Comparison of pain, quality of life and functional scores between two groups
Design
After giving the necessary explanations, a signed written consent is obtained from the mentioned patients, and then they are treated with tDCS or control by block randomization method.
Settings and conduct
This double-blinded randomized clinical trial will be performed in Imam Reza Hospital in Tehran in 1400
Participants/Inclusion and exclusion criteria
Adult patients aged 20-65 years
Pain for at least 6 weeks
MRI-confirmed inflammation of the shoulder tendon
Pregnancy and lactation
Complete rupture of the rotator cuff
The presence of active infection in the shoulder joint or surrounding tissues
Coagulation disorders and the use of anticoagulants
Cervical Radiculopathy
Systemic rheumatic disorders
Contraindications to tDCS
Metal or electronic implants
peace maker
Pregnancy
History of epilepsy
Intervention groups
The treatment is in 5 sessions using a 35 centimeter square electrode with a current of 2 milliamp. During intervention, the anode electrode is placed on the primary motor cortex on the opposite side of the most painful side and the cathode is placed on the opposite super-orbital, which of course has a protective sponge. In the tDCS group, the excitation rate reaches 2.5 milliamp from zero in the first 10 seconds, and this excitation lasts for 20 minutes and then reaches zero in 10 seconds. In the Sham group, the excitation rate reaches 2.5 milliamp from zero in the first 10 seconds, and this excitation lasts for 30 seconds and then reaches zero in 10 seconds. The duration of using active tDCS for intervention and control groups will be 20 minutes and 30 seconds respectively. However, the total time for electrode usage for patients in both groups will be equal to 20 minutes.
Main outcome variables
visual analogue scale (VAS)
The Disabilities of the Arm, Shoulder and Hand (DASH)
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039324N3
Registration date:2021-09-02, 1400/06/11
Registration timing:registered_while_recruiting
Last update:2021-09-02, 1400/06/11
Update count:0
Registration date
2021-09-02, 1400/06/11
Registrant information
Name
Sirous Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3476
Email address
s.azizi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of tDCS and Sham tDCS in reducing pain and improving patient symptoms with shoulder tendinopathy
Public title
Comparison of tDCS and Sham tDCS in reducing pain and improving patient symptoms with shoulder tendinopathy referred to Imam Reza Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients aged 20-65 years
Pain at least 6 weeks
MRI-confirmed shoulder tendonitis
Exclusion criteria:
Pregnancy and lactation
Complete rotator cuff rupture
History of tumor and malignancy
Active infection in the shoulder joint or surrounding tissues
Coagulation disorders and using anticoagulant drugs
cervical radiculopathy
Systemic rheumatic disorders
Contraindications to tDCS such as metal or electronic implants, pacemakers, pregnancy and history of epilepsy
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to tDCS or Sham by block randomization in one of two groups. To randomly assign two groups with 20 participants in each group (40 patients in total), we use block randomization with different block sizes. The size of the blocks is a multiple of 2 and a divisor of 40 (2,4,8). Initially, the size of the blocks is randomly selected. Then for each block, different permutations are determined for the size of the equal group. Finally, one of the permutations is randomly selected. Random numbers are generated using a computer in an independent statistical unit.
Blinding (investigator's opinion)
Double blinded
Blinding description
The tDCS electrodes are placed at the predefined locations for the two groups in a similar manner for 20 minutes. In the tDCS group the active current time will be 20 minutes and in the SHAM group, it will be 30 seconds. Evaluators will also be unaware of the group allocations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of AJA University of Medical Sciences
Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
Primary outcomes
1
Description
visual analogue scale
Timepoint
before intervention, 1 month after intervention, 3 months after intervention
Method of measurement
A 10-point VAS scale that the patient should give a score from 0 to 10
2
Description
The Disabilities of the Arm, Shoulder and Hand (DASH)
Timepoint
before intervention, 1 month after intervention, 3 months after intervention
Method of measurement
DASH Questionnaire with 21 questions
3
Description
world health organization quality of life questionnaire (WHOQOL-BREF)
Timepoint
before intervention, 1 month after intervention, 3 months after intervention
Method of measurement
world health organization quality of life (WHOQOL-BREF) with 30 items
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The treatment is in 5 sessions using a 35 cm square electrode with a current of 2 miliAmp. During this intervention, the anode electrode is placed on the primary motor cortex on the opposite side of the most painful side and the cathode is placed on the opposite super-orbital side, which of course has a protective sponge and the width of the sponges is 16 square centimeters on the skin. The patient is placed and electrode contact is made with the patient. In the tDCS group, the excitation rate reaches 2.5 miliAmp from zero in the first 10 seconds, and this excitation lasts for 20 minutes and then reaches zero in 10 seconds.
Category
Treatment - Devices
2
Description
Control group: In the control group, in the initial 10 seconds, the excitation rate reaches 2.5mA from zero, and this excitation continues for 30 seconds, and then reaches zero in 10 seconds. The duration of use of tDCS will be 20 minutes and the duration of use will be only 30 seconds.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Tehran
Full name of responsible person
Leyla Yarmohamadi
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mostafa Shahrezaee
Street address
Medical University for the Islamic Republic of Iran's Army, Etemadzadeh Avenue, West Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
moshahrezayee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Leyla Yarmohammadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Leyla Yarmohammadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Leyla Yarmohammadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza hospital, Etemad zade street, Fatemi street
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Smt.1368@gmail.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
Undecided - It is not yet known if there will be 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