Clinical trial NCT02540863: 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
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: myofascial pain syndrome
exercise therapy
randomized controlled trial
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Intensity of pain (100-mm VAS)
timeFrame: Changes from baseline in intensity of pain at twelve weeks
Secondary outcomes:
measure: Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)
timeFrame: Changes from baseline in quality of sleep at twelve weeks
measure: State and trait anxiety (state anxiety questionnaire and trait - STAI)
timeFrame: Changes from baseline in state and trait anxiety at twelve weeks
measure: Physical parameters of active and passive mouth opening
timeFrame: Changes from baseline in active and passive mouth opening at twelve weeks
measure: Physical parameters of pain in temporalis muscles
timeFrame: Changes from baseline in pain in temporalis muscles at twelve weeks
measure: Physical parameters of lateral condyle pole and temporal tendon insertion pain
timeFrame: Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks
measure: Physical parameters of clicking sound when opening / close palpation
timeFrame: Changes from baseline in clicking sound when opening / close palpation at twelve weeks
measure: Physical parameters of pain in masseter muscles
timeFrame: Changes from baseline in pain in temporalis muscles at twelve weeks
measure: Physical parameters of pain in lateral pterygoid muscles
timeFrame: Changes from baseline in pain in lateral pterygoid muscles at twelve weeks
Other outcomes:
Locations:
Study officials:
References:
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