Determining the effectiveness of Rosvastatin 40 mg compared to placebo on the parameters of electrodiagnostic tests (nerve conduction velocity) of 64 patients with carpal tunnel syndrome who referred to the neuromuscular strip clinic of Bu Ali Hospital, Qazvin University of Medical Sciences in 2014-2014
Design
In this study, the effect of Rosvastatin drug on people with CTS confirmed by electrodiagnostic test with different intensity will be investigated. The drug is evaluated in 40 mg scale.
And also one group is considered as receiving placebo.
64 patients are divided into two groups of rosuvastatin with two doses of 40 mg and placebo based on random allocation.
Settings and conduct
In a three-way blind randomized clinical trial study (patient and study designer), the study population was among people with CTS who referred to the EMG-NCV clinic of Bo Ali Hospital with mild to moderate severity and who had not received any medical or surgical intervention until the time of referral. have not been selected.
Participants/Inclusion and exclusion criteria
People referring to the EMG-NCV clinic of Bo Ali Hospital who have suspected symptoms of carpal tunnel syndrome in terms of clinical symptoms (including pain, paresthesia, and numbness in the area of the median nerve) are initially included in this study as CTS first.
EXCLUDED CRITERIA includes the following:
1- The studied subjects should not be treated with any drug from the statin group.
5- People with cts with severe grade
Intervention groups
this study includes 2 population groups, including people who receive a dose of 40 mg of medicine and people who are treated with placebo.
Main outcome variables
Age/sex/Drug dose/grade cts/Duration of illness/BMI/AMPLITUDE of the median nerve/LATENCY median nerve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231020059773N1
Registration date:2023-12-11, 1402/09/20
Registration timing:prospective
Last update:2023-12-11, 1402/09/20
Update count:0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Farnaz Alidaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 5575
Email address
farnaz.alidae@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-19, 1402/10/29
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of rosuvastatin with dose 40 mg compared to placebo on nerve conduction velocity in64 patients with carpal tunnel syndrome
Public title
Effect of rosuvastatin with dose 40 mg compared to placebo on nerve conduction velocity in64 patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who, in terms of clinical symptoms, have suspicious symptoms related to carpal tunnel syndrome (including pain, paresthesia, and numbness in the area of the median nerve)
People whose CTS is confirmed by electrodiagnostic tests.
Exclusion criteria:
- Subjects should not be treated with any drug from the statin group.
people with hypothyroidism
people with connective tissue diseases
people with rheumatoid arthritis
people with malignancy including Lipoma/ hemangioma
/ people with infectious and inflammatory diseases including sarcoidosis/ septic arthritis
any trauma and local bleeding
hemodialysis/ pregnancy/ any conditions that cause edema and increase in total body fluid
people with cts with grade severe refers to this group in terms of clinical symptoms of people who have hypotrophy and atrophy of the thenar muscle or people who were classified as grade/severe based on electrodiagnostic tests
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
64
More than 1 sample in each individual
Number of samples in each individual:
2
The method of evaluating the effect of the drug on these people is measured by performing NCV and evaluating the median nerve AMPLITUDE/LATENCY. Thus, NCV is collected from patients once before receiving the drug and again 3 months after receiving the drug.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the effect of Rosvastatin drug on people with CTS confirmed by electrodiagnostic test with different intensity will be investigated.
This study includes 2 population groups, including people who receive a dose of 40 mg of medicine and people who are treated with placebo.
The way of selecting people to receive medicine or placebo follows the law of random allocation.
In this way, the total sample size in this study is about 64 people with cts
People are randomly divided into two groups of 32 people (group a to receive medicine / group b to receive placebo)
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding in this study is designed as single blind.
This means that only the participants of this study do not know which group they are in (receiving medicine or placebo).
In this study, the researcher/clinical caregiver/outcome assessor/data analyst and the data safety and integrity committee are aware of the allocation of groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences and Health Services