Comparing the Effect of Physical Therapy With Oral Appliance on Temporomandibular Disorder Related Myofascial Pain
1 other identifier
interventional
49
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 14, 2012
CompletedNovember 14, 2012
November 1, 2012
9 months
May 30, 2010
November 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain status
Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands
20 mins
Secondary Outcomes (5)
range of motion (ROM)
5 mins
muscle strength
5 mins
muscle endurance
10 mins
muscle stiffness
10 mins
Quality of life (QoL)
15 mins
Other Outcomes (1)
stress
5 mins
Study Arms (2)
PT program
EXPERIMENTALmanual 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
ACTIVE COMPARATORcustom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
Interventions
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
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- National Taiwan University Hospital
Study Record Dates
First Submitted
May 30, 2010
First Posted
November 14, 2012
Study Start
June 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
November 14, 2012
Record last verified: 2012-11