Treatment of Temporomandibular Disorders

Temporomandibular Joint Disorders Clinical Trial

Official title:

Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187316
• Other study ID #: 1-R6YV8
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: August 24, 2010
• Start date: April 2007
• Est. completion date: September 2007

Study information

• Verified date: March 2007
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to carry out a pilot project comparing the effectiveness of two therapeutic approaches to temporomandibular disorders (TMDs) in adolescents. Eight female individuals diagnosed based on the Research Diagnosis Criteria for TMDs (RDC/TMD-axis 1)were randomly divided into two groups: 1) Massage therapy and muscle stretching (n=4); and 2) transcutaneous electrical nerve stimulation (TENS) (n=4). Regardless the treatment, ten sessions were held for each patient and two measurements (baseline and 10th session) were performed for the assessment of symptom evolution using a visual analog scale (VAS), maximum opening of the mouth (MOM) and pressure pain threshold (PPT). Statistical analysis wiil be carefully selected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria:

• Pain in orofacial area for at least 3 months

• Diagnosed at group 1 of RDC/TMD (myofascial pain with or without mouth opening limit)

Exclusion Criteria:

• Drug use for treatment of pain

• Functional limitations that would harm diagnosis

Study Design

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Transcutaneous electrical nerve stimulation
Sensors were positioned on anterior temporal and masseter muscles bilaterally, and the stimulation was used for 20 minutes at 150 Hz and 100 µs of pulse width; intensity was adjusted individually.

Other:
• Physiotherapy
Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.

Locations

Country	Name	City	State
Brazil	Faculty of Dentistry of Pernambuco; Orofacial Control Center	Camaragibe	Pernambuco
Brazil	Faculty of Dentistry of Pernambuco; Orofacial Control Center	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

List T, Wahlund K, Larsson B. Psychosocial functioning and dental factors in adolescents with temporomandibular disorders: a case-control study. J Orofac Pain. 2001 Summer;15(3):218-27. — View Citation

Nilsson IM. Reliability, validity, incidence and impact of temporormandibular pain disorders in adolescents. Swed Dent J Suppl. 2007;(183):7-86. — View Citation

Rodrigues D, Siriani AO, Bérzin F. Effect of conventional TENS on pain and electromyographic activity of masticatory muscles in TMD patients. Braz Oral Res. 2004 Oct-Dec;18(4):290-5. — View Citation

Visscher CM, Lobbezoo F, Naeije M. Comparison of algometry and palpation in the recognition of temporomandibular disorder pain complaints. J Orofac Pain. 2004 Summer;18(3):214-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	The subjects was asked to mark the intensity of the pain on a 100mm line, which was numbered from 0 to 10, being "0" = no pain, and 10 = to the worst pain ever felt. The outcome of pain intensity was given as a number marked by the patient.	Two times a week	Yes
Secondary	Maximum mouth opening amplitude	Subjects were asked to open their mouths as much as they could and the opening amplitude was measured using a digital caliper.	Two times a week	Yes