Comparison of effectiveness of L-carnitine with placebo in improving symptoms, electrodiagnostic study and sonographic parameters in patient with carpal tunnel syndrome
Assessment of L-carnitine effect on carpal tunnel syndrome
Design
In this study, 30 patients with mild to moderate CTS with inclusion criteria, are devided into two groups of 15 randomly; the first group receive oral L-carnitine and second group use placebo
Settings and conduct
This randomized clinical trial that will be conducted on referrals to Physical medicine and rehabilitation clinics of shiraz university of medical science
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18 to 65 years old whose mild or moderate CTS is confirmed by electrodiagnostic study and clinical signe and symptoms
Exclusion criteria: diseases such as diabetes mellitus, hypothyroidism, rheumatic diseases or any diseases that cause neuropathy
Patients who use chemotherapy drugs or any drug that cause neuropathy
Pregnant or breast feeding women, body mass index >40 and <18
History of seizure, drug allergy or uncontrolled blood pressure
Intervention groups
First group received L-carnitine
Second group received placebo
Main outcome variables
electrodiagnostic and sonograghic parameters of median nerve at wrist, pain and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046711N1
Registration date:2020-04-01, 1399/01/13
Registration timing:retrospective
Last update:2020-04-01, 1399/01/13
Update count:0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Narges Nikpay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9040
Email address
n_nikpay@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
2019-05-15, 1398/02/25
Actual recruitment end date
2020-03-02, 1398/12/12
Trial completion date
2020-05-14, 1399/02/25
Scientific title
Comparison of effectiveness of L-carnitine with placebo in improving symptoms, electrodiagnostic study and sonographic parameters in patient with carpal tunnel syndrome
Public title
Effect of L-carnitine in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parsons who there CTS is confirmed by electrodiagnostic study and clinical signe and symptoms
Patients who aged 18 to 65 years old
Exclusion criteria:
Diseases such as diabetes mellitus, hypothyroidism, rheumatologic diseases, end stage renal disease
Patients who use chemotherapy drugs or any drug that cause neuropathy
Pregnant or breast feeding women
History of seizure
Bon mass index > 40 or <18
History of drug allergy
Uncontrolled blood pressure
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: with regard to the numbers of treatment groups (2 groups), we considered blocks with size of four, the first group is shown with A and second with B, then determines formation of persons in groups by using random allocation software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of shiraz university of medical sciences
Street address
Fars province, shiraz, zand
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸-۱۴۳۳۶
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.SUMS.MED.REC.1398.109
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
electrodiagnostic parameters
Timepoint
Before intervention, 4 then 6 weeks after onset
Method of measurement
Electrodiagnostic instruments
2
Description
Hand pain and function
Timepoint
before intervention, 4 then 6 weeks after onset
Method of measurement
Boston questioner
3
Description
cross sectional area of median nerve at wrist
Timepoint
Before intervention, 4 then 6 weeks after onset
Method of measurement
Sonography instrument
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: received L-carnitine، coren company, 500 mg twice per day for 6 weeks, combination of metionin and lysine amino acid,
Category
Treatment - Drugs
2
Description
Intervention group: received placebo, that is made by Dr.Zare pharmacy and containing starch capsules
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Physical medicine and rehabilitation of shiraz university of medical science
Full name of responsible person
Alireza Ashraf
Street address
Zand street , Shiraz town
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3231 9040
Fax
+98 71 3235 9317
Email
N_nikpay@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir hashemi
Street address
Zand street, shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3235 9317
Email
N_nikpay@sums.ac.ir
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
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Nikpay
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 3 , Abiverdi 3, chamran Blvd, shiraz, fars
City
Shiraz
Province
Fars
Postal code
7194765748
Phone
+98 71 3231 9040
Email
N_Nilpay@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Nikpay
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 3 , Abiverdi 3, chamran Blvd, shiraz, fars
City
Shiraz
Province
Fars
Postal code
7194765748
Phone
+98 71 3231 9040
Email
N_nikpay@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Nikpay
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No . 3, Abiverdi 3, chamran Blvd, shiraz
City
Shiraz
Province
Fars
Postal code
7194765748
Phone
+98 71 3231 9040
Email
N_Nikpay@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available