NCT01187316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
Last Updated

August 25, 2010

Status Verified

March 1, 2007

Enrollment Period

4 months

First QC Date

August 23, 2010

Last Update Submit

August 24, 2010

Conditions

Temporomandibular Joint Disorders

Keywords

Facial PainTemporomandibular Joint DisordersTranscutaneous Electric Nerve StimulationAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Maximum mouth opening amplitude

    Two times a week

Study Arms (2)

TENS

EXPERIMENTAL
Device: Transcutaneous electrical nerve stimulation

Massage therapy and muscle stretching

ACTIVE COMPARATOR
Other: Physiotherapy

Interventions

Transcutaneous electrical nerve stimulationDEVICE

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.

TENS
PhysiotherapyOTHER

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

Massage therapy and muscle stretching

Eligibility Criteria

Age14 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pain in orofacial area for at least 3 months
  • Diagnosed at group 1 of RDC/TMD (myofascial pain with or without mouth opening limit)

You may not qualify if:

  • Drug use for treatment of pain
  • Functional limitations that would harm diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry of Pernambuco; Orofacial Control Center

Camaragibe, Pernambuco, Brazil

Location

Faculty of Dentistry of Pernambuco; Orofacial Control Center

Recife, Pernambuco, Brazil

Location

Related 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.

    PMID: 11575192BACKGROUND

  • 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.

    PMID: 15509000BACKGROUND

  • 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.

    PMID: 16089258BACKGROUND

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

    PMID: 17506471BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Interventions

Transcutaneous Electric Nerve StimulationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Arnaldo F Caldas Junior, PhD

    University of Pernambuco

    PRINCIPAL INVESTIGATOR

  • Silvia D Benevides, Ms

    Federal University of Bahia

    STUDY DIRECTOR

  • Mauricio Kosminsky, PhD

    University of Pernambuco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

April 1, 2007

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

August 25, 2010

Record last verified: 2007-03

Locations

BR(2)