Protocol summary

Study aim
Determining of the effect of stretching of wrist and finger flexors on carpal tunnel syndrome in comparison to physiotherapy
Design
In this research, 62 cts patients that diagnosed by rehab sub specialist were chosen purposefully and a code was allocated to each one of them.then, patients were randomly divided into two  control and intervention groups.
Settings and conduct
Unidirectional blindness choosen patient in rehabilitation clinics of shiraz university of medical siences
Participants/Inclusion and exclusion criteria
Inclusion criteria is all the patient with mild to moderate cts Exclusion criteria is all thepatient with methabolic disease like diabete and hypothroiid and pregnancy
Intervention groups
Intervention group consist 31 patient with cts that do streching and the control group consist 31 patient with cts that do physiotherapy
Main outcome variables
For choosing the best, the more comfortable, low costs and less side effect for patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170927036455N1
Registration date: 2018-01-15, 1396/10/25
Registration timing: registered_while_recruiting

Last update: 2018-01-15, 1396/10/25
Update count: 0
Registration date
2018-01-15, 1396/10/25
Registrant information
Name
Mehrdad Dabiri
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
*
Email address
dabirym@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Thesis plan of shiraz univercity of medical science
Expected recruitment start date
2017-10-15, 1396/07/23
Expected recruitment end date
2018-04-12, 1397/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of stretching of wrist and finger flexors on carpal tunnel syndrome in comparison to physiotherapy
Public title
Investigation of the effect of stretching of wrist and finger flexors on carpal tunnel syndrome in comparison to Acupuncture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patient with mild to moderate cts that Diagnosed by subspecialist that dont have methabolic diseases like diabete and hypothyroiid and pregnancy All the patient with cts between age 25 to 55 years
Exclusion criteria:
Hypothyroidism Diabetes Pregnancy Lactation History of truma or surgery on wrist Pripheral Radiculopathy or neuropathy( except tunnle carp syndrome)
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization in the form of 4th blocks in the form of aabb without to consider time or place or sex
Blinding (investigator's opinion)
Single blinded
Blinding description
Primary questionnaire and NCV of patients done by one of the plan partner that had no information about discription of patients on two groups then block randomization done by one of the anchors of the plan that have no information about the questionnaire and result of ncv. Then patient will evaluate by the plan partner that done primary ncv and questionnaire( plan partner have no information about interventional group) Interventional group defined by code 1 & 2 and estatistic analyzer had no information about interventional group too. So estatistic analyzer and Researcher evaluator have become blindness
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Univercity of Medical Science
Street address
Rehab Clinic of Shiraz University of Medical Science, Second floor, Shahid Faghihi Hospital, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
Ir.sums.med.rec.1396.s78

Health conditions studied

1

Description of health condition studied
Carpal tunnel syndrom
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb

Primary outcomes

1

Description
Nerve conduction improvment
Timepoint
Before intervention, after intevention , 3month after intervention
Method of measurement
Nerve conduction velocity

Secondary outcomes

1

Description
Decreaa in symptomes amd improvement of performance
Timepoint
Before intervention, after intervention, 3month after intervention
Method of measurement
Boston questioner

Intervention groups

1

Description
Interventional group : estretching exercise : including 4 types of exercise that done every day about 3months and each day shod done 4 times thats about 20 seconds duration.1.the patient extend one hand to front and pull his finger with another hand that shod be estretch flexors muscles.2the patient should put his palmar surface on a desk and extend his elbow then should a little forward bending to estretch on flexors muscles.3.the patient should to stick palmar surfaces of both hand together and keep theme anterior of chest then push down to estrech on flexor muscles
Category
Rehabilitation

2

Description
Control group: physiotherapy,(TENS, US Under water, Gliding masage, Grip exercise) in 10 times that each one about 1 hour and 3session on a week
Category
Other

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 Clinic of Shiraz Univercity Of Medical Science, Second floor, Shahid Faghihi Hospital, Zand street , Shiraz
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 9040
Email
Sharareh.roshanzamir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Fateme Zare
Street address
Marvdasht
City
Marvdasht
Province
Fars
Postal code
7134844119
Phone
+98 71 3231 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 Science
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
Mehrdad Dabiry
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Medical student
Street address
First floor, Reyhane apartment, Kherad street, Arian township, Shiraz
City
Shiraz
Province
Fars
Postal code
7197683398
Phone
+98 71 3654 3633
Fax
Email
Mehrdad.neverhood@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Rehabilitation Specialist
Latest degree
Specialist
Other areas of specialty/work
Rehabilitation management
Street address
Third floor, Imamreza clinic, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3231 9040
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
Sara Sarikhani
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Medical student
Street address
No. 24, Second floor, Narvan street, Shiraz
City
Shiraz
Province
Fars
Postal code
7144757559
Phone
+98 71 3229 3724
Fax
Email
Sara.sarikhani69@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 which dose not include the following items.if the jornals edditor requiers the items mentiond, it will be provided to him/her.and the way of publication will be according to the opinion of the journal's edditor
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
No - There is not a plan to make this available
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