Temporomandibular Joint Dysfunction Syndrome Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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