Temporomandibular Joint Dysfunction Syndrome Clinical Trial
Official title:
Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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