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

This study has been completed.
Sponsor:
Collaborators:
Universidad de Granada
Andaluz Health Service
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, Universidad de Almeria
ClinicalTrials.gov Identifier:
NCT01800279
First received: February 19, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Temporomandibular Joint Dysfunction Syndrome
Other: Physiotherapy Protocol
Other: Deontology Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

Resource links provided by NLM:


Further study details as provided by Universidad de Almeria:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Temporomandibular Dysfunction. [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]

    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.

  • Quality of Life (SF-36) [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Index of Widespread Pain and Symptom Severity [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Physical Function. [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Quality of Sleep. [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Rates of Depression [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]

    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

  • State-Trait Anxiety. [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Clinical Impression of Severity. [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Clinical Global Impression Improvement. [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 70
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800279

Locations
Spain
Fibromyalgia Association (AGRAFIM)
Granada, Almeria, Spain, 04120
Sponsors and Collaborators
Universidad de Almeria
Universidad de Granada
Andaluz Health Service
Investigators
Study Director: Adelaida M Castro-Sánchez, PhD University of Almería
  More Information

Publications:

Responsible Party: Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
ClinicalTrials.gov Identifier: NCT01800279     History of Changes
Other Study ID Numbers: UAL-12
Study First Received: February 19, 2013
Last Updated: December 9, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Universidad de Almeria:
Fibromyalgia Syndrome, Temporomandibular Joint, Pain.

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Joint Diseases
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014