Back to resultsComparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
Primary Purpose
Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PT program
oral appliance
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder focused on measuring temporomandibular joint disorder, myofascial pain, manual myofascial release, physical therapy, oral appliance
Eligibility 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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PT program
Splint group
Arm Description
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
custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
Outcomes
Primary Outcome Measures
Pain status
Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands
Secondary Outcome Measures
range of motion (ROM)
active and passive maximal mouth opening range
muscle strength
maximal bite force
muscle endurance
endurance of jaw closers
muscle stiffness
stiffness of masseter taut band
Quality of life (QoL)
quality of life measured by Short form-36 (SF-36) Taiwanese version
Full Information
NCT ID
NCT01725867
First Posted
May 30, 2010
Last Updated
November 8, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01725867
Brief Title
Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
Official Title
Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
temporomandibular joint disorder, myofascial pain, manual myofascial release, physical therapy, oral appliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PT program
Arm Type
Experimental
Arm Description
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
Arm Title
Splint group
Arm Type
Active Comparator
Arm Description
custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
Intervention Type
Other
Intervention Name(s)
PT program
Intervention Description
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
Device
Intervention Name(s)
oral appliance
Intervention Description
custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
Primary Outcome Measure Information:
Title
Pain status
Description
Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands
Time Frame
20 mins
Secondary Outcome Measure Information:
Title
range of motion (ROM)
Description
active and passive maximal mouth opening range
Time Frame
5 mins
Title
muscle strength
Description
maximal bite force
Time Frame
5 mins
Title
muscle endurance
Description
endurance of jaw closers
Time Frame
10 mins
Title
muscle stiffness
Description
stiffness of masseter taut band
Time Frame
10 mins
Title
Quality of life (QoL)
Description
quality of life measured by Short form-36 (SF-36) Taiwanese version
Time Frame
15 mins
Other Pre-specified Outcome Measures:
Title
stress
Description
Chinese 14-item perceived stress scale (PSS-14)
Time Frame
5 mins
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
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