Comparison of the Effect of 5% Dextrose Water Injection with Corticosteroid Injection on Improving Clinical Signs and Performance of Patients with Mild to Moderate Cartilage Tunnel Syndrome in Patients Referring to Isfahan University of Medical Sciences Clinics during 2018: A Randomized Clinical Trial
The aim of this study was to assess the effect of 5% dextrose water injection compared to corticosteroid injection to improve clinical symptoms and performance of patients with mild to moderate carpal tunnel syndrome
Design
In this study, 36 patients with carpal tunnel syndrome (according to physician confirmation) were randomly divided into two equal groups and one group was treated with 5% Dextrose Water Injection and other group triamcinolone acetonide ( corticosteroid.)
Settings and conduct
In this study, 36 patients with carpal tunnel syndrome (according to physician confirmation) referred to Alzahra hospital were randomly divided into two equal groups and one group was treated with 5% Dextrose Water Injection and other group triamcinolone acetonide ( corticosteroid.)
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with mild to moderate carpal tunnel syndrome; patients with severe carpal tunnel syndrome. Exclusion criteria: patients with methemoglobinemia, favism and severe liver disease and thyroid disease; sensitization and allergy to local anesthetics; diseases that imitate symptoms of carpal tunnel syndrome such as cervical radiculopathy, peripheral neuropathy and trauma; corticosteroid injections and physiotherapy in the last three weeks; history of hand surgery in the last 6 months; having other neurological disorders.
Intervention groups
Group A: 5% Dextrose Water Injection
Group B: triamcinolone acetonide ( corticosteroid)
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N4
Registration date:2019-05-16, 1398/02/26
Registration timing:retrospective
Last update:2019-05-16, 1398/02/26
Update count:0
Registration date
2019-05-16, 1398/02/26
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-04-09, 1397/01/20
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison of the Effect of 5% Dextrose Water Injection with Corticosteroid Injection on Improving Clinical Signs and Performance of Patients with Mild to Moderate Cartilage Tunnel Syndrome in Patients Referring to Isfahan University of Medical Sciences Clinics during 2018: A Randomized Clinical Trial
Public title
Effect of 5% dextrose water injection compared to corticosteroid injection to improve clinical symptoms and performance of patients with mild to moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate carpal tunnel syndrome
Exclusion criteria:
Patients with severe carpal tunnel syndrome
Patients with methemoglobinemia, favism and severe liver disease and thyroid disease
Sensitization and allergy to local anesthetics
Diseases that imitate symptoms of carpal tunnel syndrome such as cervical radiculopathy, peripheral neuropathy and trauma
Corticosteroid injections and physiotherapy in the last three weeks
History of hand surgery in the last 6 months
Having other neurological disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
We divide each referral into two groups using a randomized table. This table is a collection of numbers. Consider numbers from 1 to 18 for intervention A and numbers 19 to 36 for B. Then let's move on one of the numbers and move in one of the preset directions and assign the numbers to one of the groups. Thus, patients are completely randomly divided.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients did not aware about prescription drugs (Dextrose Water and Corticosteroid)
Placebo
Not used
Assignment
Parallel
Other design features
In this study, 36 patients with carpal tunnel syndrome (according to physician confirmation) were randomly divided into two equal groups and one group was treated with 5% Dextrose Water Injection and other group corticosteroid.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-01-17, 1397/10/27
Ethics committee reference number
IR.MUI.MED.REC.1397.185
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
Severity of disease
Timepoint
Before treatment, 4 weeks and 12 weeks after treatment
Method of measurement
According to the questionnaire of 11 items of the severity of tunnel carpal syndrome
Secondary outcomes
1
Description
Severity of disease
Timepoint
Before treatment, 4 weeks and 12 weeks after treatment
Method of measurement
According to VAS scale
Intervention groups
1
Description
Intervention group A: Patients in this group were administered with acetaminophen (500 mg/ 6 hour during 2 weeks) and vitamin B6 (40 mg/daily) during 1 months. Then, patients were injected with Dextrose water 5% at a meeting.
Category
Placebo
2
Description
Intervention group B: Patients in this group were treated with acetaminophen (500 mg every 6 hours for 2 weeks) and vitamin B6 (40 mg / day) for 1 month. Then patients were injected with 1 cc triamcinolone acetonide (40 mg / ml diluted by 1 cc normal salin)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Safoura Aghaee
Street address
Isfahan University of Medical Science,Hezar Jareeb Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Fax
Email
Saghaei826@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooi Javanmard
Street address
Isfahan University of Medical Science,Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
Email
saghaei826@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Safoura Aghaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jareeb, Isfahan
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Fax
Email
saghaei826@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safoura Aghaee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jareeb , Isfahan
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Fax
Email
saghaei826@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safoura
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Alzahra hospital, Soffeh Blvd, Keshavarzi Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
Saghaei826@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data were collected from two groups of patients and may be available to physicians in the future.
When the data will become available and for how long
The next one years
To whom data/document is available
Physicians
Under which criteria data/document could be used
If physical medicine need the results, I present them
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document