Protocol summary

Study aim
Comparison of therapeutic effects of M1 and Bifrontal transcranial direct current stimulation montages in treatment of shoulder girdle myofacial syndrom
Design
A randomized, blinded, sham controlled clinical trial with a parallel group design of 60 patients
Settings and conduct
The studied patients will be selected from all the patients referred to the physical medicine and rehabilitation clinics of tabriz university of medical sciences, in which the inclusion and exclusion criteria applied and they will be willing to participate in the study. Patients will be studied in two groups with different assemblies and the third group as Sham therapy. For blinding patients and analyzer, information about the type of assembly or sham treatment, will not be provided.
Participants/Inclusion and exclusion criteria
1. Diagnosis of chronic myofascial pain in the shoulder girdle. 2. A history of at least 3 months of pain due to shoulder girdle myofascial pain syndrome. 3. Spontaneous pain in at least one of the trigger points in the trapezius, supraspinatus, rhomboid, and levator scapulae muscles. 4. Use of stable dose of painkillers, at least 3 months prior to the study. 5. Pain intensity of 5 or greater with VAS criteria over the past week. 6. Age between 18 and 50 years old.
Intervention groups
Patients will be studied in three groups, A, B and C. Group A will be treated with the first type of montage, group B will be treated with second type montage and group C will be treatment as sham therapy.
Main outcome variables
1. Investigating the therapeutic effects of Bifrontal TDCS and M1 TDCS montages on pain relief, pain pressure threshold and pain self perception in patients with shoulder girdle myofascial pain syndrome and to comparison the therapeutic effects of these two montages.

General information

Reason for update
Acronym
TDCS
IRCT registration information
IRCT registration number: IRCT20081004001292N6
Registration date: 2020-06-06, 1399/03/17
Registration timing: registered_while_recruiting

Last update: 2020-06-06, 1399/03/17
Update count: 0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Vahideh Toopchizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 984113335625
Email address
toopchi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects of M1 and Bifrontal transcranial direct current stimulation montages in treatment of shoulder girdle myofacial syndrome: A randomized clinical trial.
Public title
Comparison of the therapeutic effects of M1 and Bifrontal TDCS in the treatment of patients with shoulder girdle myofascial syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic myofascial pain in the shoulder girdle. A history of at least 3 months of pain due to shoulder girdle myofascial pain syndrome. Spontaneous pain in at least one of the trigger points in the trapezius, supraspinatus, rhomboid, and levator scapulae muscles. Use of stable dose of painkillers, at least 3 months prior to the study. Pain intensity of 5 or greater with VAS criteria over the past week. Age between 18 and 50 years old.
Exclusion criteria:
Previous diagnosis of shoulder pathology other than MPS that can help with pain, including partial dislocation, instability, fracture, frozen shoulder, infection and inflammation. Cervical radiculopathy based on clinical examinations. Diagnosis of neurological diseases such as Alzheimer's or Parkinson's. Severe psychological conditions or symptoms such as schizophrenia, major depression or mania. Current pregnancy or lactation. History of seizures. Defects in the skull bone. Existence of skin scar at the electrode installation site. Tumors in the tissue of the areas below the electrode. Current use of herbal remedies or other alternative therapies such as recent topical injections for pain.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize patients, 60 envelopes will be prepared and numbered from one to 60. Using a table of random numbers, patients will be divided into three groups, A, B, and C. According to the table obtained, the group for each number will be written in the envelope. A list of the number of patients will be prepared and as patients enter the study, patient envelope number will be open and the patient will be placed in the specified group.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the patients, they will not receive information about whether the treatment is Sham or the difference in the type of montages. In blinding analyzer, the type of montages or the type of therapy (Sham or true) received by patients will not be provided to the analyzer.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of Medicine, Next to Imam Reza Hospital/Golgasht Avenue/ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.TBZMED.REC.1399.168

Health conditions studied

1

Description of health condition studied
Myofascial pain syndrome
ICD-10 code
M79.1
ICD-10 code description
Myalgia

2

Description of health condition studied
Myofascial pain syndrome
ICD-10 code
G89.4
ICD-10 code description
Chronic pain syndrome

Primary outcomes

1

Description
Pain threshold
Timepoint
Before and immediately after the intervention
Method of measurement
Wagner digital Pain algometer

2

Description
Self-Perception of improvement
Timepoint
Before and immediately after the intervention
Method of measurement
Pain Self-Efficacy Questionnaire (PSEQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention First group: transcranial direct current stimulation M1 montage
Category
Treatment - Devices

2

Description
Intervention Second group: transcranial direct current stimulation Bifrontal montage
Category
Treatment - Devices

3

Description
Control group: ُSham therapy
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Phisycal Medicine and Rehabilitation clinic of Emam Reza hospital
Full name of responsible person
Fariba Eslamian
Street address
Emam Reza hospital, Golgasht avenue, Azadi sreet
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 5081
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiee
Street address
Faculty of Medicine, Next to Imam Reza Hospital/Golgasht Avenue/ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7311
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Izadseresht
Position
Rezident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital/Golgasht Avenue/ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 8029
Email
b.izadseresht@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Toopchizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Faculty of Medicine, Next to Imam Reza Hospital/Golgasht Avenue/ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 5081
Email
toopchi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Izadseresht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital/Golgasht Avenue/ Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3326 8029
Email
b.izadseresht@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data will be shared after contestants are anonymoused
When the data will become available and for how long
I haven't decided yet
To whom data/document is available
Only for researchers working in academic institutions
Under which criteria data/document could be used
There are no other conditions.
From where data/document is obtainable
Email the person in charge of updating.
What processes are involved for a request to access data/document
The release schedule is unknown
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