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

November 8, 2012 updated by: National Taiwan University Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain status
Time Frame: 20 mins
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)
Time Frame: 5 mins
active and passive maximal mouth opening range
5 mins
muscle strength
Time Frame: 5 mins
maximal bite force
5 mins
muscle endurance
Time Frame: 10 mins
endurance of jaw closers
10 mins
muscle stiffness
Time Frame: 10 mins
stiffness of masseter taut band
10 mins
Quality of life (QoL)
Time Frame: 15 mins
quality of life measured by Short form-36 (SF-36) Taiwanese version
15 mins

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress
Time Frame: 5 mins
Chinese 14-item perceived stress scale (PSS-14)
5 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

May 30, 2010

First Submitted That Met QC Criteria

November 8, 2012

First Posted (ESTIMATE)

November 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201003038R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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