Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain

Study Overview
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Brief Summary
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the purpose of this study is to compare the effect of physical therapy (PT) program and oral appliance on patients with temporomandibular disorder (TMD)-related myofascial pain (MFP).

Detailed Description
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The details of each intervention are listed as following: physical therapy program group (PT): manual myofascial release over craniomandibular system, chin-in exercise and self-care education oral appliance group (splint): custom-made stabilization splint and self-care education

Official Title
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Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Other: PT program
* Device: oral appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) 20-65 years old female, (2) diagnosed as MFP subtype of TMD according to Research Diagnostic Criteria for TMD (RDC/TMD), (3) pain duration over 3 month, (4) palpable taut band in masseter, (5) Asymmetrical pain intensity, (6) subsided symptoms of joint inflammation. Exclusion Criteria: (1) traumatic TMD from external impact force, (2) history of traumatic cervical injury, (3) presence of systemic disease, (4) fibromyalgia, (5) co-interventions for cervical problems or TMD during study period, (6) signs of psychosomatic illness, (7) unwilling to be randomized, (8) unable to wear the splint or received intraoral myofascial release, (9)pregnancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT program<br>manual myofascial release for craniomandibular system for 30 40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks | Other: PT program<br>* manual myofascial release for craniomandibular system for 30 40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks<br>|
| Active Comparator: Splint group<br>custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education | Device: oral appliance<br>* custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain status | Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands | 20 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion (ROM) | active and passive maximal mouth opening range | 5 mins | 
| muscle strength | maximal bite force | 5 mins | 
| muscle endurance | endurance of jaw closers | 10 mins | 
| muscle stiffness | stiffness of masseter taut band | 10 mins | 
| Quality of life (QoL) | quality of life measured by Short form-36 (SF-36) Taiwanese version | 15 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular joint disorder, myofascial pain, manual myofascial release, physical therapy, oral appliance