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Completed

NCT Number: NCT02540863

Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

Objectives: The aim of this research is to compare the effectiveness of myofascial release therapy and exercise therapy on pain, quality of sleep, anxiety, trigger points, and joint sounds in individuals with temporomandibular disorders and myofascial pain-dysfunction syndrome.

Material and Methods: A single-blind randomized clinical trial will be conducted in a university research clinic. Sixty-four subjects with temporomandibular disorders and myofascial pain-dysfunction syndrome will be randomly assigned to physical therapy group (myofascial release protocol and Rocabado exercise therapy) and control group (exercise therapy). Intensity of pain, quality of life, quality of sleep, anxiety, trigger points, and joint sounds will be collected at baseline, and forty-eight hours after the intervention phase.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Stomatognathic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of myofascial pain with or without jaw opening limitation (Ia and Ib) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD).
  • A chief complaint of acute pain (duration < 6 months) in the temporomandibular joint on at least one side.
  • The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
  • Agreement to attend evening therapy sessions.

Exclusion criteria

  • Subjects with dental pain or tender muscles caused by systemic diseases.
  • Major psychological disorders.
  • A recent history of trauma in the face and neck area.
  • Subjects wearing full or partial dentures.
  • Edentulism.
  • Therapeutic co-interventions during treatment.
  • Indication for surgical treatment of temporomandibular joint.

Treatment and study plan

myofascial release protocol and Rocabado exercise therapy

Other

Exercise therapy

Other

Primary outcomes

  1. Intensity of pain (100-mm VAS)

    Time frame: Changes from baseline in intensity of pain at twelve weeks

    A 100-mm VAS was used for determining pain intensity, ranging from 0 (no pain) to 100 (very severe pain).

Secondary outcomes

  1. Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)

    Time frame: Changes from baseline in quality of sleep at twelve weeks

    PSQI was used to study the quality of sleep. It comprises 24 items where the individuals respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction. Each component is scored from 0 to 3 (0: no problems; 3: severe problems).

  2. State and trait anxiety (state anxiety questionnaire and trait - STAI)

    Time frame: Changes from baseline in state and trait anxiety at twelve weeks

    Anxiety level were determined with the 40-item State-Trait Anxiety Inventory (STAI), which measures anxiety as a stable dimension of personality (trait or tendency to anxiety) and also includes a state subscale to detect anxiety behaviors. Subjects report their feelings in general for the trait scale and how they feel at the time of questionnaire completion for the state anxiety scale. The state anxiety scale indicates the feelings or sensations of anxiety (not at all, somewhat, moderately so, very much so) at a specific moment in time. The trait anxiety scale indicates the frequency with which anxiety is experienced (almost never, sometimes, often, almost, and always).

  3. Physical parameters of active and passive mouth opening

    Time frame: Changes from baseline in active and passive mouth opening at twelve weeks

    The subjects were asked to open her/his mouth as much as possible for the measurement of active mouth opening without pain and maximal active mouth opening. Maximal passive mouth opening was measured after the application of downward pressure on the mandible by the second and third finger of the patient. The vertical overlap of the incisors was measured by a ruler (Helios-Preisser, Gammertingen, Germany) and recorded in mm for these parameters.

  4. Physical parameters of pain in temporalis muscles

    Time frame: Changes from baseline in pain in temporalis muscles at twelve weeks

    Trigger points were assessed by palpation of temporal muscle (anterior, middle, and origin).

  5. Physical parameters of lateral condyle pole and temporal tendon insertion pain

    Time frame: Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks

    The muscles, tendon, and lateral condyles were palpated to the finger portion of the examiner´s finger applying a pressure on the muscle (1 Kg) and lateral condyles (0.5 Kg) being studied for 3-6s.

  6. Physical parameters of clicking sound when opening / close palpation

    Time frame: Changes from baseline in clicking sound when opening / close palpation at twelve weeks

    Joint sounds during mouth opening and closing were assessed with the examiner's left index finger on the right joint and the right finger on pre-auricular area. The fingertip is placed anterior to the tragus of the ear. The patient is asked to slowly open as much as possible. After each closing, the subject must place the teeth in contact at a maximal intercuspal position. The patient open and close the mouth three times. Total number of sounds was recorded on both sides.

  7. Physical parameters of pain in masseter muscles

    Time frame: Changes from baseline in pain in temporalis muscles at twelve weeks

    Trigger points were assessed by palpation of masseter muscle (anterior, deep, origin).

  8. Physical parameters of pain in lateral pterygoid muscles

    Time frame: Changes from baseline in pain in lateral pterygoid muscles at twelve weeks

    Trigger points were assessed by palpation of lateral pterygoid muscle

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Effectiveness of Myofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders: a Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Sep 16, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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