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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725867
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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).

Condition Intervention
Temporomandibular Disorder Other: PT program Device: oral appliance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Pain status [ Time Frame: 20 mins ]
    Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands


Secondary Outcome Measures:
  • range of motion (ROM) [ Time Frame: 5 mins ]
    active and passive maximal mouth opening range

  • muscle strength [ Time Frame: 5 mins ]
    maximal bite force

  • muscle endurance [ Time Frame: 10 mins ]
    endurance of jaw closers

  • muscle stiffness [ Time Frame: 10 mins ]
    stiffness of masseter taut band

  • Quality of life (QoL) [ Time Frame: 15 mins ]
    quality of life measured by Short form-36 (SF-36) Taiwanese version


Other Outcome Measures:
  • stress [ Time Frame: 5 mins ]
    Chinese 14-item perceived stress scale (PSS-14)


Enrollment: 49
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other: 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
Active Comparator: Splint group
custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
Device: oral appliance
custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education

Detailed Description:

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725867


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01725867     History of Changes
Other Study ID Numbers: 201003038R
First Submitted: May 30, 2010
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
temporomandibular joint disorder
myofascial pain
manual myofascial release
physical therapy
oral appliance

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes