70 patients with carpal tunnel syndrome in the wrist comprised the study population and did not respond to supportive treatment and were hospitalized in Ayatollah Taleghani Hospital. Patients were classified into two groups of surgery (35 people per each group) by classical incision method and 1-2 mm margin removal from the ulnar tunnel for carpal tunnel syndrome surgery. Boston questioner complete outpatient before and 6 month after surgery, participants and parson who collected questioners don't know about the type of surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who were diagnosed with the disease based on clinical and electrodiagnostic symptoms, did not respond to non-surgical treatments, at least 6 months have passed since their illness or at least one of the criteria: disease period more than 10 months, age older than 50 years, Phalen-positive test for less than 30 seconds, permanent anesthesia, Tenosynovitis at the first visit.
Exclusion criteria: Thenar atrophy, history of early carpal tunnel surgery, history of wrist fracture, pregnancy, history of tendon injury and wrist surgery, presence of a lesion on the wrist.
Intervention groups
Patients were classified into two groups of surgery by classical incision method and 1-2 mm margin removal from the ulnar tunnel for carpal tunnel syndrome surgery
Main outcome variables
Boston questioner (evaluate pain and function)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200307046711N2
Registration date:2021-06-25, 1400/04/04
Registration timing:prospective
Last update:2021-06-25, 1400/04/04
Update count:0
Registration date
2021-06-25, 1400/04/04
Registrant information
Name
Narges Nikpay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9040
Email address
n_nikpay@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-05, 1400/04/14
Expected recruitment end date
2022-02-03, 1400/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two surgical methods (classical incision method and 1-2 mm margin removal method by ulnar tunnel) in treating carpal tunnel syndrome
Public title
Comparing two types of surgical methods in treating carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed carpal tunnel syndrome based on clinical and electrodiagnostic symptoms
No respond to non-surgical treatments at least after 6 months or at least one of the criteria: disease period more than 10 months, age older than 50 years, Phalen-positive test for less than 30 seconds, permanent anesthesia, Tenosynovitis at the first visit
Exclusion criteria:
Thenar atrophy
History of early carpal tunnel surgery
History of wrist fracture, pregnancy
History of tendon injury and wrist surgery
Presence of a lesion on the wrist
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants allocate in to two groups by block randomized method, blocks in size of four are considered, first group is shown with A character and the second with B. by use of random allocation software sequence of different permutations of quadric blocks are made that define allocation of participants in groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and person who accumulate Boston questioner, don't know the type of surgery because operation is done by another person in hospital. Boston questioners are completed outpatient by orient person before and 6 month after surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah university of medical science
Street address
Shahid beheshti Blvd, Kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-08-21, 1399/05/31
Ethics committee reference number
IR.KUMS.REC.1399.468
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
Boston questioner(pain and function)
Timepoint
Before and 6 months after intervention
Method of measurement
Boston questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: carpal tunnel syndrome surgery by resection of 1-2 millimeters from ulnar side
Category
Treatment - Surgery
2
Description
Control group: Control group: carpal tunnel syndrome surgery by classic incision
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleqani hospital
Full name of responsible person
Ali mousapoor
Street address
Beheshti Blvd, Kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 7752
Email
ali.mousapour@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Shahid Beheshti Blvd, kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 7752
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Saeid Nikbakht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd, kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Email
Saeidnikbakht00@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeid Nikbakht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd, kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Email
Saeidnikbakht00@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeid Nikbakht
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blvd, kermanshah town
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7989
Email
Saeidnikbakht00@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Collected data is shareable after people were deidentified.
When the data will become available and for how long
Starting 6 months after publication.
To whom data/document is available
The data is available only for people who work in academic institutions.