Investigation of the Effect of Vitamin B6 Supplement in Comparison to L-acetyl-carnitine on Improvement of Patients with Carpal Tunnel Syndrome
Design
Two arm parallel group randomized clinical trial with blinded outcome assessment enrolled 60 patients. Randomization is centralized and computerized with block permutation and random allocation software respectively.
Settings and conduct
Patients with mild to moderate symptoms of carpal tunnel syndrome that is proven in electrodiagnostic studies, divided in 2 groups. One group will received 120 mg Vitamin B6 daily and the other group received 1500 mg L-acetyl-carnitin. Both group will received their supplements with splint for 10 weeks. Patients will assessed before beginning the treatment, 10 and 18 weeks later with electrodiagnostic study and 2 specific questionnaires (Visual Analog Scale and Boston Carpal Tunnel Questionnaire).
In this study person who fulfills the questionnaires and analyzer are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mild to moderate carpal tunnel syndrome that confirmed with electrodiagnostic study within last 2 months in patients with age between 30 to 60.
Exclusion criteria: severe carpal tunnel syndrome, muscle atrophy, history of surgery,injection or trauma, history of systemic disease.
Intervention groups
One group received 120 mg Vitamin B6 per day and other group received 1500 mg L-acetyl-carnitine for 10 weeks
Main outcome variables
Evaluation of Median sensory nerve action potential (SNAP) in electrodiagnostic studies before and after treatment; Assessment of scores of the questionnaires before and after treatment
General information
Reason for update
Acronym
CTS
IRCT registration information
IRCT registration number:IRCT20210915052494N1
Registration date:2021-11-04, 1400/08/13
Registration timing:prospective
Last update:2021-11-04, 1400/08/13
Update count:0
Registration date
2021-11-04, 1400/08/13
Registrant information
Name
Navid Parsa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 1961
Email address
dr.parsanavid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of Vitamin B6 Supplement in Comparison to L-acetyl-carnitine on Improvement of Patients with Carpal Tunnel Syndrome
Public title
Effect of Vitamin B6 and L-acetyl-carnitin in Treatment of Carpal Tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Mild or Moderate Carpal Tunnel Syndrome
Disease Proved with Electrodiagnostic Study within Last 2 Months
Patients Age Ranges from 30-60
Exclusion criteria:
Severe Carpal Tunnel Syndrome
Muscle Atrophy
History of Carpal Tunnel Syndrome surgery
History of Trauma
History of Fracture
History of Direct Injection of Carpal Tunnel
History of Recent Usage of Corticosteroids and Analgesics
Diabetes
Collagen Vascular Disorders
Rheumatologic Disorders
Active Radiculopathy
Past Medical History of Brucellosis
Pregnancy
Lactation
Alcoholism
Nerve Injury
Neuropathy
Inability in Communication and Fulfilling Questioners
History of Allergic Reaction to Studied Medications
History of Significant Liver, Kidney or Cardiovascular Disease
Cancer
History of Injection Around Wrist within 3 Last Months
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block permutation with 4 samples in each block will be used. 2 final lists with using random allocation software will be made. For allocation concealment, randomized sequence is given to an uninformed person (etc; clinic secretary)
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who fills the questionnaires and static analyzer are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Physical medicine and rehabilitation Department, Faghihi hospital, Zand Blvd
City
Shiraz
Province
Fars
Postal code
713484411
Approval date
2021-06-14, 1400/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1400.212
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Latency of Median sensory nerve action potential
Timepoint
Before the treatment, 10 and 18 weeks after beginning treatment
Method of measurement
Electromyography-Nerve conduction study (EMG-NCV) machine
2
Description
Score of clinical symptoms (like pain and paresthesia) in questionnaires
Timepoint
Before the treatment, 10 and 18 weeks after beginning treatment
Method of measurement
Visual Analogous Scale and Boston Carpal Tunnel Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: 120 mg Vitamin B6 Janilous pharmaceutical Co. daily and splint for 10 weeks
Category
Treatment - Drugs
2
Description
Second intervention group: 1500 mg L-acetyl-carnitine Dana pharmaceutical Co. daily and splint for 10 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi hospital
Full name of responsible person
Navid Parsa
Street address
Faghihi hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
7113484411
Phone
+98 71 3231 9040
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaian Zade
Street address
Research department, Shiraz University of Medical Science, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7113484411
Phone
+98 71 3212 2686
Email
researchethic@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
100
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
Navid Parsa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 50, Golestan 4th alley, Nahid Ave, Marzdaran
City
Tehran
Province
Tehran
Postal code
1461643744
Phone
+98 21 2201 9258
Email
dr.parsanavid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Navid Parsa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 50, Golestan 4th alley, Nahid Ave, Marzdaran
City
Tehran
Province
Tehran
Postal code
1461643744
Phone
+98 21 2201 9258
Email
dr.parsanavid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Navid Parsa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 50, Golestan 4th alley, Nahid Ave, Marzdaran
City
Tehran
Province
Tehran
Postal code
1461643744
Phone
+98 21 2201 9258
Email
dr.parsanavid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data will be shared after masking the identity of participants
When the data will become available and for how long
The information will be available 3 months after print
To whom data/document is available
All the researchers and physicians
Under which criteria data/document could be used
Only for research purposes
From where data/document is obtainable
dr.parsanavid@gmail.com
Navid Parsa
What processes are involved for a request to access data/document
After receiving the email, information will be given in less than one week.