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

Not Applicable

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Other: PT program; Device: oral appliance

• Registration Number: NCT01725867
• Lead Sponsor: National Taiwan University Hospital

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

Study Timeline

• Study First Submitted: 2010-05-30
• Study Start: 2010-06
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-08
• Last Update Submitted: 2012-11-08
• Study First Posted: 2012-11-14
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PT program	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
Splint group	oral appliance	custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
range of motion (ROM)	5 mins	active and passive maximal mouth opening range
muscle strength	5 mins	maximal bite force
muscle endurance	10 mins	endurance of jaw closers
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan