Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000517077
Ethics application status
Approved
Date submitted
17/06/2010
Date registered
23/06/2010
Date last updated
4/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep evaluation, pain and electrical activity of the masticatory muscles in temporomandibular dysfunction and fibromyalgia.
Scientific title
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.
Secondary ID [1] 252024 0
nil
Universal Trial Number (UTN)
U1111-1115-4974
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorders 257567 0
Fibromyalgia 257568 0
sleep disorders 257581 0
Condition category
Condition code
Musculoskeletal 257726 257726 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256661 0
Diagnosis / Prognosis
Intervention code [2] 256662 0
Treatment: Other
Intervention code [3] 256671 0
Other interventions
Comparator / control treatment
placebo protocol consist of the same treatment protocol, but HVPS intensity of 0 volts. (four sessions, 1 time per week for 30 minutes)
Control group
Placebo

Outcomes
Primary outcome [1] 258627 0
Classification found in fibromyalgia patients by RDC / TMD is myofascial pain (group 1A)
Timepoint [1] 258627 0
At one month after randomisation and this outcome is assessed at baseline.
Primary outcome [2] 258628 0
To assess the quality of sleep was used the Pittsburgh Sleep Quality Index (PSQI). Results: PSQI > 5 (poor quality of sleep)
Timepoint [2] 258628 0
at one month after randomisation and this outcome is assessed at baseline.
Secondary outcome [1] 264594 0
none
Timepoint [1] 264594 0
none

Eligibility
Key inclusion criteria
females with fibromyalgia and TMD
Minimum age
20 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients received numbers corresponding to their records by project administrator who was "off-site", which were unknown from operators who would apply the treatments and evaluations. The allocation concealment procedure used was done of following manner:
First patients received numbers corresponding to their records for treatment phase. Then, simple randomization using dice-rolling procedures was performed. After, during evaluation phase, new numbers were given to their records which were unknown from operators who would apply the treatments and evaluations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using dice-rolling procedures was performed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
5/01/2010
Actual
31/05/2013
Date of last participant enrolment
Anticipated
31/10/2013
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2699 0
Brazil
State/province [1] 2699 0
Sao Paulo/ Piracicaba

Funding & Sponsors
Funding source category [1] 257143 0
Hospital
Name [1] 257143 0
Clinical Hospital of University of Sao Paulo (HC-FMUSP)
Country [1] 257143 0
Brazil
Primary sponsor type
University
Name
Piracicaba Dental School State University of Campinas, Brazil
Address
Avenue Limeira, 901
Piracicaba/SP
CEP: 13414-903
Country
Brazil
Secondary sponsor category [1] 256403 0
Hospital
Name [1] 256403 0
Clinical Hospital of University of Sao Paulo (HC-FMUSP)
Address [1] 256403 0
Avenue Dr. Eneas de Carvalho Aguiar 255, Cerqueira Cesar
05403-000 Sao Paulo - Brazil
Country [1] 256403 0
Brazil
Other collaborator category [1] 1330 0
Other
Name [1] 1330 0
Capes- Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior
Address [1] 1330 0
Setor Bancario Norte, Quadra 2, Bloco L, Lote 06, CEP 70040-020 - Brasilia, DF
Country [1] 1330 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259186 0
the ethics committee in research of the school of dentistry of Piracicaba - State University of Campinas
Ethics committee address [1] 259186 0
Avenue Limeira, 901 Areiao
Piracicaba/SP
Brazil
CEP: 13414-903
Ethics committee country [1] 259186 0
Brazil
Date submitted for ethics approval [1] 259186 0
12/07/2009
Approval date [1] 259186 0
12/08/2009
Ethics approval number [1] 259186 0
103/2009

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31290 0
Prof Maisa Soares Gui
Address 31290 0
Street Joao Bueno Filho 41 Jardim Montezuma Limeira SP 13480-358
Country 31290 0
Brazil
Phone 31290 0
5519981710130
Fax 31290 0
Email 31290 0
maisa_gui@yahoo.com.br
Contact person for public queries
Name 14537 0
Prof maisa soares gui
Address 14537 0
Street Joao Bueno Filho 41
Jardim Montezuma
Limeira SP
13480-358
Country 14537 0
Brazil
Phone 14537 0
55 (19) 81710130
Fax 14537 0
Email 14537 0
maisa_gui@yahoo.com.br
Contact person for scientific queries
Name 5465 0
Prof maisa soares gui
Address 5465 0
Street: Joao Bueno Filho 41
Jardim Montezuma
Limeira SP
13480-358
Country 5465 0
Brazil
Phone 5465 0
55 (19) 81710130
Fax 5465 0
Email 5465 0
maisa_gui@yahoo.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIFacial Pain Associated With Fibromyalgia Can Be Marked by Abnormal Neuromuscular Control: A Cross-Sectional Study2013https://doi.org/10.2522/ptj.20120338
N.B. These documents automatically identified may not have been verified by the study sponsor.