Protocol summary

Study aim
Determining of the effect of stretching of wrist and finger flexors on carpal tunnel syndrome in comparison to corticosteroid injection
Design
In this research, 62 cts patients whom diagnosed by rehab subspationlisy were chosen purposefully and code was allocated to each one of them, then, patient were randomly divided into two control and intervention groups.
Settings and conduct
Unidirectional blinded patient in rehabilitation clinics of shiraz university of medical sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:all the patient with mild to moderate CTS Exclusion criteria:all the patient with metabolic disease, diabetes,hypothyroid and pregnancy
Intervention groups
thirty one patients with mild to moderate CTS treated with stretching of wrist and finger flexors and 31 Patients with mild to moderate CTS treatet with corticosteroid injection and then two groups compare with each other
Main outcome variables
In this research effects of stretching of wrist and finger flexors compare with corticosteroid injection in carpal tunnel syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170927036456N2
Registration date: 2018-06-19, 1397/03/29
Registration timing: retrospective

Last update: 2018-06-19, 1397/03/29
Update count: 0
Registration date
2018-06-19, 1397/03/29
Registrant information
Name
Arash Saharkhiz
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 257 9670
Email address
saharkhiza@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Thesis plan of Shiraz university of medical sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
Investigation of the effect of stretching on wrist and fingers flexors on carpal tunnel syndrome in comparison with corticosteroid injection.
Public title
Investigation of the effect of stretching on wrist and fingers flexors on carpal tunnel syndrome in comparison to corticosteroid injection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with mild to moderate cts All patients with cts between age 25 to 55
Exclusion criteria:
Hypothyroidism Diabetes Pregnancy Lactation History of truma or surgery on wrist Pripheral radiculopathy or neuropathy ( except carpal tunnel sydrome )
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 62
Actual sample size reached: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization in the form of 4th block
Blinding (investigator's opinion)
Single blinded
Blinding description
The person responsibe for completing the questionnaires, data collection and data analysis
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of shiraz univercity of medical science
Street address
Rehab clinics of shiraz univercity of medical science, shiraz city, zand street, shahid faghihi hospital,second floor
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
Ir.sums.med.rec.1396.46

Health conditions studied

1

Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome

Primary outcomes

1

Description
nerve conduction improvement
Timepoint
Before intervention/after intervention/3 month after intervention
Method of measurement
Nerve conduction velocity

Secondary outcomes

1

Description
Decrease in symptoms and improvement of performance
Timepoint
Before intervention/after intervention/3months after intervention
Method of measurement
Boston questionnair

Intervention groups

1

Description
Interventional group::corticosteroid injection
Category
Rehabilitation

2

Description
Control group: stretching of wrist and finger flexors
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation clinics of Shiraz university of medical sciences
Full name of responsible person
Sharareh roshanzamir
Street address
Rehab clinics of shiraz univercity of medical science, shiraz city, zand street, shahid faghihi hospital,second floor
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3323 9040
Email
Sharareh.roshanzamir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme zare
Street address
Shiraz university of medical sciences
City
Marvdasht
Province
Fars
Postal code
7134844119
Phone
+98 71 3323 9040
Email
Sharareh.roshanzamir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Specialist of rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Third floor, emam reza clinic, flake namazi, zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3323 9040
Fax
Email
Sharareh.roshanzamir@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr sharareh roshanzamir
Position
Rehabilitation especialist
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
third floor, emam reza clinic, namazi sq,zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 917 711 1359
Fax
Email
Sharareh.roshanzamir@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Specialist of rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Third floor emam reza clinic,namazi sq,zand street,shiraz
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3323 9040
Fax
Email
Sharareh.roshanzamir@gmail.com
Web page address

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
With the complation of this project in 1396 witch dosent include the following items. If the journal edditors requires the items mentioned, it will be provided to him/ her. And the way of publication will be according to the opinion of the journal’s editor.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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