Protocol summary
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Study aim
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Comparison of the effectiveness of local corticosteroid injection with injection of dextrose 5% solution in patients with carpal tunnel syndrome.
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Design
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Double blinded randomized control trial.
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Settings and conduct
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This study will be conducted on physical medicine and rehabilitation department of Rasool Akram hospital, Tehran, Iran. Patients with mild to moderate carpal tunnel syndrome (based on electrodiagnostic study) will be included in the study. Patients will be categorized into one of the following groups, using block randomization method:
A Group: Will receive ultrasound-guided injection of 1CC triamcinolone into carpal tunnel.
B Group: Will receive ultrasound-guided injection of 5 CC dextrose 5% into carpal tunnel.
Patients in the both groups will receive the conservative treatments for carpal tunnel syndrome including wrist splints for six weeks as well.
Patients will be followed after 2 weeks, one month and 6 months after injections. The pain intensity (Visual analogue scale) and the electrodiagnostic parameters are the main outcomes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Clinical diagnosis of carpal tunnel syndrome based on history (paresthesia over the distribution of median nerve) and possitive Tinnel and Phalen's tests.
2- Mild to moderate severity based on electrodiagnostic study.
3- Age between 18-65 years.
exclusion criteria:
Severe CTS, thenar atrophy, contraindication for injection, previous treatment , Neoplasm or trauma,tenderness and fracture of wrist, cervical radiculopathy, polyneuropathy.
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Intervention groups
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A Group: Ultrasound-guided injection of 1CC triamcinolone into carpal tunnel.
B Group: Ultrasound-guided injection of 5 CC dextrose 5% into carpal tunnel.
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Main outcome variables
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Pain intensity (Visual analogue scale) and the electrodiagnostic parameters.
General information
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Reason for update
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A few days before 2019-12-10, I had requested for expected recruitment date to be on 2019-12-10. but unfortunately my request was accepted two days later and now the chief editor wants to know if I started my clinical trial 2 days sooner! but I didn`t. I started it exactly on 2019-12-12 after getting confirmation. the reason was busy schedule of the person who confirmed the registration on 12th . I forgot to write down the achieved date of starting my clinical trial and now I want to update that. thanks
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Acronym
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CTS
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IRCT registration information
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IRCT registration number:
IRCT20180603039969N1
Registration date:
2019-12-12, 1398/09/21
Registration timing:
registered_while_recruiting
Last update:
2020-07-13, 1399/04/23
Update count:
1
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Registration date
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2019-12-12, 1398/09/21
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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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2019-12-10, 1398/09/19
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Expected recruitment end date
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2020-01-09, 1398/10/19
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Actual recruitment start date
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2019-12-12, 1398/09/21
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Actual recruitment end date
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2019-12-18, 1398/09/27
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Trial completion date
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2020-06-18, 1399/03/29
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Scientific title
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Comparison of the effectiveness of ultrasound-guided local corticosteroid injection with dextrose 5% solution injection in carpal tunnel syndrome.
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Public title
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Comparison of effectiveness of corticosteroid with dextrose in 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:
Patients with clinical diagnosis of carpal tunnel syndrome (paresthesia over the median nerve territory in the hand).
Mild to moderate severity of carpal tunnel syndrome, based on electrodiagnostic studies.
Age between 18-65 years,
Exclusion criteria:
Severe CTS ( based on electrodiagnostic data).
Signs of thenar atrophy.
Contraindication for injection ( such as history of hypersensitivity to corticosteroid, signs of local infection, immune deficiency, needle phobia.
Diseases that mimic symptoms of carpal tunnel syndrome such as polyneuropathy, radiculopathy, and thoracic outlet syndrome.
Surgical treatment or local injection in the last six months.
Neoplastic or traumatic origin.
Tenderness and fracture of wrist bones.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
54
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be categorized into one of the following groups, using block randomization method:
Group A) Will receive ultrasound-guided injection of 1 ml triamcinolone (40 mg) into the carpal tunnel.
Group B) Will receive ultrasound-guided injection of 5 ml dextrose 5% into the carpal tunnel.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patient and the investigator are kept blinded. The injecting syringe is covered with sterile gas. Therefore, the investigator will be kept blinded to the type of injecting solution. Furthermore, the patient will be kept blinded to the type of injecting solution.
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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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2018-11-20, 1397/08/29
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Ethics committee reference number
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IR.IUMS.FMD.REC.1397.216
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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Pain intensity (Visual analogue scale)
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Timepoint
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Baseline, and after 2 weeks, one month and 6 months after injection.
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Method of measurement
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10 point VAS scale.
2
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Description
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Electrodiagnosis parameters
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Timepoint
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Baseline, and after 2 weeks, one month and 6 months after injection.
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Method of measurement
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Electrodiagnostic study machine
Intervention groups
1
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Description
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One session of ultrasound-guided 1 CC Triamcinolone (Exir co, Tehran, Iran) injection into the carpal tunnel.
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Category
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Treatment - Drugs
2
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Description
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One session of ultrasound-guided 5 CC dextrose 5% solution (Ghazi co, Tehran, Iran) injection into the carpal tunnel.
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Category
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Treatment - Drugs
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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80
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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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Persons
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 collected data can be shared after making patients anonymous.
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When the data will become available and for how long
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Starting 6 months after publication.
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To whom data/document is available
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Data will be available for researchers on the internet.
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Under which criteria data/document could be used
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Data will be shared based on the request of the researchers.
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From where data/document is obtainable
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Dr. Babaei, Physical medicine department, Rasoul-akram hospital, Satarkhan Street, Tehran, Iran.
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What processes are involved for a request to access data/document
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Data will be sent via Email.
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Comments
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