Evaluation of the effectiveness of Ultrasound-Guided Steroid Injection In one wrist in patients with bilateral carpal tunnel syndrome at opposite Injection side
Title:Results Survey of Ultrasound-Guided Steroid Injection In one wrist in patients with bilateral carpal tunnel syndrome at opposite Injection side
Design
Patients with CTS are injected with triamcinolone and lidocaine locally in one wrist (dominant hand)
Settings and conduct
physical medicine and rehabilitation clinic of Baqiyallah
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30-60 male or female patients with a final diagnosis of bilateral carpal tunnel syndrome with moderate intensity and pain or paresthesia in the hand.
Exclusion criteria: 1-Patients with severe carpal tunnel syndrome or severe dysfunction of the hand that requires release of the median nerve through surgery. 2- Patients who suffer from neuropathy, radiculopathy and median nerve damage, as well as patients who suffer from brachial plexopathy, radial and ulnar neuropathy, fractures in the upper limb, burns in the upper limb and any type of nerve lesion in the upper limb. 3-Patients who undergo hand surgery. 4- Patients who are allergic to steroids and lidocaine. 5- Patients who do not cooperate to follow up after injection. 6- Patients who have a history of trauma or upper limb burns.
Intervention groups
30 Patients with Moderate CTS Bilateral diagnosed by EDX test, the combination of triamcinolone and lidocaine including 1 cc of triamcinolone 40 mg and 1 cc of 2% lidocaine is injected locally in one wrist (dominant hand) (the hand that has been injected), then For all patients, a medical wrist brace with a splint (Cock up) is prescribed for the dominant hand (the hand that has been injected) for one month.
Main outcome variables
carpal tunnel syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230108057078N1
Registration date:2023-03-31, 1402/01/11
Registration timing:prospective
Last update:2023-03-31, 1402/01/11
Update count:0
Registration date
2023-03-31, 1402/01/11
Registrant information
Name
Sattar Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3344 3619
Email address
sattarn2a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Ultrasound-Guided Steroid Injection In one wrist in patients with bilateral carpal tunnel syndrome at opposite Injection side
Public title
Evaluation of the effectiveness of Ultrasound-Guided Steroid Injection In one wrist in patients with bilateral carpal tunnel syndrome at opposite Injection side
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients With Bilateral Moderate Carpal Tunnel Syndrome Suffering From Hands Pain & Paresthesia
No History Of Local Steroid Injection & Surgery
No Underlying Disorders Such As Diabetes mellitus (DM), Thyroid Disorders & Rheumatoid Arthritis
Within Range Of 30 To 60 Years Of Age Without Any Gender Limitation
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Sheikh Bahai - Mulla Sadra St. Vanak Square.Tehran
City
tehran
Province
Tehran
Postal code
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.BMSU.BAQ.REC:1401.031
Health conditions studied
1
Description of health condition studied
Bilateral carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Bilateral carpal tunnel syndrome
Timepoint
before the start of the intervention and 30 days after local steroid injection
Method of measurement
EDX
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with moderate bilateral CTS diagnosed by EDX test, the combination of triamcinolone and lidocaine including 1 cc of triamcinolone 40 mg and 1 cc of lidocaine 2% is injected locally in one wrist (dominant hand). The above-mentioned injections will be performed under ultrasound guide by hydrodissection of the Madin nerve. Then, for one month, a medical wrist brace with a splint (Cock up) is prescribed for the dominant hand for all patients And then clinical symptoms (through the Boston questionnaire) and electrophysiological findings including NCV, SNAP Latency, CMAP Latency of the median nerve of the opposite hand are checked and recorded one month after the treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital, Tehran
Full name of responsible person
Seyyed Ebrahim Hashemi
Street address
Baqiyatullah-ul-Azam Hospital ,Mollasadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 8805 0435
Email
bag@bmsu.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyyed Ebrahim Hashemi
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai St,Mollasadra St, ,Venk Square,
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 0000
Email
pr@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Satar Najafi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Baqiyatullah-ul-Azam Hospital ,Mollasadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
bag@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Satar najafi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Baqiyatullah-ul-Azam Hospital ,Mollasadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
bag@bmsu.ac.ir
Phone
+98 21 8805 0435
Email
bag@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Satar najafi
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Baqiyatullah-ul-Azam Hospital ,Mollasadra St, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 8805 0435
Email
bag@bmsu.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
Undecided - It is not yet known if there will be a plan to make this available
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