Carpal Tunnel Syndrome (CTS) is the most common mediastinal neuropathy that is caused by the pressure of the median nerve under the transverse wrist ligament. In this study, we investigated the effect of rosuvastatin on clinical signs and electrodeaganoid findings in patients with mild to moderate CTS. The present study is an interventional study (RCT). The study population included all patients with mild to moderate degrees of CTS. From among the patients referring to the study, 50 subjects were selected by available sampling and randomly assigned 25 patients in the treatment group with resoastatin and 25 in the control group (gol drug treatment). The study is done blindly. According to the random numbers table, they are divided into test and control groups. We will give Rosvothactine to one of the groups and another drug group. After taking the biography and conducting the examination, according to the findings of electrodeagnosis, they are in the mild and moderate group. The division of patients into these two groups according to the degree of median nerve function disorder is based on the findings of electrodeagnosis of the nerve damage. In the test group, a dose of 20 mg once daily is given as a rosuvastatin tablet and a daily dose of one tablet of placebo for one month. Data were collected using Boston Questionnaire, Visual Analogue Benchmarking (VAS), and Electrodiogenic Findings (EDX). Patients with clinical signs and electrodiagnostic CTS with mild to moderate intensity entered the study and patients who had previous history of statin use, history of previous surgery for CTS, severe CTS patients with muscle atrophy, severe statin allergy out of study To be
The effect of Rosuvastatin on clinical and electrodiagnostic findings in patients with Carpal Tunnel Syndrome
Public title
The effect of Rosuvastatin on Carpal tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:
Patients with mild to moderate clinical symptoms and electrodiagnostic features of CTS.
Exclusion criteria: patients who have a history of taking statins; history of previous surgery for CTS; patients with severe CTS with muscle atrophy; extreme sensitivity to statins.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Postal code
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.16
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome (CTS)
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
median nerve motor and sensory distal latency
Timepoint
1 month(interval between the onset of treatment determines the outcome of the study)
Method of measurement
nerve conduction study
2
Description
Symptom severity and functional status of the patient
Timepoint
1 month
Method of measurement
According to Boston Questionnaire
3
Description
severity of pain
Timepoint
1 month
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Patients' function
Timepoint
1
Method of measurement
Boston Questionnaire
Intervention groups
1
Description
In the intervention group, rosuvastatin 20 mg once daily.
Category
Treatment - Drugs
2
Description
A daily control group is prescribed a placebo tablet for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Mehdi Karimian
Street address
Nemazee square, shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadegh Fard
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadegh Fard
Position
Assisstant Professor of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Motahari Clinic, Namaz Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1572
Fax
Email
poursadegh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadegh Fard
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Clinic, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1572
Fax
Email
poursadegh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical Neurology Research Center, Shiraz University of Medical Sciences Shiraz Iran
Full name of responsible person
Mojtaba Neydavoodi
Position
Research Expert
Other areas of specialty/work
Street address
Khalili Street, Mohammad Rasool Allah Research Tower
City
Shiraz
Postal code
Phone
+98 71 3628 1572
Fax
Email
neydavodi41@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)