Clinical trial NCT01187316: Treatment of Temporomandibular Disorders
Official title: Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Facial Pain
Temporomandibular Joint Disorders
Transcutaneous Electric Nerve Stimulation
Adolescent
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 8
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain
timeFrame: Two times a week
Secondary outcomes:
measure: Maximum mouth opening amplitude
timeFrame: Two times a week
Other outcomes:
Locations:
city: Camaragibe
country: Brazil
facility: Faculty of Dentistry of Pernambuco; Orofacial Control Center
state: Pernambuco
city: Recife
country: Brazil
facility: Faculty of Dentistry of Pernambuco; Orofacial Control Center
state: Pernambuco
Study officials:
affiliation: University of Pernambuco
name: Arnaldo F Caldas Junior, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Bahia
name: Silvia D Benevides, Ms
role: STUDY_DIRECTOR
affiliation: University of Pernambuco
name: Mauricio Kosminsky, PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
citation: 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.
citation: Nilsson IM. Reliability, validity, incidence and impact of temporormandibular pain disorders in adolescents. Swed Dent J Suppl. 2007;(183):7-86.