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Completed

NCT Number: NCT01725867

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

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).

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PT program

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

Oral Appliance

Device

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

Primary outcomes

  1. Pain status

    Time frame: 20 mins

    Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands

Secondary outcomes

  1. range of motion (ROM)

    Time frame: 5 mins

    active and passive maximal mouth opening range

  2. muscle strength

    Time frame: 5 mins

    maximal bite force

  3. muscle endurance

    Time frame: 10 mins

    endurance of jaw closers

  4. muscle stiffness

    Time frame: 10 mins

    stiffness of masseter taut band

  5. Quality of life (QoL)

    Time frame: 15 mins

    quality of life measured by Short form-36 (SF-36) Taiwanese version

Other outcomes

  1. stress

    Time frame: 5 mins

    Chinese 14-item perceived stress scale (PSS-14)

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 14, 2012
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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