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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725867

Enrollment

Registered

2012-11-14

Start date

2010-06-30

Completion date

2011-03-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder

Keywords

temporomandibular joint disorder, myofascial pain, manual myofascial release, physical therapy, oral appliance

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

Interventions

OTHERPT 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

DEVICEoral appliance

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pain status	20 mins	Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands

Secondary

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

Other

Measure	Time frame	Description
stress	5 mins	Chinese 14-item perceived stress scale (PSS-14)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026