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

NCT ID: NCT01725867

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

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

Conditions

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Temporomandibular Disorder

Keywords

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temporomandibular joint disorder myofascial pain manual myofascial release physical therapy oral appliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PT program

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

Group Type EXPERIMENTAL

PT program

Intervention Type OTHER

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

Splint group

custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education

Group Type ACTIVE_COMPARATOR

oral appliance

Intervention Type DEVICE

custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education

Interventions

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PT program

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

Intervention Type OTHER

oral appliance

custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education

Intervention Type DEVICE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

National Taiwan University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201003038R

Identifier Type: -

Identifier Source: org_study_id