Comparing the effectiveness of using a drain with not using a drain during surgery in improving the symptoms and satisfaction of patients with bilateral carpal tunnel syndrome.
Comparing the effectiveness of using a drain with not using a drain during surgery in improving the symptoms and satisfaction of patients with bilateral carpal tunnel syndrome.
Design
The clinical trial, controlled, unblinded, with available sampling, on 35 patients with 70 arms.
Intervention group: hand of patients who underwent drain placement.
Control group: a hand of patients who did not undergo drain implantation.
Settings and conduct
The study population consists of patients with bilateral CTS referring to Shahid Sadoughi and Shahid Rahmon hospitals in Yazd, who are candidates for bilateral surgery. Sampling will be Convenience and then one of the hands that will be randomly selected will undergo drainage during the surgery. It will be placed and the other hand will be operated without inserting a drain. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with bilateral carpal tunnel syndrome
Failure to respond to non-surgical treatment for six months
The need for bilateral surgery according to the opinion of the hand surgeon
Exclusion criteria:
Age below 20 years
The patient's inability to cooperate
Debilitating upper limb diseases such as rheumatoid arthritis
Previous history of hand surgery
Intervention groups
Both hands of patients will undergo surgery. A drain will be placed in one hand after surgery (interventional group), and a drain will not be placed in the other hand (control group)
Main outcome variables
Patients' pain intensity (visual analog scale)
Symptom Severity Scale (Boston Questionnaire- SSS Scale)
Functional Status Scale (Boston Questionnaire - FSS Comparison)
Grip and Pinch Strength
Patient satisfaction with the result of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230407057839N1
Registration date:2023-12-26, 1402/10/05
Registration timing:registered_while_recruiting
Last update:2023-12-26, 1402/10/05
Update count:0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
mohammadreza farhadi rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4244 0301
Email address
mohammadreza138999@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of using a drain with not using a drain during surgery in improving the symptoms and satisfaction of patients with bilateral carpal tunnel syndrome.
Public title
The effect of using a drain in the surgery of patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having bilateral carpal tunnel syndrome (confirmed by history, Phalen examinations, compression test, Electromyography (moderate to severe)
failure to respond to non-surgical treatment for six months
the need for surgery on both hands (confirmed by a hand surgeon)
Consent to participate in the study with knowledge of the objectives of the study
Exclusion criteria:
Under 20 years of age
Lack of necessary cooperation by the patient
Conditions that caused upper extremity disability such as rheumatoid arthritis
Previous surgery at the carpal tunnel site
History of psychiatric diseases (psychosis) and neurological diseases (Parkinson's)
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Randomization unit: hand
Randomization tool: table of random numbers
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
Ethics committee of Shahid Sadoughi Yazd University of Medical Sciences
Street address
No. 1, Prof Hesabi Ave,
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2023-01-19, 1401/10/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.105
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
Pain intensity score
Timepoint
Measurement of VAS criterion before the start of the study, three weeks and 16 weeks after surgery
Method of measurement
Visual Analogue Scale
2
Description
Symptom Severity Scale
Timepoint
Completion of the Boston questionnaire before the start of the study, three weeks and 16 weeks after surgery
Method of measurement
Boston questionnaire (questions 1 to 11 related to the severity of symptoms)
Secondary outcomes
1
Description
palmar grip &pulp (fingertip) pinch
Timepoint
Perform palmar grip &pulp (fingertip) pinch test before the start of the study, three weeks and 16 weeks after surgery
Method of measurement
Pinch meter and palmar grip dynamometer
2
Description
Functional Status Scale
Timepoint
Completion of the Boston questionnaire before the start of the study, three weeks and 16 weeks after surgery
Method of measurement
Boston Questionnaire (questions 12 to 19 related to function)
Intervention groups
1
Description
Intervention group: The hand of the patient who is placed under a drain after carpal tunnel syndrome surgery
Category
Treatment - Surgery
2
Description
Control group: The hand of patients who do not undergo drainage after carpal tunnel syndrome surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Abbas Abdoli Tafti
Street address
No. 1, Prof. Hesabi Ave.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9137
Email
mohammadreza138999@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abas Abdoli
Street address
No, 1. Prof Hesabi Ave,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9137
Email
mohammadreza138999@yahoo.com
Grant name
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
Mohammad Reza Farhadi Rad
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 1, Prof. Hesabi Ave
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
0358915173160
Email
mohammadreza138999@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Reza Farhadi Rad
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 1, Prof. Hesabi Ave
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
0358915173160
Email
mohammadreza138999@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Reza Farhadi Rad
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 1, Prof. Hesabi Ave
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
0358915173160
Email
mohammadreza138999@yahoo.com
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