Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review.
Giacomo Asquini, Laurent Pitance, Ambra Michelotti...
https://pubmed.ncbi.nlm.nih.gov/34931336Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05907239
Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin: a Randomized, Double-blind, Controlled Clinical Trial
Led by University of Sao Paulo General Hospital · Updated on 2026-03-25
100
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of focal extracorporeal shock wave therapy (ESWT) on adults with temporomandibular disorders (TMD) that cause muscle pain. The study aims to evaluate pain improvement after 5 weeks of treatment and at 1 and 3 months post-treatment. Secondary goals include assessing jaw movement, joint inflammation, quality of life, and the use of pain medication. Safety will be monitored by tracking any side effects throughout the study. The study involves two groups: one receiving real focal shock wave therapy applied weekly for 5 weeks to affected jaw muscles, and the other receiving placebo treatment with a dummy applicator. Both groups will also get guidance from a physiotherapist on habits, stretching, exercises, and ergonomic practices to improve quality of life. Follow-up evaluations will occur at 1, 3, and 6 months after treatment. Participants will undergo assessments including pain measurement using a Visual Analogue Scale, range of motion testing, ultrasound evaluation of inflammation, and questionnaires on quality of life. Jaw movement, joint noise, and pressure pain threshold will be recorded during treatment sessions and follow-ups. Researchers will also compare pain medication use before and after treatment. The total participation includes 5 weeks of treatment and multiple follow-up visits over several months.
CONDITIONS
Brief 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
You may qualify if you...
- Pain in the temporomandibular region
- Myofascial pain diagnosed with or without limited mouth opening based on Diagnostic Criteria for TMD
- Myofascial pain with or without joint abnormalities
- Moderate to severe pain with Visual Analogue Scale (VAS) score greater than 4
- Duration of temporomandibular disorder pain at least 3 months
- Signed informed consent form to participate in the study
You will not qualify if you...
- Blood clotting abnormalities or use of anticoagulants
- Primary malignant disease in the treatment area
- Acute soft tissue or bone infection
- Systemic infections
- Epilepsy
- Corticosteroid injection at the treatment site within the last 6 weeks
- High risk for anesthesia or analgesia use
- Polyarthritis
- Polytrauma or local joint infections
- Previous temporomandibular surgeries affecting chewing
- Physiotherapy or acupuncture treatment within the last 3 months
- Depression or other mental disorders
- Diagnosis of fibromyalgia
- Systemic inflammatory rheumatic diseases
- Widespread or overlapping pain that predominates over TMD muscle pain
- Inability to understand the treatment protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks
Participants receive weekly focal shock wave therapy sessions or placebo sessions for 5 weeks, along with guidance on habits, stretching, exercises, and ergonomic practices to improve quality of life.
Weekly visits for 5 weeks
Follow-up
Duration - 6 months
Participants are evaluated at 1 month, 3 months, and 6 months after the end of treatment to assess pain, quality of life, and jaw function.
3 visits (at 1, 3, and 6 months post-treatment)
Trial Site Locations
Total: 1 location
1
University of São Paulo General Hospital
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
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Research Team
W
Wu T Hsing, MD, PhD
L
Leandro R Iuamoto, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Physical, psychological and socio-demographic predictors related to patients' self-belief of their temporomandibular disorders' aetiology.
Joey Chung, Frank Lobbezoo, Maurits K A van Selms...
https://pubmed.ncbi.nlm.nih.gov/33051894Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†.
Eric Schiffman, Richard Ohrbach, Edmond Truelove...
https://pubmed.ncbi.nlm.nih.gov/24482784Estimated prevalence and distribution of reported orofacial pain in the United States.
J A Lipton, J A Ship, D Larach-Robinson
https://pubmed.ncbi.nlm.nih.gov/8409001Changes in understanding of painful temporomandibular disorders: the history of a transformation.
Nicolas Patri Skármeta, Maria Cecilia Pesce, Josefina Saldivia...
https://pubmed.ncbi.nlm.nih.gov/31286120A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder.
Marega S Medlicott, Susan R Harris
https://pubmed.ncbi.nlm.nih.gov/16813476Effects of exercise therapy on painful temporomandibular disorders.
Akiko Shimada, Shoichi Ishigaki, Yoshizo Matsuka...
https://pubmed.ncbi.nlm.nih.gov/30664815[Mutational loss of the B-specific restriction in bacteriophage fd].
W Arber, U Kühnlein
https://pubmed.ncbi.nlm.nih.gov/4873409Correlation of MRI and arthroscopic findings with clinical outcome in temporomandibular joint disorders: a retrospective cohort study.
Kobbe Vervaeke, Pieter-Jan Verhelst, Kaan Orhan...
https://pubmed.ncbi.nlm.nih.gov/34996509Treatment of Temporomandibular Joint Disorders by Ultrashort Wave and Extracorporeal Shock Wave: A Comparative Study.
Wenyan Li, Junying Wu
https://pubmed.ncbi.nlm.nih.gov/32564051