Comparing effect of transcranial direct current stimulation (TDCS ) and repetitive transcranial magnetic stimulation (RTMS ) on pain reduction and improvement the quality of life in patients with Fibromyalgia
Design
This is double blinded clinical trial,with parallel groups ,with 30 patients suffering fibromyalgia , referring to the physical medicine and rehabilitation clinics of IRAN university of medical sciences in 1396-97 .The patients are divided into 2 parallel groups by block randomization using sealed envelopes, and follow up are considered for 6 and 12 weeks later.The inclusion criteria are age over18 years and vas>4 .Follow up is performed after 3 session of treatment ,6 and12 weeks later.
Settings and conduct
Our study is performed on the patients with Fibromyalgia, referring to physical medicine and rehabilitation clinics of Iran university medical sciences during 1396-97.Blinding is applied on the patients and analyzer( they do not know about 2 different methods of stimulation).The patients are divided into 2 groups by block randomization using sealed envelopes.
Participants/Inclusion and exclusion criteria
Patient over 18 y/o with fibromyalgia with an Visual analog scale (VAS>4),who have no severe diseases that may interfere with the study and do not have a metal implant
Intervention groups
Patients are randomly divided into 2groups:
group A: 3 sessions of TDCS . The anode is placed on the left Dorsolateral prefrontal cortex (DLPFC) ,and the cathode is placed on the right supraorbital region.stimulation is performed with intensity 2 mA and dose 40 for 20 minutes.
group B: 3 sessions of RTMS. stimulation is given on the left DLPFC with high frequency (10 Htz) ,intensity 100% of the threshold, rest time of 15 second and a total pulse of 1000 .Also patient perform specific exercises.
Main outcome variables
1.pain
2.quality of life
3. anxiety and depression
4.health condition
General information
Reason for update
Acronym
TDCS
IRCT registration information
IRCT registration number:IRCT20180220038802N1
Registration date:2018-12-02, 1397/09/11
Registration timing:retrospective
Last update:2018-12-02, 1397/09/11
Update count:0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Hosnieh Haqiqat shenas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5579 4307
Email address
hosnie64.haq23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-25, 1396/11/05
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-01-25, 1396/11/05
Actual recruitment end date
2018-06-30, 1397/04/09
Trial completion date
2018-09-22, 1397/06/31
Scientific title
Comparison of the effectiveness of RTMS and TDCS in decreasing pain and improving quality of life in fibromyalgia patients
Public title
Effect of TDCS in treatment of fibromyalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American college of rheumatology 's criteria for fibromyalgia
Age >18
VAS >=4 (1week before study)
Exclusion criteria:
The patient desire to leave the study at each stage of the plan
major depression ( beck score>30) or psychosis
Diseases that disrupts the process ,such as diagnosed DM ,heart ,liver , pulmonary or kidney diseases
Pregnancy and lactation
Metal implant
History of seizure or epilepsy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using sealed envelopes into 2 groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and person who analyze data, do not know about the distribution of patients to the tow treatment groups with electrical and magnetic stimulation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-01-21, 1396/11/01
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511524003
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
The severity of pain
Timepoint
Zero, The last day of treatment, 6 and 12 weeks later
Method of measurement
Visual analog scale (vas)
2
Description
The quality of life
Timepoint
Zero ,6 and 12 weeks later
Method of measurement
By SF36 questionnare
3
Description
The depression and anxiety
Timepoint
Zero, 6 and 12 weeks later
Method of measurement
DASS questionnare
4
Description
Health condition in fibromyalgia
Timepoint
Zero, 6 and 12 weeks later
Method of measurement
FIQ questionnare
Secondary outcomes
1
Description
Side effects
Timepoint
6 and 12 weeks later
Method of measurement
Physical exam
Intervention groups
1
Description
Intervention group: Brain electrical stimulation using TDCS (Transcranial direct current stimulation)in left DLPFC (Dorsolateral prefrontal cortex) , which will be done by an experienced physical medicine and rehabilitation specialist.
Category
Treatment - Other
2
Description
Control group: Brain magnetic stimulation by RTMS(Repetitive transcranial magnetic stimulation) in left DLPFC ,which will be done by an experienced physical medicine and rehabilitation specialist
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Dr .Hosnie Haghighatshenas
Street address
Department of Physical Medicine and Rehabilitation , Firuzgar Hospital , Valiasr Square ,Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
hosnie64.haq23@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Javad Ali Musavi
Street address
5th floor, Headquarters,Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5503
Fax
+98 21 8862 2703
Email
Dr.Sajadi_PMR@Yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Hosnie Haghighatshenas
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square ,Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
Hosnie64.Haq23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Simin Sajjadi
Position
Associated Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square , Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
Dr.Sajadi_pmr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Hosnie Haghighatshenas
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation ,Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
Hosnie64.Haq23@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After unidentified participants ,data can be shared.
When the data will become available and for how long
After the results are published.
To whom data/document is available
People working in academic institute
Under which criteria data/document could be used
If other researchers want to perform additional analysis on the data, other than published, their request will be discussed in an authors meeting
From where data/document is obtainable
Via investigator's email (dr.sajadi_pmr@yahoo.com)
What processes are involved for a request to access data/document
The applicant should email his/her request and the reason for doing it.