Miofascial Release and Exercises Therapy in the Treatment of Temporomandibular Disorders

September 15, 2015 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: myofascial release protocol and Rocabado exercise therapy

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.
Other: myofascial release protocol and Rocabado exercise therapy
Active Comparator: exercise therapy
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.
Other: exercise therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Changes from baseline in intensity of pain at twelve weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Changes from baseline in quality of sleep at twelve weeks
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).
Changes from baseline in state and trait anxiety at twelve weeks
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.
Changes from baseline in active and passive mouth opening at twelve weeks
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).
Changes from baseline in pain in temporalis muscles at twelve weeks
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.
Changes from baseline in Lateral condyle pole and temporal tendon insertion pain at twelve weeks
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.
Changes from baseline in clicking sound when opening / close palpation at twelve weeks
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).
Changes from baseline in pain in temporalis muscles at twelve weeks
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
Changes from baseline in pain in lateral pterygoid muscles at twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-427

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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