RecruitingNot ApplicableNCT05907239

Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin

Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin: a Randomized, Double-blind, Controlled Clinical Trial


Sponsor

University of Sao Paulo General Hospital

Enrollment

100 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing extracorporeal shock wave therapy — a treatment that uses high-energy sound waves applied to the skin — for people with jaw pain caused by temporomandibular disorder (TMD), a condition affecting the jaw muscles and joints. **You may be eligible if...** - You have jaw or facial pain that has lasted 3 months or longer - You have been diagnosed with myofascial pain (muscle-based jaw pain) with or without limited mouth opening, based on standard diagnostic criteria - Your pain is moderate to severe (score above 4 on a 10-point scale) **You may NOT be eligible if...** - You have a blood clotting disorder or take blood thinners - You have a tumor or cancer in the treatment area - You have an active infection (skin or bone) - You have epilepsy - You received corticosteroid injections in the jaw area within the past 6 weeks - You have fibromyalgia, widespread pain, or inflammatory joint disease - You have had prior jaw surgery that affects chewing - You have depression or other mental health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFocused Extracorporeal Shockwave Therapy

We 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.

DEVICEPlacebo Focused Extracorporeal Shockwave Therapy

We 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.


Locations(1)

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

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NCT05907239


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