Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

December 9, 2013 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design: randomized clinical trial. Objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (FMS).

Background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with FMS are controversial. Descriptive data and intervention studies are still scarce.

Methods and measures: sixty patients will be randomly assigned to experimental or control group. The experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). Pain levels, impact of FMS symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups independent Student t-test for continuous data and χ2 tests of independence for categorical data. Separate 2x2 mixed model ANCOVAs with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Almeria
      • Granada, Almeria, Spain, 04120
        • Fibromyalgia Association (AGRAFIM)

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of fibromyalgia syndrome.
  • Agreement to attend evening therapy sessions.
  • 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.

Exclusion Criteria:

  • History of recent trauma.
  • Therapeutic co-interventions during treatment.
  • Indication for surgical treatment of temporomandibular joint.
  • Edentulism.
  • Physical or mental illness that precludes attendance at therapy sessions.

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deontology Therapy
The patients in the control group will port a deprogramming occlusal splint to sleep every night, an average of 8 hours per day, for 12 weeks of the treatment.
Other: Deontology Therapy

For the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain):

  • Impression of the maxilla with chromatic alginate "Phase plus" (Zhermack ©, Rovigo, Italy).
  • Emptying working models in plaster-stone type IV "Elite Rock" (Zhermack ©, Rovigo, Italy).
  • Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate "The Machine" Dentaflux ©, Ripoll, Madrid.
Experimental: Physiotherapy Protocol
The physiotherapy protocol involves the application of kinesitherapy techniques and a myofascial therapy protocol. This protocol will be administered twice a week for 12 weeks.
Other: Physiotherapy Protocol

Kinesitherapy

  • Patient: supine position on the stretcher with a loop of 6 cm in the cervical area.
  • Tongue in the palate for all applied exercises.
  • Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). Opening movement with a small resistor (one finger on chin).

Flexion of the head, without actually lifting, resisting in the front. Occipital extension. Cranium fore flexion 15 °. Cervical traction.

Myofascial Therapy. Induction suboccipital. Compression - decompression of the TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: At baseline and 12 weeks
The visual analog scale (VAS), designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 for pain-free and 100 for maximum pain.
At baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporomandibular Dysfunction.
Time Frame: At baseline and 12 weeks

Dworkin and LeResche present a multiaxial evaluation system that integrates the relevant aspects for the temporomandibular dysfunction in two axes. The exploration model consists of a protocol detailing the tests to be applied, and other specifications of the procedure to be followed by the professional:

  1. Temporomandibular pain.
  2. Pattern jaw opening.
  3. Vertical movement range.
  4. Sounds of the temporomandibular joint in palpation during vertical movement.
  5. Mandibular excursive movements.
  6. Pain extraoral muscle tenderness.
  7. Joint pain on palpation.
  8. Muscle pain during intraoral palpation.
At baseline and 12 weeks
Quality of Life (SF-36)
Time Frame: At baseline and 12 weeks
The assessment of Quality of Life (SF-36) covers 8 dimensions of health status. It contains 36 items covering two areas, the functional status and the emotional wellness. The area of the functional state is represented by the following dimensions: physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items). The wellness area includes the dimensions of mental health (5 items), vitality (4 items), pain (2 items). Finally, the general health assessment includes the dimension of perception of general health (5 items) and the health change over the time (one item, which is not part of the final score).
At baseline and 12 weeks
Index of Widespread Pain and Symptom Severity
Time Frame: At baseline and 12 weeks
This simple clinical case definition of fibromyalgia properly classifies the 88.1% of the cases classified by the ACR (American College of Rheumatology) classification criteria, and it does not require a physical or tender point. The symptom severity score allows the assessment of the severity of the symptoms of fibromyalgia in people with current or previous fibromyalgia, and those in which the criteria have not been applied yet. This questionnaire is especially useful in the longitudinal assessment of patients with marked symptom variability.
At baseline and 12 weeks
Physical Function.
Time Frame: At baseline and 12 weeks
The fibromyalgia impact questionnaire (FIQ) consists of 10 items. The first item is composed of 11 subitems in which is valued the physical function. In the second and third items, patients indicate the number of days in which they disrupt their daily activity due to pain, or otherwise the days they find improvement. The impact caused by the symptoms of fibromyalgia in the physical and mental health of the patients was measured by the Spanish version of the Impact of Fibromyalgia Questionnaire. The FIQ assesses the following dimensions: feeling good, physical function, missing work and work capacity, physical, psychological and social components and global wellness. Also, it includes six visual analog scales for assessing fatigue, pain, stiffness, morning tiredness, anxiety and depression.
At baseline and 12 weeks
Quality of Sleep.
Time Frame: At baseline and 12 weeks
Pittsburgh Sleep Quality Index Questionnaire (PSQI) consists of 24 items, and which interrogate issues such as the quality of sleep that the subject he has, or the frequency of certain events - such as difficulty falling asleep during the first half an hour or the presence of nightmares- are answered by an ordinal scale with four grades. In the correction of this questionnaire, seven scores are obtained which inform us of the components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of hypnotic medication, and daytime dysfunction. Each of these components receives a discrete score which can range from 0 to 3. A score of 0 indicates that there are no problems in this respect, and a score of 3 indicates serious problems at that level. The sum of the scores in each partial component generates a total score, which can range from 0 to 21.
At baseline and 12 weeks
Rates of Depression
Time Frame: At baseline and 12 weeks

The Beck inventory for depression is a self-administered questionnaire of 21 items that assesses a wide range of depressive symptoms. Its content emphasizes more the cognitive component of depression, and the symptoms of this area represent about 50% of the total score of the questionnaire, with symptoms of somatic / vegetative. In the second block, of the 21 items, 15 refer to eco-cognitive symptoms, and the remaining 6 to somatic-vegetative symptoms. Each item has four response alternatives listed from low to high severity, assessing the severity / intensity of the symptom. The range of the score is 0-63 points. The aim of this questionnaire is to quantify the symptoms, not provide a diagnosis. The breakpoints usually accepted to graduate the intensity/severity are the followings:

  • No Depression: 0-9 points.
  • Mild depression: 10-18 points
  • Moderate Depression: 19-29 points
  • Severe depression: ≥ 30 points
At baseline and 12 weeks
State-Trait Anxiety.
Time Frame: At baseline and 12 weeks
The State-Trait Anxiety Inventory (STAI) measures a stable personality dimension (trait anxiety or tendency to anxiety), also includes a subscale of state, to detect anxiety behaviors. In the questionnaire, consisting of 40 items (20 for each level), the subjects have to describe how they feel generally, in the case of the trait anxiety scale, and how they feel when they answer, in the case of anxiety scale as a state. The STAI allows obtaining the scores of both scales separately.
At baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Impression of Severity.
Time Frame: At baseline and 12 weeks
The clinical impression of severity scale assesses the severity level regarding the patient's physical condition. It comprises a Likert scale extending from a value of 1 (no disease) to a value of 7 (extremely ill).
At baseline and 12 weeks
Clinical Global Impression Improvement.
Time Frame: At baseline and 12 weeks
The clinical global impression of improvement allows to evaluate the improvement perceived by the patient. It comprises a Likert scale which extends from a value of 1 (very much improved) to a value of 7 (extremely ill).
At baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

Universidad de Almeria

Collaborators

Andaluz Health Service
Universidad de Granada

Investigators

  • Study Director: Adelaida M Castro-Sánchez, PhD, Universidad de Almería

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

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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