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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05907239

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders Extracorporeal Shockwave Therapy	Device: Focused Extracorporeal Shockwave Therapy Device: Placebo Focused Extracorporeal Shockwave Therapy	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 20, 2023

Anticipated Primary Completion Date :

Apr 20, 2025

Anticipated Study Completion Date :

Jul 20, 2026

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Pain Visual Analogue Scale [3 months]
Improvement of pain after application of focal shock wave therapy

Secondary Outcome Measures

Pressure pain threshold [3 months]
Test that uses an algometer in order to define the minimum pressure that triggers pain, at pre-established points (temporomandibular region).
Range of Motion [3 months]
Improved range of motion (ROM) of the temporomandibular joint using goniometry
Quality of life assessed by the "Short Form Health 36" questionnaire (SF-36) [3 months]
Quality of life will be assessed by the "Short Form Health 36" questionnaire (SF-36)
Mandibular movement and joint noise [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pain in the temporomandibular region Myofascial pain diagnosed with or without limitation of mouth opening based on the Research Diagnostic Criteria for TMD (RDC/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:

Patient having an abnormality in blood clotting (coagulopathy), or who is taking 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