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NCT Number: NCT01187316

Treatment of Temporomandibular Disorders

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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

14 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry of Pernambuco; Orofacial Control Center, Camaragibe, Pernambuco, Brazil

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical nerve stimulation

Device

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.

Physiotherapy

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 24, 2010
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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