Temporomandibular Joint Disorders Clinical Trial
Official title:
Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin: a Randomized, Double-blind, Controlled Clinical 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 20, 2026 |
Est. primary completion date | April 20, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo General Hospital | São Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Visual Analogue Scale ("VAS") | Change of pain perception after application of focal shock wave therapy ranging from 0 (painless) to 10 (painful) | 3 months | |
Secondary | Pressure pain threshold | Test that uses an algometer in order to define the minimum pressure that triggers pain, at pre-established points (temporomandibular region). | 3 months | |
Secondary | Range of Motion | Change of range of motion (ROM) of the temporomandibular joint using ruler | 3 months | |
Secondary | 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 | 3 months | |
Secondary | 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. | 3 months |
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