Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorder… (NCT05907239) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin
Brazil100 participantsStarted 2023-04-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.