Our clinical trial is to evaluate the effectiveness of long term using of splinting in comparrison with short term usage of splinting in severe CTS in pt who do not accept surgical treatment.
Research purposes:our purpose is to study the long term use of splint in carpal tunnel syndrome patients that rejected surgery therapy.
Planing:it is an interventional study.
Methodology:sample size:140 persons.The patients are randomly placed in two groups.One group receives the splint for six weeks and the other for six months.Both groups receives standard medical treatment (including NSAID and vitamin B6) in the same way.
All the patients are investigated at the beginning and the end of the sixth week and the end of sixth month to examine the consequences.
Inclusion criteria: patient with severe CTS that did not accept surgical treatment. Exclusion criteria :patient with previous surgery on the study hand or wrist; any mass; tumor; or deformity in the hand or wrist; any history of severe trauma to the wrist (such as fracture); polyneuropathy; cervical radiculopathy; pregnancy; or lactating ; fibromyalgia; and arthritis.
Interventions :prescribing splint in a group for six weeks and six months for the other.
The variables of the main consequences: development in electrodiagnostic parameters and Boston questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091814704N1
Registration date:2015-05-17, 1394/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Shahrzad Sanaee
Name of organization / entity
Shiraz University of Medical Sciences(SUMS)
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 1087
Email address
sanaeesh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Shiraz University of Medical Science
Expected recruitment start date
2012-12-28, 1391/10/08
Expected recruitment end date
2013-04-24, 1392/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Our clinical trial is to evaluate the effectiveness of long term using of splinting in comparrison with short term usage of splinting in severe CTS in pt who do not accept surgical treatment.
Public title
Effectiveness of long time using of splinting in severe CTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with severe cts that did not accept surgical treatment Exclusion criteria:patient with previous surgery on the study hand or wrist; any mass; tumor; or deformity in the hand or wrist; any history of severe trauma to the wrist (such as fracture); polyneuropathy; cervical radiculopathy; pregnancy; or lactating; fibromyalgia; arthritis
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
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 shiraz universty of medical science
Street address
3rd floor, managment building of shiraz university of medical sciences, Zand Avenue.
City
Shiraz
Postal code
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
CT-2014-224
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
EMG and NCV are the primary outcomes measurements that at the end they determinate the efficacy of the splint for the study
Timepoint
at the begining and at the end
Method of measurement
CTSAQ,Boston questionaire
Secondary outcomes
1
Description
clinical manifestations
Timepoint
every 2 weeks
Method of measurement
physical exam
Intervention groups
1
Description
The intervention group will receive (naproxene 500mg 3times a day) for 10 days and vit B1 B6 tabs for 6month.They use splint for 6 months
Category
Rehabilitation
2
Description
The control group:The patients use splint for 6 weeks.They will receive (naproxene 3 times a day) for 10 days and Vit B1 B6 for 6 months .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical medicine and Rehabilitation clinics of Fghihi hospital
Full name of responsible person
Dr.Sharareh Roshanzamir
Street address
Faghihi hospita ,Zand Avenue ,Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Shiraz University of Medical Science
Full name of responsible person
Dr.Postfrosh
Street address
Platform 7 , management building of Shiraz University of medical science ,Zand Avenue ,shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research ,Shiraz University of Medical Science
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
International branch of Shiraz University of Medical Science
Full name of responsible person
Shahrzad Sanaee
Position
Intern
Other areas of specialty/work
Street address
Door plate:71, Street number 1, Jahad Sazandegi Avenue, Azadi plaza, Shiraz
City
Shiraz
Postal code
7144716699
Phone
+98 71 3227 4250
Fax
Email
shahrzad.sanaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Sharareh Roshanzamir
Position
Assistant professor of Rehabilitation and physical medicine
Other areas of specialty/work
Street address
Physical medicne and Rehabilitation ward's off, second floor, Faghihi Hospital, Zand Avenue, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3235 1087
Fax
Email
sharareh.roshanzamir@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Shahrzad Sanaee
Position
Intern
Other areas of specialty/work
Street address
Door plate 89,street number 88,Ghasrodasht Avenue,Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
shahrzad.sanaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)