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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725867
• Other study ID #: 201003038R
• Status: Completed
• Phase: N/A
• First received: May 30, 2010
• Last updated: November 8, 2012
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	stress	Chinese 14-item perceived stress scale (PSS-14)	5 mins	No
Primary	Pain status	Visual analog scale (VAS) during functional activity and pressure pain threshold (PPT) of masseter taut bands	20 mins	No
Secondary	range of motion (ROM)	active and passive maximal mouth opening range	5 mins	No
Secondary	muscle strength	maximal bite force	5 mins	No
Secondary	muscle endurance	endurance of jaw closers	10 mins	No
Secondary	muscle stiffness	stiffness of masseter taut band	10 mins	No
Secondary	Quality of life (QoL)	quality of life measured by Short form-36 (SF-36) Taiwanese version	15 mins	No