Determining of the effect of stretching of wrist and finger flexors on carpal tunnel syndrome in comparison to acupanture
Design
In this researche, 62 patients with mild to moderate carpal tunnel syndrome that diagnose by rehab specialist are choosen and patients are randomly divided into two control and intervdntion groups that allocate a code to each one.
Settings and conduct
Single blind ( 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)
patient in rehabilitation clinics of shiraz university of medical sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:
all the patients with mild to moderate carpal tunnel syndrome
Age between 25 to 55 years old
Exclusion criteria:
Hypothyroidism
Diabetes
Pregnancy
Lactation
History of truma or surgury on wrist
Peripheral radiculopathy or neuropathy( except carpal tunnel syndrome )
Intervention groups
Intervention group consiste 31 patients with cts that do streching and the control group consits 31 patients with cts that do acupunture
Main outcome variables
For choosing the best , more comfortable ,low costs and less side effect for patients with carpal tunnel syndrom on function , symptome , nerve concuction velocity and compound muscle action potential.
Primary outcome variable: Boston questionnaire of Signs and function of patients
Secondary outcome variable: nerve conduction velocity (ncv) and (cmap)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170927036457N2
Registration date:2018-01-29, 1396/11/09
Registration timing:registered_while_recruiting
Last update:2018-01-29, 1396/11/09
Update count:0
Registration date
2018-01-29, 1396/11/09
Registrant information
Name
Sara Sarikhani
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 938 887 9917
Email address
sarikhanys@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Thesis plan of shiraz univercity of medical science c
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 Acupuncture
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:
The patient with mild to moderate carpal tunnel syndrom
Age between 25 to 55
Exclusion criteria:
Hypothyroidism
Diabetes
Pregnancy
Lactation
History of truma or surgery on wrist
Peripheral radiculopathy or neuropathy ( except carpal tunnle syndrome)
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
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 committe of shiraz university of medical science
Street address
Rehab clinc of shiraz univercity of medical scince, shiraz city , zand street, shahid faghihi hospital, second floor
City
SHIRAZ
Province
Fars
Postal code
7134844119
Approval date
1997-09-23, 1376/07/01
Ethics committee reference number
Ir.sums.med.rec.1396.45
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
Description
Nerve conduction improvement
Timepoint
Before intervention-after intervention-3 months after intervention
Method of measurement
Nerve conduction velocity
Secondary outcomes
1
Description
Decrease in symptoms of patients & improve of performance
Timepoint
Before intervention-after intervention-3 months 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: acupuncture including 10 sessiona that that each one about 30 minute and 3 sessions on a week
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation clinics of shiraz university of medical science
Full name of responsible person
Sharare roshanzamir
Street address
Rehab clinc of shiraz university of medical sience of shiraz, 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?
First floor, rihane apartemant,kherad street, arian township,shiraz
City
Shiraz
Province
Fars
Postal code
7197683398
Phone
+7 136543633
Fax
Email
Mehrdad.neverhood@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 editor