Objective:
The main aim of this study is to compare the effectiveness of steroid injection and wrist splint in severe carpal tunnel syndrome (CTS) in pregnancy.
Design:
This study is a randomized clinical trial which will be accomplished from October 2012 to June 2013 at Shahid (S) Mofateh clinic on 70 pregnant women. The cases selected by blocked randomization among pregnant women who referred to obstetrics and gynecology clinic in Yasuj city in south- west of Iran.
Setting and Conduct:
Pregnant women that have symptoms (pain and paresthesia of fingers) and signs of CTS, such as positive Tinel and/or Phalen tests, refer to physiatrist for performing standard electrodiagnostic studies.
Electrophysiologic parameters of median and ulnar nerves recorded before start of intervention.
If there is severe CTS, the patients randomly classified in two groups.
The first group receives 40 milligram(mg) triamcinolone acetonide (Triamhexal,40 mg/1 milliliter(ml), made by Holzkirchen factory ,Germany) intraarticular in carpal tunnel of involved wrist by physiatrist.The second group wears wrist splint that was product of Iran Odor Company for 8 weeks in nights .
The patients evaluated by clinical and electrodiagnostic studies after 2 months from starting the intervention.
In cases of observing changes from severe to lower stages of the disease in electrodiagnostic studies, treatment was considered successful and otherwise failed.
Participants:
Main inclusion criterion includes paresthesia of fingers that begin in pregnancy in ages between 15 and 49 years old y/o.
Major exclusion criterion includes pre-pregnancy paresthesia of fingers and underlying disease such as diabetes mellitus.
Intervention:
The first group injected 40 mg of triamcinolone (intraarticular) in carpal tunnel of involved wrist.
The second group received wrist splint that wear in nights for 8 weeks.
Main outcome:
Main outcomes includes detection of symptoms (pain and paresthesia of fingers) and severity of CTS in electrodiagnostic studies.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012110210799N3
Registration date:2013-02-12, 1391/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-12, 1391/11/24
Registrant information
Name
Parviz Yazdanpanah
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 1005
Email address
yazdanpanah.p@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2012-11-30, 1391/09/10
Expected recruitment end date
2013-05-30, 1392/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of triamcinolone and wrist splint in severe carpal tunnel syndrome in Pregnancy
Public title
Efficacy of steroid injection and wrist splint in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria includes women that had paresthesia of hands during pregnancy(pregnancy related carpal tunnel syndrome) and ages between 15 and 49 y/o).
Exclusion criteria in this study are diabetes mellitus, collagen vascular disease, renal failure, hypothyroidism, rheumatoid disease, pre-pregnancy carpal tunnel syndrome, positive family history of neuropathy, carpal tunnel surgery and fracture of wrist bones.
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
S.Motaheri street,Site of University
City
Yasuj
Postal code
7591741417
Approval date
2012-02-20, 1390/12/01
Ethics committee reference number
6/10/12/90/پ
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56
ICD-10 code description
Mononeuropathies of upper limb,Carpal tunnel syndrome
Primary outcomes
1
Description
Severity of pregnancy related CTS
Timepoint
In start of study and 2 months after intervention
Method of measurement
Clinical examination and electrodiagnostic studies
Secondary outcomes
1
Description
Pain and numbness of fingers
Timepoint
Before and 2 months after treatment intervention
Method of measurement
Visual analogue scale and electrodiagnostic studies
Intervention groups
1
Description
The second group wear wrist splint(product of Iran Odor company) for 8 weeks during nights.
Category
Treatment - Devices
2
Description
The first group receive 40 mg triamcinolone Acetonide(Triamhexal 40,1 mg crystalline suspension,intraarticular,manufactured of Holzkirchen factory in Germany)in involved wrist of severe CTS.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid(S).Mofateh Clinic of Yasuj
Full name of responsible person
Hossin Rahimipour
Street address
S.Jalil street,Medical College
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Doctor(Dr) Mohamad Akbartabar
Street address
S.Motahari street,Site of University
City
Yasuj
Grant name
بودجه های پژوهشی دانشگاه
Grant code / Reference number
124013
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Hosin Rahimipour
Position
Medical Student
Other areas of specialty/work
Street address
S.Jalil street,Medical college
City
Yasuj
Postal code
7591741417
Phone
+98 74 1223 1005
Fax
+98 74 1223 1005
Email
-
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Parviz Yazdanpanah
Position
Physiatrist
Other areas of specialty/work
Street address
S.Jalil street,Medical college
City
Yasuj
Postal code
7591741417
Phone
+98 74 1223 1005
Fax
+98 74 1223 1005
Email
yazdanpanah.p@yums.ac.ir;parvan1339@yahoo.com
Web page address
www.yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Parviz Yazdanpanah
Position
Physiatrist
Other areas of specialty/work
Street address
S.Montazeri street,S.Mofateh clinic
City
Yasuj
Postal code
7591794856
Phone
+98 74122282121
Fax
+98 74 1223 1005
Email
yazdanpanah.p@yums.ac.ir;parvan1339@yahoo.com
Web page address
www.yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)