Protocol summary
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Study aim
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our aim in this study is to compare the effectiveness of two different methods of ultrasound-guided local corticosteroid injection in the treatment of patient with carpal tunnel syndrome
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Design
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in this study forty patients with carpal tunnel syndrome referred to Firuzgar physical medicine and rehabilitation clinic, Tehran, Iran will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent .patients will be randomly divided to two groups of twenty. For randomization we will use randomized blocking method
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Settings and conduct
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ultrasound-guided local injection of forty mg of triamcinolone with the in-plane method; in the first group with radial approach and in the second group with ulnar approach will be done by a physical medicine and rehabilitation specialist. Routine treatments including wrist splint for 6 weeks will be performed for all patients
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Participants/Inclusion and exclusion criteria
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in this study forty patients with carpal tunnel syndrome referred to Firuzgar physical medicine and rehabilitation clinic, Tehran, Iran will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent
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Intervention groups
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patients will be randomly divided to two groups of twenty. For randomization we will use randomized blocking method
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Main outcome variables
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Electrodiagnostical and sonographic criteria, Boston questionnaire scores and VAS will be assessed in the 0, 2th week, 6th week and 12th week.
General information
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Reason for update
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Acronym
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CTS,EMG-NCS, VAS, BQ-SS, BQ-SS
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IRCT registration information
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IRCT registration number:
IRCT20180205038619N1
Registration date:
2018-03-05, 1396/12/14
Registration timing:
registered_while_recruiting
Last update:
2019-02-09, 1397/11/20
Update count:
1
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Registration date
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2018-03-05, 1396/12/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-22, 1396/10/01
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Expected recruitment end date
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2018-08-23, 1397/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the two approaches, ulnar and radial injection with ultrasound guided in Carpal Tunnel ُSyndrome
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Public title
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Compare two different methods of ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Symptoms and signs of carpal tunnel syndrome (including pain and sensory disturbances in the Median nerve range) refer to the Physical Therapy and Rehabilitation Clinic and their disease is confirmed by EMG-NCS and Electrodiagnostic criteria have mild to moderate carpal tunnel syndrome They are entering the study
Exclusion criteria:
Severe Carpal Tunnel Syndrome with thenar atrophy Symptoms
Contraindication of corticosteroid injection (including corticosteroid allergy and localized infections symptoms)
Diseases that immitate CTS symptoms, such as polyneuropathy, cervical radiculopathy, thorasic outlet syndrome
Surgical treatment or topical injection in the last six months.
The origin of neoplastic or traumatic pain and fracture of the wrists.
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This is a double blind study in which patients and outcomes analyzer are blinded. In order to blind the patient, it is said that both materials are effective for treatment, but the type of substance is not mentioned for patients when its injected. In order to blind the analyzer, the persons responsible for injection and data collection are different from the outcome assessors.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-29, 1396/08/07
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Ethics committee reference number
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IR.IUMS.FMD.REC
Health conditions studied
1
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Description of health condition studied
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Carpal tunnel syndrome
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ICD-10 code
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G56.0
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ICD-10 code description
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Carpal tunnel syndrome
Primary outcomes
1
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Description
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The severity of symptoms and functional limitations
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Timepoint
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Zero, two, six and twelve weeks after
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Method of measurement
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By using Boston questionnare
2
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Description
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The severity of symptoms
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Timepoint
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Zero, two, six and twelve weeks after
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Method of measurement
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Visual Analog Scale(VAS)
3
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Description
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Electrodiagnostic criteria
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Timepoint
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Zero, two, six and twelve weeks after
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Method of measurement
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By using EMG-NCV device
4
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Description
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Sonographic criteria
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Timepoint
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Zero, two, six and twelve weeks after
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Method of measurement
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By using Sonographic device
Secondary outcomes
1
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Description
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Side effects
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Timepoint
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Two, six and twelve weeks after
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: corticosteroid inject under the ultrasound-guid radial side of the median nerve which will be done by an experienced physical medicine and rehabilitation specialist using in-plane approach.
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Category
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Treatment - Other
2
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Description
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Intervention group: Intervention group: corticosteroid inject under the ultrasound-guid ulnar side of the median nerve which will be done by an experienced physical medicine and rehabilitation specialist using in-plane approach.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All the patient's data can be shared with privacy in regard to patients name
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When the data will become available and for how long
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Start accessing 6 months after publishing the results.
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To whom data/document is available
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For scholars working in academic centers.
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Under which criteria data/document could be used
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It can be analyzed and printed by other people by mentioning the source
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From where data/document is obtainable
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katayounmoradi69@gmail.com
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What processes are involved for a request to access data/document
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Upon authentication, data is provided to the individual.
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Comments
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