Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Introduction: Temporomandibular disorders (TMDs) are clinical conditions that affect the masticatory muscles, the temporomandibular joint (TMJ) and associated structures. Focal extracorporeal shock wave therapy (ESWT) can be used for the treatment of musculoskeletal disorders with good results in the literature and with the potential to treat muscular TMDs. Objective: The aim of the study is to perform a double-blind randomized controlled clinical trial to evaluate the effects of focal shock wave therapy in the treatment of pain due to temporomandibular disorders of muscular origin in adults after 5 weeks of treatment, 1 and 3 months after the end of treatment. Methods: A double-blind randomized controlled clinical trial will be carried out with 50 patients in the control group and 50 patients in the intervention group. Patients will be prospectively selected at the Orofacial Pain Outpatient Clinic of the Division of Dentistry, Instituto Central, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (IC-HCFMUSP) and will be referred to the Acupuncture Center of the Institute of Orthopedics and Traumatology of HCFMUSP (IOT-HCFMUSP). The control group will initially undergo treatment with guidelines for muscular temporomandibular disorders and treatment by shockwave therapy with a "placebo" applicator for 5 weeks, while the intervention group will undergo the same guidelines and treatment by shockwave therapy. focal point on the masticatory muscles during 5 sessions, once a week (totaling 5 weeks). After the initial treatment period, the groups will be evaluated and compared in terms of improvement in pain and quality of life, in addition to follow-up after 1 month, 3 months and 6 months after the procedure. Expected results: After the standardized treatment period of 1 weekly session in 5 consecutive weeks (totalizing 5 sessions), it is expected that there will be an improvement in the pain Visual Analogue Scale (VAS) and in the quality of life of patients with muscular TMDs. As there is a stimulus for differentiation of mesenchymal stem cells, neovascularization and release of angiogenic factors to occur, the effect of ESWT is expected to be lasting throughout the reassessments at 1 and 3 months. Keywords: Temporomandibular Joint Disorders, Extracorporeal Shockwave Therapy, Temporomandibular Joint Dysfunction Syndrome, High-Energy Shock Waves, Pain Management ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05907239
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Wu T Hsing, MD, PhD
Phone +5511981998157
Email wu@fm.usp.br
Status Recruiting
Phase N/A
Start date April 20, 2023
Completion date July 20, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03675659 - Intra-articular Magnesium Sulfate for Tmj Dysfunction Early Phase 1
Completed NCT05740826 - Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction
Recruiting NCT05006963 - Tele-Rehabilitation in Patients With Temporomandibular Dysfunction N/A
Active, not recruiting NCT06103851 - Effect of Mask Use on Jaw Functionality
Not yet recruiting NCT02908568 - Stimulation of the Proprioceptive Trigeminocardiac Reflex Phase 2/Phase 3
Completed NCT03119324 - Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain N/A
Completed NCT02247063 - Motor Cortex as a Research & Therapeutic Target in TMD N/A
Recruiting NCT06046521 - Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures
Completed NCT00009594 - Alternative Medicine Approaches for Women With Temporomandibular Disorders Phase 2
Completed NCT00010621 - Complementary Medicine Approaches to TMD Pain Management Phase 2
Completed NCT06055855 - Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders N/A
Not yet recruiting NCT06259344 - Pain Science Education Administered in Full or Fractioned Dosage Modes for Temporomandibular Disorders N/A
Recruiting NCT06035341 - The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction N/A
Completed NCT05821985 - Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy N/A
Completed NCT06005922 - The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain N/A
Completed NCT06034756 - Temporomandibular Joint Problems and Core Stabilization
Completed NCT03576079 - Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction N/A
Completed NCT04557878 - Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction Phase 2
Completed NCT04477122 - Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome. N/A
Completed NCT00237042 - Managing Temporomandibular Disorder (TMD) Symptoms N/A