Comparison of the effectiveness of local corticosteroid injection and local ozone injection in patients with carpal tunnel syndrome (CTS)
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, 42 patients, Randomized by block random method
Settings and conduct
Location:
Physical Medicine and Rehabilitation Clinic of Shahid Sadoughi Hospital, Yazd
Intervention:
21 patients in group 1 (treated with triamcinolone): injection of 40 mg of triamcinolone plus 1 ml of 1% lidocaine with ultrasound guidance around the median nerve and use of wrist splint for eight weeks
21 patients in group 2 (ozone treatment): 4 cc of ozone with a concentration of 10 mg plus 1 ml of 1% lidocaine with ultrasound guidance around the median nerve and using a splint wrist for eight weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Patients over 18 years
2) Patients with signs and symptoms of CTS approved by EMG-NCS and with mild to moderate severity based on electrodiagnostic criteria
Exclusion Criteria:
1) Perform previous interventions (such as the history of injections, use of splints in the past six months, or any surgery on the carpal tunnel) up to six months before the intervention
2) History of underlying diseases such as diabetes, rheumatoid arthritis, etc
3) Patients treated with ACE-I drugs
4) Patients with severe CTS
Intervention groups
Group 1: Corticosteroid injection Group 2: Ozone injection (both under ultrasound guidance around the median nerve by a physical medicine and rehabilitation specialist)
Main outcome variables
Severity of symptoms and functional limitations by Boston questionnare Severity of symptoms by VAS. Electrodiagnostic criteria by EMG-NCV Sonographic criteria by Sonographic device Side effects by questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210920052535N1
Registration date:2022-06-26, 1401/04/05
Registration timing:retrospective
Last update:2022-06-26, 1401/04/05
Update count:0
Registration date
2022-06-26, 1401/04/05
Registrant information
Name
Farnaz Hesam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 6689
Email address
f.hesam@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
2021-05-24, 1400/03/03
Actual recruitment end date
2021-06-17, 1400/03/27
Trial completion date
2021-08-11, 1400/05/20
Scientific title
Comparison of the effectiveness of local corticosteroid injection and local ozone injection in patients with carpal tunnel syndrome (CTS)
Public title
Comparison of the effectiveness of ozone and corticosteroid injections in the treatment of CTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years with signs and symptoms of carpal tunnel syndrome confirmed by Electrodiagnostic study and have mild to moderate CTS according to it.
Exclusion criteria:
Age under 18 years
Severe carpal tunnel syndrome
Presence of underlying diseases such as diabetes, rheumatoid arthritis, thyroid disease and previous history of trauma
Presence of thenar atrophy and peripheral nerve lesions of the upper extremity, polyneuropathy and radiculopathy
Pregnancy, history of G6PD deficiency, thrombocytopenia, severe cardiovascular instability, people are receiving ACE-I
History of injection or using a splint during the past 6 months or any previous surgery on the carpal tunnel
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
46
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was applied. In this method, patients were randomly divided into two groups using a table of random numbers by computer and online (using the site www.random.org/integres)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, the person who is completing the questionnaires and collecting the information, the person analyzing the information will be unaware of the group therapy and the type of injected substance
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Central building of Yazd University of Medical Sciences, Bahonar Sq, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2021-05-19, 1400/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.099
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
The severity of symptoms and functional limitations
Timepoint
Zero and 8th week
Method of measurement
Boston questionnaire was applied
2
Description
The severity of symptoms
Timepoint
Zero and 8th week
Method of measurement
Visual Analog Scale(VAS)
3
Description
Electrodiagnostic criteria
Timepoint
Zero and 8th week
Method of measurement
EMG-NCS device was applied
4
Description
Sonographic criteria
Timepoint
Zero and 8th week
Method of measurement
Sonographic device was applied
Secondary outcomes
1
Description
Side effects
Timepoint
8th week
Method of measurement
Questionnaire
Intervention groups
1
Description
First Intervention group: corticosteroid (40mg Triamcinolone) injection under the ultrasound-guide around the median nerve.
Category
Treatment - Drugs
2
Description
Second Intervention group: ozone (Ozone at a concentration of 10 micrograms per ml with 1 ml of 1% lidocaine) injection under the ultrasound-guide around the median nerve.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Farnaz Hesam
Street address
Ebne Sina St, Shahid Ghandi Blvd, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
f.hesam@rocketmail.com
Web page address
https://ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Central building of Yazd University of Medical Sciences, Bahonar Sq, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3146 2150
Email
f.hesam@rocketmail.com
Web page address
https://ssu.ac.ir
Grant name
Vice President of Research Yazd University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Farnaz Hesam
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ebne Sina St, Shahid Ghandi Blvd, safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
f.hesam@rocketmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amidodin khatibi Aghda
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Ebne Sina St, Shahid Ghandi Blvd, Safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
dr.khatibi_2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farnaz Hesam
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ebne Sina St, Shahid Ghandi Blvd, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
f.hesam@rocketmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Confirming the responsible person
From where data/document is obtainable
Dr Farnaz Hesam
f.hesam@rocketmail.com
What processes are involved for a request to access data/document