with a focus of 1.5cm in depth, frequency of 8Hz and intensity of 0.048mJ/mm² as long as it is tolerable to the patient (it can be reduced to a tolerable intensity of at least 0.018mJ/mm²) starting with a density of energy flow between 0.12 to 0.15 mJ/mm2, starting from an adaptation dose of 0.10 mJ/mm2 in the first 500 impulses. The non-stationary technique will be used, slowly moving the applicator. Shockwave therapy will be weekly, totaling five consecutive weeks.
Placebo Focused Extracorporeal Shockwave Therapy
DeviceWe will apply 2000 focal shock wave impulses starting in each region of the affected masticatory muscles and looking for compromised muscles in the masticatory muscles such as: masseter, temporal, pterygoid (medial and lateral and digastric through a piezoelectric generator F7, G3 with a focus of 0cm depth, frequency of 8Hz and intensity of 0.048mJ/mm² with a fake gel pad applicator.
Pain Visual Analogue Scale ("VAS")
Change of pain perception after application of focal shock wave therapy ranging from 0 (painless) to 10 (painful)
Pressure pain threshold
Test that uses an algometer in order to define the minimum pressure that triggers pain, at pre-established points (temporomandibular region).
Range of Motion
Change of range of motion (ROM) of the temporomandibular joint using ruler
Quality of life assessed by the "Short Form Health 36" questionnaire (SF-36)
Quality of life will be assessed by the "Short Form Health 36" questionnaire (SF-36) ranging from 0 to 100
Mandibular movement and joint noise
Mandibular movement (MM) and joint noise (JN) will be assessed by a trained physiotherapist. The opening pattern will be evaluated through the vertical extension of mandibular movement; maximum opening without assistance; maximum opening with assistance; "overbit". Mandibular movements will be evaluated for right and left lateral excursion, in addition to referred pain in movement. Protrusions and deviations from the midline will also be evaluated.
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