Comparative study the effect of active and sham transcranial direct current stimulation (tDCS) on disability, anxiety and kinesiophobia in athletes with chronic shoulder injury
Determining the effect of active and sham transcranial direct current stimulation and comparing them on disability, anxiety, and kinesiophobia in athletes with a history of chronic shoulder injury
Design
A parallel-group, double-blind, randomized controlled clinical trial of 36 patients. Permuted block randomization method is used for randomization.
Settings and conduct
This study will be conducted with the voluntary participation of athletes with a history of chronic shoulder injury who have a fear of movement. In the intervention group, the treatment protocol includes the use of real tDCS (direct current transcranial stimulation) on the DLPFC area of the head, and in the control group, fake tDCS (sham). the patients will be treated in 10 sessions. The first 5 sessions will be consecutive and the next 5 sessions will be one day apart. Disability, anxiety, and kinesiophobia will be assessed before and after the intervention and one month after the end of the study (follow-up). Patients and the evaluator are blinded to the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range between 18 and 35 years; having a score of 37 in the Tampa questionnaire; Not receiving psychological treatment in the past year.
Exclusion criteria: Having prosthesis in skull; having cardiac pacemaker; acute shoulder injury.
Intervention groups
]n the intervention group, a direct stimulation current will be used by a pair of electrodes (cathode and anode). A current of 2 mA is applied to the left DLPFC for 20 minutes. In the control (sham) group, the current is first applied for 2 minutes, then the device is turned off.
Main outcome variables
Kinesiophobia; disability; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221023056277N1
Registration date:2022-11-14, 1401/08/23
Registration timing:prospective
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Amin Mottahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 8090
Email address
aminmotahedii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study the effect of active and sham transcranial direct current stimulation (tDCS) on disability, anxiety and kinesiophobia in athletes with chronic shoulder injury
Public title
The effect of transcranial direct current stimulation (tDCS) on anxiety and kinesiophobia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 18 and 35 years old
Willingness to participate in research
Patients with shoulder joint injury with fear of movement who perform overhead exercises
At least 6 months have passed since the history of musculoskeletal injury
Having the severity of the injury to the extent that the athlete has been away from sports and training for at least two months
Having a score of 37 in the Tampa questionnaire
Not receiving psychological treatment in the past year
Exclusion criteria:
Acute shoulder injury
Having a prosthesis in the skull
Having a cardiac pacemaker
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Using the method of Stratified Permuted Block Randomization with 6 blocks of 6, assignment to two groups is done. In this method, A represents the intervention group and B represents the sham group. In this way, the order of interventions A and B in the form of blocks from number 1 to 6 is determined by the methodological consultant of the project and given to the executive supervisor of the project, and the researcher obtains assignments from the executive supervisor to assign each eligible person.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to reduce the bias in the study, the main researcher will perform all the treatment sessions, and the evaluation sessions before and after the intervention will be done by the research assistant who is a physiotherapist and is blinded to the grouping. The participants in each group will remain unaware of the treatment of the other group, and the evaluator will not be aware of the grouping of people. Therefore, this study is a double-blind study (patients and evaluator).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2022-10-15, 1401/07/23
Ethics committee reference number
IR.SEMUMS.REC.1401.158
Health conditions studied
1
Description of health condition studied
Chronic shoulder injury
ICD-10 code
M75.9
ICD-10 code description
Shoulder lesion, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Before the study, after 2 weeks Intervention, and one month after the end of the study.
Method of measurement
Competitive State Anxiety Inventory-2 (CSAI-2)
Secondary outcomes
1
Description
Disability
Timepoint
Before the study, after 2 weeks Intervention, and one month after the end of the study.
Method of measurement
Disability of Arm, Shoulder and Hand (DASH) questionnaire
2
Description
Kinesiophobia
Timepoint
Before the study, after 2 weeks Intervention, and one month after the end of the study.
Method of measurement
Tampa Scale for Kinesiophobia (TSK) questionnaire
Intervention groups
1
Description
Intervention group: To use the tDCS tool in the intervention group, a direct stimulation current will be used by a pair of electrodes (cathode and anode). A current of 2 mA was applied to the left DLPFC for a maximum of 20 min. The cathode electrode will be used in the right DLPFC. The anode active electrode is placed on the left prefrontal area, corresponding to the F3 point on the international EEG scale of 20-10, and the cathode passive electrode is placed on the right prefrontal area, corresponding to the F4 point on the international scale of -10. 20 EEG is placed. In the intervention group, current electric current is applied
Category
Rehabilitation
2
Description
Control group: In the sham group, the current is first applied for 2 minutes, then the device is turned off.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Amin Mottahedi
Street address
Quds Boulevard, Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 919 374 3200
Email
aminmotahedii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian Far
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3365 4180
Email
aminfar83@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian Far
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3365 4180
Email
aminfar83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian Far
Position
Associate professor
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Semnan Neuromuscular Rehabilitation Research Center
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3365 4180
Email
aminfar83@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD