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

Effect of high voltage pulsed current stimulation on pain, quality of life, and electrical activity of the anterior temporal and masseter muscles in females with fibromyalgia, temporomandibular disorders and sleep disorders.

Status

Suspended

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000517077

Enrollment

Registered

2010-06-23

Start date

2013-05-31

Completion date

2013-10-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

For this project will be selected 50 women with fibromyalgia treated in the Center for Advanced Study of Sleep (Sao Paulo/SP- Brazil). 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) and will be submitted to electromyographic analysis of anterior temporal and masseter muscles before and after the treatment period. 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. Then, the subjects will be randomly divided into two groups equal in number and the characteristics of individuals. In the first phase of the treatment, group A (n=25) receive a therapeutic protocol consisting in applying High Voltage Pulsate Stimulation (HVPS) (T = 100 microvolts, f = 100Hz, 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 muscles studied 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. It is expected that the application HVPS in individuals with fibromyalgia, sleep disturbances, and temporomandibular disorder, promote pain relief, improved sleep quality and balance of the electromyographic signal, with consequent improvement in quality of life in these patients compared the placebo group.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

females with fibromyalgia and TMD

Exclusion criteria

systemic diseases, exposure to macro facial trauma, joint dislocation, use of braces, dental pain, presence of sinusitis, ear infections, malignancies, lupus erythematosus and hormonal disorders.

Outcome results