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Clinical Trials/NCT02540863
NCT02540863CompletedNot Applicable

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

Universidad de Almeria0 sites64 target enrollmentStarted: June 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Primary Endpoint
Intensity of pain (100-mm VAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

myofascial release protocol and Rocabado exercise therapy

Experimental

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.

Intervention: myofascial release protocol and Rocabado exercise therapy (Other)

exercise therapy

Active Comparator

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: exercise therapy (Other)

Outcomes

Primary Outcomes

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

  • Physical parameters of active and passive mouth opening(Changes from baseline in active and passive mouth opening at twelve weeks)
  • Physical parameters of pain in masseter muscles(Changes from baseline in pain in temporalis muscles at twelve weeks)
  • State and trait anxiety (state anxiety questionnaire and trait - STAI)(Changes from baseline in state and trait anxiety at twelve weeks)
  • Physical parameters of pain in lateral pterygoid muscles(Changes from baseline in pain in lateral pterygoid muscles at twelve weeks)
  • Quality of Sleep (Pittsburgh Sleep Quality Index - PSQI)(Changes from baseline in quality of sleep at twelve weeks)
  • Physical parameters of pain in temporalis muscles(Changes from baseline in pain in temporalis muscles at twelve weeks)
  • Physical parameters of lateral condyle pole and temporal tendon insertion pain(Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks)
  • Physical parameters of clicking sound when opening / close palpation(Changes from baseline in clicking sound when opening / close palpation at twelve weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adelaida María Castro-Sánchez

PhD (Lecturer)

Universidad de Almeria

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