Sleep evaluation, pain and electrical activity of the masticatory muscles in temporomandibular dysfunction and fibromyalgia.

Category Primary study
Registry of TrialsANZCTR
Year 2010
INTERVENTION: Fibromyalgia volunteers will be classified with Temporomandibular Disorders by Research Diagnostic Criteria for Temporomandibilar Disorders (RDC/TMD); Then respond to the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI) and quality of life questionnaire (SHORT‐FORM 36 – MEDICAL OUTCOME STUDY) and will be submitted to electromyographic analysis of anterior temporal and masseter muscles before and after the treatment period. The subjects will be randomly divided into two groups equal in number and the characteristics of individuals. First, we will test hypothesis with a case control study. The subjects will be randomly divided into two groups: Therapeutic Group (n=14) and the Placebo Group (n=14) with the same parameters of following treatment study. If the therapeutic treatment provide pain relief or show benefits for patients, we will start the treatment period with larger sample. If not, we will stop the therapeutic protocol and will terminate the survey. Thereby, at the next phase of the treatment, group A (n=25) will receive a therapeutic protocol consisting in applying High Voltage Pulsate Stimulation (HVPS) (phase (T) = 100 microvolts, frequency of100Hz, intensity of 100 volts) This treatment will consist of four sessions, 1 time per week for 30 minutes and the active electrodes are placed on the anterior temporalis and masseter muscles and dispersive electrodes in the region of trapezius muscle. Already the group B (n=25) receive the placebo protocol. At the end of the period proposed both groups remain 15 days without any intervention. After this period, the treatment will be applied backwards, so the group A will receive a placebo protocol and group B will receive the treatment protocol (crossover trial). Seven days before the start of the study in both groups, there will be a baseline for assessment of pain by visual analog scale, which will be reapplied before and after each session. CONDITION: Fibromyalgia Temporomandibular disorders sleep disorders PRIMARY OUTCOME: Classification found in fibromyalgia patients by RDC / TMD is myofascial pain (group 1A) To assess the quality of sleep was used the Pittsburgh Sleep Quality Index (PSQI). Results: PSQI > 5 (poor quality of sleep) SECONDARY OUTCOME: none INCLUSION CRITERIA: females with fibromyalgia and TMD
Epistemonikos ID: 7261ea442ee98757454ad660a40d13126047e23c
First added on: Aug 25, 2024