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Treatment of Temporomandibular Disorders

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Physiotherapy
Sponsored by
University of Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Facial Pain, Temporomandibular Joint Disorders, Transcutaneous Electric Nerve Stimulation, Adolescent

Eligibility Criteria

14 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry of Pernambuco; Orofacial Control Center
  • Faculty of Dentistry of Pernambuco; Orofacial Control Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TENS

Massage therapy and muscle stretching

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 23, 2010
Last Updated
August 24, 2010
Sponsor
University of Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01187316
Brief Title
Treatment of Temporomandibular Disorders
Official Title
Massage and Transcutaneous Electrical Nerve Stimulation Therapies for Temporomandibular Disorders in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pernambuco

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Facial Pain, Temporomandibular Joint Disorders, Transcutaneous Electric Nerve Stimulation, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS
Arm Type
Experimental
Arm Title
Massage therapy and muscle stretching
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
Two times a week
Secondary Outcome Measure Information:
Title
Maximum mouth opening amplitude
Description
Subjects were asked to open their mouths as much as they could and the opening amplitude was measured using a digital caliper.
Time Frame
Two times a week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaldo F Caldas Junior, PhD
Organizational Affiliation
University of Pernambuco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia D Benevides, Ms
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mauricio Kosminsky, PhD
Organizational Affiliation
University of Pernambuco
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry of Pernambuco; Orofacial Control Center
City
Camaragibe
State/Province
Pernambuco
Country
Brazil
Facility Name
Faculty of Dentistry of Pernambuco; Orofacial Control Center
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
11575192
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.
Results Reference
background
PubMed Identifier
15509000
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.
Results Reference
background
PubMed Identifier
16089258
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.
Results Reference
background
PubMed Identifier
17506471
Citation
Nilsson IM. Reliability, validity, incidence and impact of temporormandibular pain disorders in adolescents. Swed Dent J Suppl. 2007;(183):7-86.
Results Reference
background

Learn more about this trial

Treatment of Temporomandibular Disorders

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