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

NCT05907239 | Recruiting

• 1 other identifier: 64637022.5.0000.0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment;
2. 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. 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. 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. 5.Pain control medication will also be considered and compared before and after the proposed treatment for 5 weeks.

Conditions

Temporomandibular Joint Disorders; Extracorporeal Shockwave Therapy

Keywords

Temporomandibular Joint Disorders; Extracorporeal Shockwave Therapy; Temporomandibular Joint Dysfunction Syndrome; High-Energy Shock Waves; Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Visual Analogue Scale ("VAS")

  Change of pain perception after application of focal shock wave therapy ranging from 0 (painless) to 10 (painful)

  3 months

Secondary Outcomes (4)

• Pressure pain threshold

  3 months

• Range of Motion

  3 months

• Quality of life assessed by the "Short Form Health 36" questionnaire (SF-36)

  3 months

• Mandibular movement and joint noise

  3 months

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Focused Extracorporeal Shockwave Therapy DEVICE

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.

Treatment group

Placebo Focused Extracorporeal Shockwave Therapy DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (25)

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Related Links

• WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects.
• Temporomandibular Syndrome - Book

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Agnosia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wu T Hsing, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu T Hsing, MD, PhD

CONTACT

+5511981998157; wu@fm.usp.br

Leandro R Iuamoto, MD

CONTACT

leandro.iuamoto@fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: One of the researchers will keep the randomization codes out of the patients' sight. Other medical researchers, separately, will apply the shockwaves and the placebo in a non-blinded manner. One researcher will assess the outcome measures, and will be blinded to the allocation of patients into groups throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center of Acupuncture of Institute of Orthopaedics and Traumatology

Model Details: 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 of HCFMUSP and will be referred to the Acupuncture Center of the Institute of Orthopedics and Traumatology of 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). 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.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 18, 2023
• Study Start: April 20, 2023
• Primary Completion (Estimated): November 3, 2027
• Study Completion (Estimated): June 25, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)