(1) Objective: The aim of this study is to review Effect of extract of Stoechas Lamiaceae on mild and moderate carpal tunnel syndrome.
(2) Design: In this study, 60 patients with mild to moderate carpal tunnel syndrome which their disease was confirmed by physical medicine and rehabilitation specialist will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: Patients will be randomly divided to groups of thirty. For randomization we will use computerized randomization with Excel software. Inclusion criterion is clinical and electrodiagnostic demonstration of mild to moderate carpal tunnel syndrome. Exclusion criteria are clinical and electrodiagnostic severe carpal tunnel syndrome, history of trauma or fracture of the wrist, history of surgical release of nerve, signs of cervical radiculopathy in C6 - C7, systemic diseases such as neuropathies, rheumatoid arthritis, hypothyroidism, diabetes mellitus and renal failure.
(4) Interventions: In intervention group wrist splint and stoechas lamiaceae extract two times a day will be administered for four weeks. On the other hand in control group wrist splint and placebo will be administered for four weeks.Patients in both groups will receive 25 mg Diclufenac tablet two times a day. They also will be advised to avoid doing severe activities with their hand. (5) Main outcome measures: Boston questionnaire score, hand forces and EMG-NCV findings will be evaluated before initiating the protocol and after finalizing the study at the end of the third week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502244641N10
Registration date:2015-08-23, 1394/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-23, 1394/06/01
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical medicine and rehabilitation researches center
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate effect of extract of Stoechas Lamiaceae in EMG-NCV criteria of patients with mild to moderate carpal tunnel syndrome
Public title
Effect of extract of Stoechas Lamiaceae on mild and moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Cinical and electrodiagnostic demonstration of mild to moderate carpal tunnel syndrome. Exclusion criteria: Clinical and electrodiagnostic severe carpal tunnel syndrome; history of trauma or fracture of the wrist; history of surgical release of nerve; signs of cervical radiculopathy in C6 - C7; systemic diseases such as neuropathies, rheumatoid arthritis, hypothyroidism, diabetes mellitus and renal failure; collagen vascular diseases; skin allergies; age<15 and age>60
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Ethics committee, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
91167
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-NCV criteria
Timepoint
Before study and after it
Method of measurement
By using EMG-NCV device
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group wrist splint and stoechas lamiaceae extract two times a day will be administered for four weeks.
Category
Treatment - Drugs
2
Description
In control group wrist splint and placebo will be administered for four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Dr. Bina Eftekharsadat
Street address
Department of Physical Medicine and rehabilitation, Shohada hospital, Gholshahr, El Gholi street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical medicine and rehabilitation researches center
Full name of responsible person
Dr. Vahideh Toopchizade
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical medicine and rehabilitation researches center
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
Tabriz University of Medical Sciences
Full name of responsible person
Shervin Torabi
Position
Medicine student
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
sh.torabi1990@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
binasadat@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor of Physical Medicine & rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)