Treatment of Temporomandibular Disorders

• ClinicalTrials.gov Identifier: NCT01187316
• Recruitment Status: Completed
• First Posted: August 24, 2010
• Last Update Posted: August 25, 2010
• Sponsor: University of Pernambuco
• Information provided by: University of Pernambuco

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Joint Disorders	Device: Transcutaneous electrical nerve stimulation; Other: Physiotherapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents
• Study Start Date: April 2007
• Actual Primary Completion Date: August 2007
• Actual Study Completion Date: September 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: TENS	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.
Active Comparator: Massage therapy and muscle stretching	Other: Physiotherapy; Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: Two times a week ]
   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.

Secondary Outcome Measures :

1. Maximum mouth opening amplitude [ Time Frame: Two times a week ]
   Subjects were asked to open their mouths as much as they could and the opening amplitude was measured using a digital caliper.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Brazil

Faculty of Dentistry of Pernambuco; Orofacial Control Center

Camaragibe, Pernambuco, Brazil

Faculty of Dentistry of Pernambuco; Orofacial Control Center

Recife, Pernambuco, Brazil

Sponsors and Collaborators

University of Pernambuco

Investigators

• Principal Investigator: Arnaldo F Caldas Junior, PhD; University of Pernambuco
• Study Director: Silvia D Benevides, Ms; Federal University of Bahia
• Study Chair: Mauricio Kosminsky, PhD; University of Pernambuco

More Information

Publications:

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.

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.

Rodrigues D, Siriani AO, Berzin 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. doi: 10.1590/s1806-83242004000400003.

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

• Responsible Party: Arnaldo de França Caldas Junior, University of Pernambuco
• ClinicalTrials.gov Identifier: NCT01187316
• Other Study ID Numbers: 1-R6YV8
• First Posted: August 24, 2010
• Last Update Posted: August 25, 2010
• Last Verified: March 2007

Keywords provided by University of Pernambuco:

Facial Pain; Temporomandibular Joint Disorders; Transcutaneous Electric Nerve Stimulation; Adolescent

Additional relevant MeSH terms:

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases; Disease; Pathologic Processes; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes