Occlusal Splint and Masticatory Muscle Injection in Myofacial Pain

Study Overview
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Brief Summary
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Myofascial pain is one of the common symptoms in patients with temporomandibular joint disorders. Occlusal splint use, trigger point injections and the combination of this two methods are primary treatment options. Patients were divided into 3 groups and this three treatment was applied. We aimed to investigate the clinical and ultrasonographic effects of the treatments. Patients in the treatment groups were reexamined at 1st and 3rd months, and their clinic and ultrasonographic records were repeated. 16 healthy volunteers were also included in the study. No treatment was applied, only clinical and ultrasonographic records were taken once.

Detailed Description
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48 patients who had myofacial pain and were diagnosed with according to Diagnostic Criteria for Temporomandibular Disorders were included in the study. There were 16 patients in each group. Group 1 was treated with occlusal splint, Group 2 was treated with occlusal splint and masseter muscle lidocaine injection, Group 3 was treated with masseter muscle lidocaine injection and Group 4 consisted of healthy volunteers. Visual analogue scale used for pain evaluation. Also, maximum mouth opening, lateral and protrusion movements of all groups were measured before any treatment. Masseter muscle volume was evaluated by ultrasonography whereas masseter muscle elasticity was evaluated by elastography before the masseter muscle lidocaine injection and occlusal splint treatment. In Group 2 and Group 3, masseter muscle injections were repeated two more times, on 7th and 14th days. Clinical and ultrasonographic measurements were repeated at 1st and 3rd months.

Official Title
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Evaluation of the Effects of Occlusal Splint and Intramuscular Injection in Patients With Myofascial Pain

Conditions
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Myofacial Pain

Intervention / Treatment
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* Device: Occlusal splint treatment
* Procedure: Masticatory muscle injection
* Combination Product: Combination of occlusal splint and masticatory muscle injection treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication of muscle pain according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree, Having minimum three trigger points in the masseter muscles on palpation (active or latent), No medical or surgical treatment for temporomandibular joint in the last 3 months, No history of occlusal splint treatment, Not had a masticatory muscle injection or dry needling before, Absence of active caries and pulpal lesions, No missing teeth other than the third molar, Exclusion Criteria: Intra-Articular Disorders or Degenerative Joint Disease indication according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic decision tree, Presence of active infection in the masseter trigger point area, Being in the mixed dentition period, The patient has used an occlusal splint before, Known allergy to local anesthetics, Having a needle phobia, Presence of congenital head and neck deformity, Having systemic joint disease, Presence of cardiovascular disease, thyroid disease, diabetes, hypertension, renal failure, isolated muscle disease, rheumatological and neurological disease, Having a history of trauma in the head and neck region in the last 2 years, Presence of malignancy or having undergone head and neck radiotherapy/chemotherapy in the last 2 years, Presence of bleeding disorder, Use of analgesic, corticosteroid and anticonvulsant drugs, Presence of fibromyalgia diagnosis, Being treated by a neurologist for neurological disorders and/or neuropathic pain and/or headache, Pregnancy or lactation, Having a known psychiatric disorder and using antidepressants in the last 6 months, Having drug and/or alcohol addiction, Being under active orthodontic treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: A prospective randomized controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Occlusal Splint Group<br>Only occlusal splint was made for this patients. | Device: Occlusal splint treatment<br>* Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.<br>|
| Active Comparator: Masticatory muscle injection group<br>Only intramuscular injection was applied to this patients. Intramuscular injectable form of Lidocaine Hydrochloride (20mg/ml, Jetokain Simplex, ADEKA, Samsun, Turkey) was injected. 0,3 ml was injected to all trigger points. | Procedure: Masticatory muscle injection<br>* Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.<br>|
| Active Comparator: Occlusal splint and masticatory muscle injection combination group<br>Intramuscular injectable form of Lidocaine Hydrochloride (20mg/ml, Jetokain Simplex, ADEKA, Samsun, Turkey) was injected. 0,3 ml was injected to all trigger points. Patients were started to use their occlusal splints in the evening of the injection day. | Combination Product: Combination of occlusal splint and masticatory muscle injection treatments<br>* Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Occlusal splint was also made and they started to use the day which first injection was made. And continue to use the occlusal splint for 3 months. Injection was repeated 3 times, once a week.<br>|
| No Intervention: Control group<br>16 healthy volunteers was involved. Not given any treatment to these volunteers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the elasticity of masseter muscle | masseter muscle elasticity was evaluated by shear-wave sonoelastography | Before the treatment (day 0), in the 1st and 3rd months of the treatment | 
| The change of the pain score | Severity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain) | Before the treatment (day 0), in the 1st and 3rd months of the treatment | 
| The change of the maximum mouth opening | maximum mouth opening was measured by the reference of right upper and lower central incisors. | Before the treatment (day 0), in the 1st and 3rd months of the treatment | 
| The change of the volume of masseter muscle | masseter muscle volume was measured by ultrasonography | Before the treatment (day 0), in the 1st and 3rd months of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofacial Pain, Trigger point injection, Occlusal splint, Ultrasonography, Elastography