Comparison of long term effectiveness of open surgery versus ultrasound guided median nerve hydrodissection in terms of symptoms , function and electrophysiological studies in patients with Canal Tunnel syndrome( CTS)
Comparison of long term effectiveness of open surgery versus ultrasound guided median nerve hydrodissection in terms of symptoms , function and electrophysiological studies in patients with CTS
Design
There are two groups of clinical trials
40 patients in the age range of 20 to 65 years with moderate to severe CTS were randomly divided into two groups of 20 people
random allocation is done in random blocks with block size 4 and block number 10. Thus, based on AABB letter permutations, we produce a list of 40 letters A and B and assign them to patients, respectively.
Settings and conduct
this study, were to Shahid Beheshti Hospital in Babol
The first group undergoes open surgery cut 2.5 cm in length at a distance of 1.5 cm We create a distal meter to the wrist in the direction of the fourth finger., we release the distal end of the transverse ligament to the proximal to show the median nerve
Participants/Inclusion and exclusion criteria
In this study, 40 patients with carpal tunnel syndrome who referred to Shahid Beheshti Hospital in Babol during 1397-1397 and will undergo open surgery and release of the median nerve with ultrasound vision with liquid and local steroid injection, are included in the study
Patients with systemic disease, such as inflammatory joint disease, diabetes, hypothyroidism, with a history of CTS surgery or nerve damage
Intervention groups
A group undergoes open surgery .
The other group undergoes median nerve release by ultrasound with fluid and topical steroid injections.
Main outcome variables
The rate of improvement in patients' symptoms
The rate of improvement in patients' function after open surgery
The rate of improvement of patients' electrophysiological parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141121020020N8
Registration date:2021-09-21, 1400/06/30
Registration timing:registered_while_recruiting
Last update:2021-09-21, 1400/06/30
Update count:0
Registration date
2021-09-21, 1400/06/30
Registrant information
Name
Shahram Seyfi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
sh.seyfi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of long term effectiveness of open surgery versus ultrasound guided median nerve hydrodissection in terms of symptoms , function and electrophysiological studies in patients with Canal Tunnel syndrome( CTS)
Public title
Comparison of long term effectiveness of open surgery versus ultrasound guided median nerve hydrodissection in terms of symptoms , function and electrophysiological studies in patients with Canal Tunnel syndrome( CTS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with carpal tunnel syndrome
referred to Shahid Beheshti Hospital in Babol during 1397-98
Exclusion criteria:
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation is done in random blocks with block size 4 and block number 10. Thus, based on AABB letter permutations, we produce a list of 40 letters A and B and assign them to patients, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.MUBABOL.HRI.REC
Street address
Keshavarz street rohani hospital
City
BABOL
Province
Mazandaran
Postal code
4717641367
Approval date
2021-08-22, 1400/05/31
Ethics committee reference number
IR.MUBABOL.HRI.REC.1400.045
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 rate of improvement in patients' symptoms
Timepoint
a special questionnaire for the evaluation of CTS patients, which is filled out once before surgery and three times at 1, 3 and 6 months after surgery
Method of measurement
This questionnaire was designed by David W et al., Which is the Boston questionnaire, which consists of two tables, one to assess symptoms and the other to assess patient performance. In total, the patient gets a score between 11-55 for symptoms and 8-40 for function
Secondary outcomes
1
Description
The rate of improvement of patients' electrophysiological parameters after open surgery and release of the median nerve
Timepoint
To evaluate patients, the electrophysiological study of patients (EMG-NCV) and a special questionnaire for the evaluation of CTS patients, which is filled out once before surgery and three times at 1, 3 and 6 months after surgery, are used to evaluate the outcome of the operation
Method of measurement
This questionnaire was designed by David W et al., Which is the Boston questionnaire, which consists of two tables, one to assess symptoms and the other to assess patient performance. In total, the patient gets a score between 11-55 for symptoms and 8-40 for function. The higher this number, the more severe the person's disease
Intervention groups
1
Description
We create a distal meter to the wrist in the direction of the fourth finger. After removing the adipose tissue and aponeurosis, we release the distal end of the transverse ligament. Then, this ligament formsIt is cut lengthwise from the distal to the proximal to show the median nerve
Category
Treatment - Surgery
2
Description
Intervention group: The second group, with the help of median nerve ultrasound from forearm to wrist under CFT ligament(Common Flexor Tendon) is specified. With the help of a special block needle that can be detected by sonography (Sonovisible needle), it is guided directly from the ulnar wrist under the CFT and by slow injection of the fluid combination with local anesthesia of bupivacaine and depomedrol, the median nerve is separated from the CFT
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شهید بهشتی و بیمارستان آیت اله روحانی
Full name of responsible person
Merafza Mir
Street address
جاده گنج افروز-خیابان کشاورز
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Email
mmir46@yahoo.com
2
Recruitment center
Name of recruitment center
بیمارستان شهید بهشتی و بیمارستان آیت اله روحانی
Full name of responsible person
Mehrafza Mir
Street address
Ganj Afrooz Road - Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Email
mmir46@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ghan afroz road-keshavarz streat
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Email
ficu_@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mehrafza Mir
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ganjafrooz Road - Keshavarz Street
City
BaboL
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8001
Email
sh.seyfi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehrafza Mir
Position
Assistant Professor of anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gangh afroz road-Keshavarz streat
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
009111139348
Email
sh.seyfi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
شهرام سیفی
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gangh afroz r4ioad-Keshavarz streat
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Email
sh.seyfi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no plans to publish it yet.
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