Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05907239

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

Led by University of Sao Paulo General Hospital · Updated on 2026-03-25

100

Participants Needed

1

Research Sites

322 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pain in the temporomandibular region
  • Diagnosed myofascial pain with or without limited mouth opening based on Diagnostic Criteria for TMD (DC/TMD)
  • Myofascial pain with or without joint abnormalities
  • Moderate to severe pain with Visual Analogue Scale (VAS) greater than 4
  • Duration of temporomandibular musculoskeletal pain for at least 3 months
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Blood clotting disorders or use of anticoagulants
  • Primary malignant disease (tumors) in the treatment area
  • Acute infection of soft tissue or bone
  • Systemic infections
  • Epilepsy
  • Corticosteroid injection at treatment site within last 6 weeks
  • High risk for anesthesia or analgesia if needed
  • Polyarthritis
  • Polytrauma or local joint infections
  • Previous temporomandibular surgery affecting chewing
  • Physiotherapy or acupuncture treatment within 3 months before procedures
  • Depression or other mental disorders
  • Clinical diagnosis of fibromyalgia
  • Systemic inflammatory rheumatic diseases
  • Widespread or overlapping pain that predominates over TMD muscle pain
  • Unable to understand the treatment protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil, 05403-010

Actively Recruiting

Loading map...

Research Team

W

Wu T Hsing, MD, PhD

CONTACT

L

Leandro R Iuamoto, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here