Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients

Study Overview
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Brief Summary
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The aim of this study was to compare the effectiveness of myofascial pain treatment methods.

Detailed Description
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Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.

Official Title
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Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Drug: NSAID
* Device: oral appliance
* Other: dry needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pain localized in the TMJ or in the preauricular area. no other analgesic treatment in the area of head and neck during last 12 months Exclusion Criteria: inflammation in the oral cavity that emerge as a myofascial pain earlier splint therapy pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants systemic diseases e.g. rheumatic, metabolic lack of stability in the masticatory organ motor system masticatory organ injury
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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dry needling + oral appliance<br>Three visits are needed in this therapy method. Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd) Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, solution for skin disinfection, sterile gauze. Exposition time : 30 minutes once a week | Device: oral appliance<br>* The stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements.<br>Other: dry needling<br>* Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd)<br>|
| Experimental: antiinflammatory drugs + splint therapy<br>Patient's instruction for NSAID use: Nimesulide 2*100 mg/ 24 h- twice a day one pill of the 100 mg Nimesulide during 14 days | Drug: NSAID<br>* Nimesulide has anti-inflammatory and analgesic properties. Like other NSAIDs it inhibits the action of COX . If prostaglandins can not be further synthesized, so there is no factor able to excite local nociceptors. According to t must be taken regularly for a minimum 2 weeks to achieve appropriate blood concentration.<br>* Other names: nimesulid;Device: oral appliance<br>* The stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements.<br>|
| Active Comparator: splint therapy<br>Splint therapy is an useful treatment method for several group of patients e.g TMD patients, patients with retrodiscitis, patients with muscle pain disorders like local muscle soreness or chronic myalgia. The patients have been instructed to use the appliance during nighttime. After 7 days the patient had to came back for a control visit. | Device: oral appliance<br>* The stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | It is a continuous scale comprised of a horizontal line, usually 10 cm in length. no pain (score of 0) and pain as bad as it could be (score of 10) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry needling, occlusal splint, NSAID, nimesulide