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Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
myofascial release protocol and Rocabado exercise therapy
exercise therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring myofascial pain syndrome, exercise therapy, randomized controlled trial

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    myofascial release protocol and Rocabado exercise therapy

    exercise therapy

    Arm Description

    Myofascial Release Protocol: Suboccipital release. Compression - decompression of temporomandibular joint. Horizontal release of temporomandibular joint. Deep fascia release in temporal region. Masseter deep fascia release. Pterygoiddeep fascia release. Intraoral pterygoid deep fascia release.

    Rocabado´s 6 x 6 exercises program utilizes six exercises six times by day. The patient is in supine position with a loop of 6 cm in the cervical area, and the therapist sits at the head of the bed.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)
    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).
    State and trait anxiety (state anxiety questionnaire and trait - STAI)
    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).
    Physical parameters of active and passive mouth opening
    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.
    Physical parameters of pain in temporalis muscles
    Trigger points were assessed by palpation of temporal muscle (anterior, middle, and origin).
    Physical parameters of lateral condyle pole and temporal tendon insertion pain
    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.
    Physical parameters of clicking sound when opening / close palpation
    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.
    Physical parameters of pain in masseter muscles
    Trigger points were assessed by palpation of masseter muscle (anterior, deep, origin).
    Physical parameters of pain in lateral pterygoid muscles
    Trigger points were assessed by palpation of lateral pterygoid muscle

    Full Information

    First Posted
    August 25, 2015
    Last Updated
    September 15, 2015
    Sponsor
    Universidad de Almeria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02540863
    Brief Title
    Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders
    Official Title
    Effectiveness of Myofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Almeria

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Joint Disorders
    Keywords
    myofascial pain syndrome, exercise therapy, randomized controlled trial

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    myofascial release protocol and Rocabado exercise therapy
    Arm Type
    Experimental
    Arm Description
    Myofascial Release Protocol: Suboccipital release. Compression - decompression of temporomandibular joint. Horizontal release of temporomandibular joint. Deep fascia release in temporal region. Masseter deep fascia release. Pterygoiddeep fascia release. Intraoral pterygoid deep fascia release.
    Arm Title
    exercise therapy
    Arm Type
    Active Comparator
    Arm Description
    Rocabado´s 6 x 6 exercises program utilizes six exercises six times by day. The patient is in supine position with a loop of 6 cm in the cervical area, and the therapist sits at the head of the bed.
    Intervention Type
    Other
    Intervention Name(s)
    myofascial release protocol and Rocabado exercise therapy
    Intervention Type
    Other
    Intervention Name(s)
    exercise therapy
    Primary Outcome Measure Information:
    Title
    Intensity of pain (100-mm VAS)
    Description
    A 100-mm VAS was used for determining pain intensity, ranging from 0 (no pain) to 100 (very severe pain).
    Time Frame
    Changes from baseline in intensity of pain at twelve weeks
    Secondary Outcome Measure Information:
    Title
    Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)
    Description
    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).
    Time Frame
    Changes from baseline in quality of sleep at twelve weeks
    Title
    State and trait anxiety (state anxiety questionnaire and trait - STAI)
    Description
    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).
    Time Frame
    Changes from baseline in state and trait anxiety at twelve weeks
    Title
    Physical parameters of active and passive mouth opening
    Description
    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.
    Time Frame
    Changes from baseline in active and passive mouth opening at twelve weeks
    Title
    Physical parameters of pain in temporalis muscles
    Description
    Trigger points were assessed by palpation of temporal muscle (anterior, middle, and origin).
    Time Frame
    Changes from baseline in pain in temporalis muscles at twelve weeks
    Title
    Physical parameters of lateral condyle pole and temporal tendon insertion pain
    Description
    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.
    Time Frame
    Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks
    Title
    Physical parameters of clicking sound when opening / close palpation
    Description
    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.
    Time Frame
    Changes from baseline in clicking sound when opening / close palpation at twelve weeks
    Title
    Physical parameters of pain in masseter muscles
    Description
    Trigger points were assessed by palpation of masseter muscle (anterior, deep, origin).
    Time Frame
    Changes from baseline in pain in temporalis muscles at twelve weeks
    Title
    Physical parameters of pain in lateral pterygoid muscles
    Description
    Trigger points were assessed by palpation of lateral pterygoid muscle
    Time Frame
    Changes from baseline in pain in lateral pterygoid muscles at twelve weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
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    21178593
    Citation
    Hoffmann RG, Kotchen JM, Kotchen TA, Cowley T, Dasgupta M, Cowley AW Jr. Temporomandibular disorders and associated clinical comorbidities. Clin J Pain. 2011 Mar-Apr;27(3):268-74. doi: 10.1097/AJP.0b013e31820215f5.
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    Leblebici B, Pektas ZO, Ortancil O, Hurcan EC, Bagis S, Akman MN. Coexistence of fibromyalgia, temporomandibular disorder, and masticatory myofascial pain syndromes. Rheumatol Int. 2007 Apr;27(6):541-4. doi: 10.1007/s00296-006-0251-z. Epub 2006 Nov 10.
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    Manfredini D, Tognini F, Montagnani G, Bazzichi L, Bombardieri S, Bosco M. Comparison of masticatory dysfunction in temporomandibular disorders and fibromyalgia. Minerva Stomatol. 2004 Nov-Dec;53(11-12):641-50. English, Italian.
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    Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

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