An interventional study of Multidisciplinary therapy and Placebo in Temporomandibular Joint Dysfunction Syndrome, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-11.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.
Design: Randomized clinical trial. Objective: to compare the therapeutic effects of physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome.
Methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. The experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. Pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with independent Student t-test for continuous data and chi-square tests of independence for categorical data. Separate 2x3 model ANOVA with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universidad de Almeria is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
The multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks.
Other: Multidisciplinary therapy
A physiotherapist administered 15 sessions of "induction occipital" once a week.
Other: Placebo
Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), 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 temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid. Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks.
Change on pain intensity
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
Time frame: At baseline, 15 weeks and 20 weeks
Change in temporomandibular dysfunction
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: temporomandibular pain, pattern jaw opening, vertical movement range, sounds of the temporomandibular joint in palpation during vertical movement, mandibular excursive movements, pain extraoral muscle tenderness, joint pain on palpation, muscle pain during intraoral palpation.
Time frame: At baseline, 15 weeks and 20 weeks
Change in quality of life SF-36
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).
Time frame: At baseline, 15 weeks and 20 weeks
Change on index of widespread pain and symptom severity
This simple clinical case definition of fibromyalgia properly classifies the 88.1% of the cases classified by the 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.
Time frame: At baseline, 15 weeks and 20 weeks
Change in physical function
The fibromyalgia impact questionnaire 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. This questionnaire 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.
Time frame: At baseline, 15 weeks and 20 weeks
Change on quality of sleep
Pittsburgh Sleep Quality Index Questionnaire 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.
Time frame: At baseline, 15 weeks and 20 weeks
Change on rates of depression
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
Time frame: At baseline, 15 weeks and 20 weeks
Change on state-trait anxiety
The State-Trait Anxiety Inventory 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. This inventory allows obtaining the scores of both scales separately.
Time frame: At baseline, 15 weeks and 20 weeks
Change in clinical impression of severity
This 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).
Time frame: At baseline, 15 weeks and 20 weeks
Change in clinical global impression of improvement
This scale 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).
Time frame: 15 weeks and 20 weeks after intervention
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria