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General information
2021-04-21, 1400/02/01
2021-07-06, 1400/04/15
2021-0407-2106 00:00:00
empty
prevalence of covid 19 disease,The project executor became infected with covid 19 disease
prevalence of covid 19 disease,The project executor became infected with covid 19 disease
empty
شیوع بیماری کویید 19، ابتلا مجری طرح به بیماری کویید 19
شیوع بیماری کویید 19، ابتلا مجری طرح به بیماری کویید 19
Recruitment centers
#1
Name of recruitment center - English: Golestan hospital
Name of recruitment center - Persian: بیمارستان گلستان
Full name of responsible person - English: Saadat Maryam
Full name of responsible person - Persian: مریم سعادت
Street address - English: Mofid Ave., Golestan Blvd., Ahvaz Town., Golestan Hospital
Street address - Persian: اهواز، بلوار گلستان، خیابان مفید، بیمارستان گلستان
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 411366718596
Phone: +98 61 3374 3001
Fax:
Email: maryamsaadat2008@gmail.com
Web page address:
Name of recruitment center - English: Golestan hospital
Name of recruitment center - Persian: بیمارستان گلستان
Full name of responsible person - English: Saadat Maryam
Full name of responsible person - Persian: مریم سعادت
Street address - English: Golestan Hospital, Golestan Blvd,Ahvaz,Iran
Street address - Persian: ایران، اهواز، بلوار گلستان، بیمارستان گلستان
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 411366718596
Phone: +98 61 3374 3001
Fax:
Email: maryamsaadat2008@gmail.com
Web page address:
Name of recruitment center - English: Golestan hospital Name of recruitment center - Persian: بیمارستان گلستان Full name of responsible person - English: Saadat Maryam Full name of responsible person - Persian: مریم سعادت Street address - English: Mofid Ave.Golestan Hospital, Golestan Blvd., Ahvaz Town., Golestan HospitalBlvd,Ahvaz,Iran Street address - Persian: ایران، اهواز، بلوار گلستان، خیابان مفید، بیمارستان گلستان City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 411366718596 Phone: +98 61 3374 3001 Fax: Email: maryamsaadat2008@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saadat Maryam
Full name of responsible person - Persian: مریم سعادت
Street address - English: Golestan Blvd, Jundishapor University of Medical Sience
Street address - Persian: اتوبان گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135733133
Phone: +98 61 3374 3101
Fax:
Email: Ahvaz-rehab@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saadat Maryam
Full name of responsible person - Persian: مریم سعادت
Street address - English: Vice Chancellor for Research and Technology,Ahvaz Jondishapur University of Medical Sciences, golestan street, Ahvaz,Iran
Street address - Persian: ایران، اهواز، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور،معاونت تحقیقات و فناوری
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135733133
Phone: +98 61 3374 3101
Fax:
Email: Ahvaz-rehab@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Saadat Maryam Full name of responsible person - Persian: مریم سعادت Street address - English: Golestan Blvd, JundishaporVice Chancellor for Research and Technology,Ahvaz Jondishapur University of Medical SienceSciences, golestan street, Ahvaz,Iran Street address - Persian: اتوبانایران، اهواز، خیابان گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز،معاونت تحقیقات و فناوری City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135733133 Phone: +98 61 3374 3101 Fax: Email: Ahvaz-rehab@ajums.ac.ir Web page address:
Protocol summary
Study aim
The effects of conventional physical therapy with and without neck manual therapy on clinical outcomes in people with carpal tunnel syndrome
Design
Randomized control trial with 2 group of control and treatment design of 40 patients, double-blind, with a parallel group.
Settings and conduct
Patients are randomly assigned to either intervention or treatment groups at Golestan hospital in Ahvaz. In this study, patients and assessors are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Tingling, numbness, burning or pain in at least 2 of digits 1, 2 or 3.
Ages range between 18 to 60.
Positive result Phalen or Tinnel sign or Carpal compression test.
Existance CTS symptoms for greater than twelve weeks.
Pain intensity at least a 4/10 on a Visual Analog Scale over the past 24 h.
Electrodiagnostic findings indicate mild to moderate damage to the median nerve.
Exclusion criteria:
Any sensory or motor deficit in either the ulnar or radial nerve.
History of surgery or injection in the wrist area.
Presence of systemic diseases such as rheumatoid arthritis, fibromyalgia, diabetes mellitus , hyperthyroidism or hypothyroidism
The presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy.
Pregnancy.
History of neck, shoulder or upper extremity trauma.
Intervention groups
Intervention group: Combined conventional physiotherapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy and neck manual therapies.
Control group: Conventional physiotherapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy
Main outcome variables
Pain, upper limb level of function, symptoms and functional status of patients, median sensory nerve conduction velocity, median nerve motor distal latency
General information
Reason for update
prevalence of covid 19 disease,The project executor became infected with covid 19 disease
Acronym
IRCT registration information
IRCT registration number:IRCT20201201049565N1
Registration date:2020-12-15, 1399/09/25
Registration timing:registered_while_recruiting
Last update:2021-08-01, 1400/05/10
Update count:2
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Milad Zarrin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3524 7102
Email address
miladzarrin.pt1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-01, 1399/09/11
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of conventional physical therapy with and without neck manual therapy on clinical outcomes in people with carpal tunnel syndrome
Public title
The effects of neck manual therapy on the carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tingling, numbness, burning or pain in at least 2 of digits 1, 2 or 3
Ages 18-60 years
Positive Phalen sign or Tinnel sign over the carpal tunnel or carpal compression test
CTS symptoms present for greater than twelve weeks
Pain intensity at least a 4/10 on a Visual Analog Scale scale over the past 24 h
Electrodiagnostic findings indicate mild to moderate damage to the median nerve
Exclusion criteria:
Any sensory or motor deficit in either the ulnar or radial nerve
History of surgery or injection in the wrist area
Presence of systemic diseases such as rheumatoid arthritis, fibromyalgia
A history of systemic disease associated with carpal tunnel syndrome (such as diabetes mellitus or hyperthyroidism or hypothyroidism)
The presence of conditions that might cause numbness in the hand, including cervical radiculopathy, cervical ribs, plexopathy, and polyneuropathy
Pregnancy
History of neck, shoulder or upper extremity trauma
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who met the inclusion criteria were randomly
allocated to Group A (conventional physiotherapy) or Group B (combination of conventional physiotherapy treatments with neck manual therapy) using Block randomization (size: 4 and 6) prepare by an independent statistician with no clinical involvement in the trial. The allocation will be concealed in opaque, sealed envelope. A research assistant opens the envelopes to reveal group allocation before starting the intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind clinical trial in which patients are evaluated by another physiotherapist who is unaware of assigning individuals to groups. Patients and data analysts will also be unaware of group assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Deputy of Research and Technology, Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.AJUMS.REC.1399.727
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
Timepoint
One day before first session of treatment, two or three days after end of treatment
Method of measurement
Visual Analog Scale
2
Description
Upper limb level of function
Timepoint
One day before first session of treatment, two or three days after end of treatment
Method of measurement
Disabilities of the arm, shoulder and hand (DASH) questionnaire
3
Description
Symptoms and functional status of patients
Timepoint
One day before first session of treatment, two or three days after end of treatment
Method of measurement
Boston Carpal Tunnel(BCTQ) Questionnaire
4
Description
Median sensory nerve conduction velocity
Timepoint
One day before first session of treatment, two or three days after end of treatment
Method of measurement
Tru trace 4 EMG system DEYMED electromyography device
5
Description
Median nerve motor distal latency
Timepoint
One day before first session of treatment, two or three days after end of treatment
Method of measurement
Tru trace 4 EMG system DEYMED electromyography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combined conventional physical therapy including wrist splints, electrical stimulation, phonophoresis, and wrist manual therapy and neck manual therapies.
Category
Rehabilitation
2
Description
Control group: Conventional physical therapy including wrist splints, electrical stimulation, phonophoresis
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Saadat Maryam
Street address
Golestan Hospital, Golestan Blvd,Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
411366718596
Phone
+98 61 3374 3001
Email
maryamsaadat2008@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saadat Maryam
Street address
Vice Chancellor for Research and Technology,Ahvaz Jondishapur University of Medical Sciences, golestan street, Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
Ahvaz-rehab@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zarrin Milad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
miladzarrin.pt1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saadat Maryam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
maryamsaadat2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Milad Zarrin
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Physical therapy Department, Rehabilitation School, opposite the MRI Building, Jundishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
miladzarrin.pt1995@gmail.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
The person's information will be confidential and the results will be as collective statistics
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists.
When the data will become available and for how long
If the journal has requested access to the data at any time, the data will be provided.
To whom data/document is available
Journal editors and Reviewers
Under which criteria data/document could be used
Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable
Project manager
What processes are involved for a request to access data/document
It should be send email to project manager and after reviewing the reason for requesting the data, they will be send