Temporomandibular Joint DisordersNCT05907239
Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin
A study testing Focused Extracorporeal Shockwave Therapy in people with Temporomandibular Joint Disorders and Extracorporeal Shockwave Therapy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Extracorporeal Shockwave Therapy
- What is being tested?
- Focused Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2023to 25 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leandro R Iuamoto, MD contact
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo General Hospital
São Paulo, São Paulo, 05403-010
Wu T Hsing, MD, PhD, +5511981998157, wu@fm.usp.br
Leandro R Iuamoto, MD, leandro.iuamoto@fm.usp.br
About this study
Official title: 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:
- Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment;
- Degree of inflammation, using ultrasound evaluation in the temporomandibular joint relating to the degree of pain after focal shockwave therapy for 5 weeks;
- 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;
- 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;
- 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.
Read the 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
- Being tested
- Focused Extracorporeal Shockwave Therapy, Placebo Focused Extracorporeal Shockwave Therapy
- Keywords
- Temporomandibular Joint Disorders, Extracorporeal Shockwave Therapy, Temporomandibular Joint Dysfunction Syndrome, High-Energy Shock Waves, Pain Management
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Extracorporeal Shockwave TherapyDevice
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 Focused Extracorporeal Shockwave TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Placebo Focused Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Scale ("VAS")
Change of pain perception after application of focal shock wave therapy ranging from 0 (painless) to 10 (painful)
Measured: 3 months
Secondary outcomes (4)
Pressure pain threshold
Test that uses an algometer in order to define the minimum pressure that triggers pain, at pre-established points (temporomandibular region).
Measured: 3 months
Range of Motion
Change of range of motion (ROM) of the temporomandibular joint using ruler
Measured: 3 months
Quality of life assessed by the "Short Form Health 36" questionnaire (SF-36)
Quality of life will be assessed by the "Short Form Health 36" questionnaire (SF-36) ranging from 0 to 100
Measured: 3 months
Mandibular movement and joint noise
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start20 Apr 2023
- Primary completion3 Nov 2027 (estimated)
- Study completion25 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Tu Hsing, University of Sao Paulo General Hospital
- Investigators
- Wu T Hsing, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907239
- Sponsor's protocol ID
- 64637022.5.0000.0068
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only Study Protocol will be shared and other details of the study (Statistical analysis plan, clinical study report) at the end of recruiting phase.
Publications
Asquini G, Pitance L, Michelotti A, Falla D. Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review. J Oral Rehabil. 2022 Apr;49(4):442-455. doi: 10.1111/joor.13299. Epub 2022 Jan 17.
PubMed 34931336Chung J, Lobbezoo F, van Selms MKA, Chattrattrai T, Aarab G, Mitrirattanakul S. Physical, psychological and socio-demographic predictors related to patients' self-belief of their temporomandibular disorders' aetiology. J Oral Rehabil. 2021 Feb;48(2):109-123. doi: 10.1111/joor.13113. Epub 2020 Oct 26.
PubMed 33051894Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Lipton JA, Ship JA, Larach-Robinson D. Estimated prevalence and distribution of reported orofacial pain in the United States. J Am Dent Assoc. 1993 Oct;124(10):115-21. doi: 10.14219/jada.archive.1993.0200. No abstract available.
PubMed 8409001Skarmeta NP, Pesce MC, Saldivia J, Espinoza-Mellado P, Montini F, Sotomayor C. Changes in understanding of painful temporomandibular disorders: the history of a transformation. Quintessence Int. 2019;50(8):662-669. doi: 10.3290/j.qi.a42779.
PubMed 31286120Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.
PubMed 16813476Shimada A, Ishigaki S, Matsuka Y, Komiyama O, Torisu T, Oono Y, Sato H, Naganawa T, Mine A, Yamazaki Y, Okura K, Sakuma Y, Sasaki K. Effects of exercise therapy on painful temporomandibular disorders. J Oral Rehabil. 2019 May;46(5):475-481. doi: 10.1111/joor.12770. Epub 2019 Feb 19.
PubMed 30664815Arber W, Kuhnlein U. [Mutational loss of the B-specific restriction in bacteriophage fd]. Pathol Microbiol (Basel). 1967;30(6):946-52. No abstract available. German.
PubMed 4873409Vervaeke K, Verhelst PJ, Orhan K, Lund B, Benchimol D, Van der Cruyssen F, De Laat A, Jacobs R, Politis C. Correlation of MRI and arthroscopic findings with clinical outcome in temporomandibular joint disorders: a retrospective cohort study. Head Face Med. 2022 Jan 7;18(1):2. doi: 10.1186/s13005-021-00305-y.
PubMed 34996509Li W, Wu J. Treatment of Temporomandibular Joint Disorders by Ultrashort Wave and Extracorporeal Shock Wave: A Comparative Study. Med Sci Monit. 2020 Jun 21;26:e923461. doi: 10.12659/MSM.923461.
PubMed 32564051Jiao K, Niu LN, Wang MQ, Dai J, Yu SB, Liu XD, Wang J. Subchondral bone loss following orthodontically induced cartilage degradation in the mandibular condyles of rats. Bone. 2011 Feb;48(2):362-71. doi: 10.1016/j.bone.2010.09.010. Epub 2010 Sep 17.
PubMed 20850574Ioppolo F, Rompe JD, Furia JP, Cacchio A. Clinical application of shock wave therapy (SWT) in musculoskeletal disorders. Eur J Phys Rehabil Med. 2014 Apr;50(2):217-30. Epub 2014 Mar 26.
PubMed 24667365Imamura M, Alamino S, Hsing WT, Alfieri FM, Schmitz C, Battistella LR. Radial extracorporeal shock wave therapy for disabling pain due to severe primary knee osteoarthritis. J Rehabil Med. 2017 Jan 19;49(1):54-62. doi: 10.2340/16501977-2148.
PubMed 27904912Iuamoto LR, Imamura M, Sameshima K, Meyer A, Simis M, Battistella LR, Fregni F. Functional Changes in Cortical Activity of Patients Submitted to Knee Osteoarthritis Treatment: An Exploratory Pilot Study. Am J Phys Med Rehabil. 2022 Oct 1;101(10):920-930. doi: 10.1097/PHM.0000000000001931. Epub 2021 Nov 18.
PubMed 34799508Santamato A, Beatrice R, Micello MF, Fortunato F, Panza F, Bristogiannis C, Cleopazzo E, Macarini L, Picelli A, Baricich A, Ranieri M. Power Doppler Ultrasound Findings before and after Focused Extracorporeal Shock Wave Therapy for Achilles Tendinopathy: A Pilot Study on Pain Reduction and Neovascularization Effect. Ultrasound Med Biol. 2019 May;45(5):1316-1323. doi: 10.1016/j.ultrasmedbio.2018.12.009. Epub 2019 Feb 8.
PubMed 30739723
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Focal Extracorporeal Shock Wave Therapy in the Treatment of Temporomandibular Disorders of Muscular Origin: a Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05907239
- Acronym / sponsor ID
- 64637022.5.0000.0068
- Keywords
- Temporomandibular Joint Disorders, Extracorporeal Shockwave Therapy, Temporomandibular Joint Dysfunction Syndrome, High-Energy Shock Waves, Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 3 Nov 2027 (estimated)
- Study completion
- 25 Jun 2029 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment;
- Degree of inflammation, using ultrasound evaluation in the temporomandibular joint relating to the degree of pain after focal shockwave therapy for 5 weeks;
- 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;
- 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;
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Focused Extracorporeal Shockwave TherapyTreatment 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 |
| Placebo | Placebo comparator | Device: Placebo Focused Extracorporeal Shockwave TherapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Extracorporeal Shockwave TherapyWe 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. | Device | Treatment group |
| Placebo Focused Extracorporeal Shockwave TherapyWe 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. | Device | Placebo |
Primary outcome
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)
4 secondary outcomes
Pressure pain threshold
Time frame: 3 months
Range of Motion
Time frame: 3 months
Quality of life assessed by the "Short Form Health 36" questionnaire (SF-36)
Time frame: 3 months
Mandibular movement and joint noise
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 34931336Asquini G, Pitance L, Michelotti A, Falla D. Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review. J Oral Rehabil. 2022 Apr;49(4):442-455. doi: 10.1111/joor.13299. Epub 2022 Jan 17.
- Background: PubMed 33051894Chung J, Lobbezoo F, van Selms MKA, Chattrattrai T, Aarab G, Mitrirattanakul S. Physical, psychological and socio-demographic predictors related to patients' self-belief of their temporomandibular disorders' aetiology. J Oral Rehabil. 2021 Feb;48(2):109-123. doi: 10.1111/joor.13113. Epub 2020 Oct 26.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 8409001Lipton JA, Ship JA, Larach-Robinson D. Estimated prevalence and distribution of reported orofacial pain in the United States. J Am Dent Assoc. 1993 Oct;124(10):115-21. doi: 10.14219/jada.archive.1993.0200. No abstract available.
- Background: PubMed 31286120Skarmeta NP, Pesce MC, Saldivia J, Espinoza-Mellado P, Montini F, Sotomayor C. Changes in understanding of painful temporomandibular disorders: the history of a transformation. Quintessence Int. 2019;50(8):662-669. doi: 10.3290/j.qi.a42779.
- Background: PubMed 16813476Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73.
- Background: PubMed 30664815Shimada A, Ishigaki S, Matsuka Y, Komiyama O, Torisu T, Oono Y, Sato H, Naganawa T, Mine A, Yamazaki Y, Okura K, Sakuma Y, Sasaki K. Effects of exercise therapy on painful temporomandibular disorders. J Oral Rehabil. 2019 May;46(5):475-481. doi: 10.1111/joor.12770. Epub 2019 Feb 19.
- Background: PubMed 4873409Arber W, Kuhnlein U. [Mutational loss of the B-specific restriction in bacteriophage fd]. Pathol Microbiol (Basel). 1967;30(6):946-52. No abstract available. German.
- Background: PubMed 34996509Vervaeke K, Verhelst PJ, Orhan K, Lund B, Benchimol D, Van der Cruyssen F, De Laat A, Jacobs R, Politis C. Correlation of MRI and arthroscopic findings with clinical outcome in temporomandibular joint disorders: a retrospective cohort study. Head Face Med. 2022 Jan 7;18(1):2. doi: 10.1186/s13005-021-00305-y.
- Background: PubMed 32564051Li W, Wu J. Treatment of Temporomandibular Joint Disorders by Ultrashort Wave and Extracorporeal Shock Wave: A Comparative Study. Med Sci Monit. 2020 Jun 21;26:e923461. doi: 10.12659/MSM.923461.
- Background: PubMed 20850574Jiao K, Niu LN, Wang MQ, Dai J, Yu SB, Liu XD, Wang J. Subchondral bone loss following orthodontically induced cartilage degradation in the mandibular condyles of rats. Bone. 2011 Feb;48(2):362-71. doi: 10.1016/j.bone.2010.09.010. Epub 2010 Sep 17.
- Background: PubMed 24667365Ioppolo F, Rompe JD, Furia JP, Cacchio A. Clinical application of shock wave therapy (SWT) in musculoskeletal disorders. Eur J Phys Rehabil Med. 2014 Apr;50(2):217-30. Epub 2014 Mar 26.
- WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects.Link provided by the sponsor.
- Research diagnostic criteria for temporomandibular disorders (RDC/TMD) - PortugueseLink provided by the sponsor.
- Diagnostic Criteria for temporomandibular disorders (DC/TMD) - PortugueseLink provided by the sponsor.
- Temporomandibular Syndrome - BookLink provided by the sponsor.
- Individual participant dataSharing planned: No. Only Study Protocol will be shared and other details of the study (Statistical analysis plan, clinical study report) at the end of recruiting phase.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leandro R Iuamoto, MD contact
Wu T Hsing, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Extracorporeal Shockwave Therapy in people with Temporomandibular Joint Disorders and Extracorporeal Shockwave Therapy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wu T Hsing, MD, PhD (+5511981998157, wu@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analogue Scale ("VAS") (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907239, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.