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

March 20, 2026 updated by: Wu Tu Hsing, University of Sao Paulo General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wu T Hsing, MD, PhD
  • Phone Number: +5511981998157
  • Email: wu@fm.usp.br

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-010
        • Recruiting
        • University of Sao Paulo General Hospital
        • Contact:
          • Wu T Hsing, MD, PhD
          • Phone Number: +5511981998157
          • Email: wu@fm.usp.br
        • Contact:
        • Principal Investigator:
          • Wu T Hsing, MD,PhD
        • Sub-Investigator:
          • Leandro R Iuamoto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Treatment group will undergo treatment with focal shock wave therapy for 5 weeks, with weekly sessions and guidance by a trained physiotherapist on habits, stretching and exercises for adequate strengthening and ergonomic guidelines to promote a better quality of life
Device: 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 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.
Placebo Comparator: Placebo
Patients in the placebo group will undergo treatment with placebo focal shockwave therapy (using a dummy applicator) for 5 weeks and guidance by a trained physiotherapist on habits, stretching and exercises for adequate strengthening and ergonomic guidelines to promote a better quality of life
Device: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Visual Analogue Scale ("VAS")
Time Frame: 3 months
Change of pain perception after application of focal shock wave therapy ranging from 0 (painless) to 10 (painful)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: 3 months
Test that uses an algometer in order to define the minimum pressure that triggers pain, at pre-established points (temporomandibular region).
3 months
Mandibular movement and joint noise
Time Frame: 3 months
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
Range of Motion
Time Frame: 3 months
Change of range of motion (ROM) of the temporomandibular joint using ruler
3 months
Quality of life assessed by the "Short Form Health 36" questionnaire (SF-36)
Time Frame: 3 months
Quality of life will be assessed by the "Short Form Health 36" questionnaire (SF-36) ranging from 0 to 100
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Wu T Hsing, MD, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Estimated)

November 3, 2027

Study Completion (Estimated)

June 25, 2029

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64637022.5.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only Study Protocol will be shared and other details of the study (Statistical analysis plan, clinical study report) at the end of recruiting phase.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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