Assessment of the effect of stretching and resistance training protocol on the consequences of carpal tunnel syndrome.
Determining the average score of Boston Questionnaire symptoms in both groups before and after the intervention
Determining the average score of Boston Questionnaire functions in both groups before and after the intervention
Determining the average total score of Boston Questionnaire in both groups before and after the intervention
Determining the average score of Boston Questionnaire symptoms in both groups before the intervention
Determining the average score of Boston Questionnaire symptoms in both groups after the intervention
Determining the average score of Boston Questionnaire functions in both groups before the intervention
Determining the average score of Boston Questionnaire functions in both groups after the intervention
Determining the average total score of Boston Questionnaire in both groups before the intervention
Determining the average total score of Boston Questionnaire in both groups after the intervention
Design
Randomized trial ,control group with blocks of 4
Settings and conduct
All patients with CTS referred to Imam Hossein hospital
Participants/Inclusion and exclusion criteria
Written and informed consent from the individual
Age 18-70
Definitive diagnosis of CTS based on symptom
Not having inflammatory and autoimmune disease
Not having muscle atrophy
Not having severe CTS
No history of corticosteroid use
Intervention groups
Effect of stretch and strength exercise on improvement of CTS
Main outcome variables
prevention of surgery , invasive treatment in patients with CTS
General information
Reason for update
Acronym
CTS
IRCT registration information
IRCT registration number:IRCT20220829055819N1
Registration date:2022-09-24, 1401/07/02
Registration timing:registered_while_recruiting
Last update:2022-09-24, 1401/07/02
Update count:0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Katayoun Mirmahdian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 9409
Email address
katayoun_mir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of stretching and resistance training protocol on the consequences of carpal tunnel syndrome.
Public title
Effect of stretch and strength exercise on carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written and informed consent from the individual
Age 18-70
Definitive diagnosis of CTS based on symptoms
Exclusion criteria:
Not having inflammatory and autoimmune disease
Not having muscle atrophy
Not having severe CTS
No history of corticosteroid use
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
1
One hand or 2hands with CTS
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be included in the study based on the inclusion criteria, after obtaining informed consent, using the block randomization method, using the following 4 blocks, they will be divided into two groups: standard treatment group A and intervention group B.
1. AABB
2. ABAB
3. BBAA
4. BABA
5. BAAB
6. ABBA
Using a random number table, one of the indexes 1 to 6 is selected, and the patients are placed in one of the groups A or B based on the selected blocks. Again, using a random number table, one of the numbers 1 to 6 is selected, and the patients are selected according to the same treatment block, A or B, and this process continues to obtain 70 patients. It is expected that 18 blocks will be selected randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No.15,East 32 Ave , Farjam Blvd, Resalat Square
City
Tehran
Province
Tehran
Postal code
1676934411
Approval date
2022-07-25, 1401/05/03
Ethics committee reference number
IR.SBMU.MSP.REC.1401.197
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hand strength
Timepoint
The beginning of the study , Monthly
Method of measurement
Hand grip , Pinch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Stretch and Strength exercises
Category
Rehabilitation
2
Description
Control group: Using of appropriate and night splint for CTS
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Katayoun Mirmahdian
Street address
No.1,East 32 Ave , Farjam Ave , Resalat Square
City
Tehran
Province
Tehran
Postal code
1676934411
Phone
+98 21 7722 8534
Email
Katayoun_mir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoun Mirmahdian
Street address
No15,East 32 Ava.,Farjam Aven.,Resalat Square
City
Tehran
Province
Tehran
Postal code
1676934411
Phone
+98 21 7734 2285
Email
katayoun_mir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahin Salehi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8670 5503
Email
salehi2955@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoun Mirmahdian
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Narmak
City
Tehran
Province
Tehran
Postal code
1667934411
Phone
+98 21 7722 8534
Fax
Email
Katayoun_mir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Katayoun Mirmahdian
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
No15,East32 Ave,Farjam Ave,Resalat Squre
City
Tehran
Province
Tehran
Postal code
1676934411
Phone
+98 21 7722 8534
Fax
Email
Katayoun_mir@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data of people can be shared after de-identifying them
When the data will become available and for how long
1402
To whom data/document is available
Sport medicine , neurologists
Under which criteria data/document could be used
for using in the future studies , in retrospective studies
From where data/document is obtainable
Katayoun Mirmahdian
Phone number 09128253650
What processes are involved for a request to access data/document
Call to Katayoun Mirmahdian ,Data access in the first half of 1402