Protocol summary
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Study aim
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Determination of the results of steroid injection by proximal and distal methods on the symptoms and function of patients with mild to moderate carpal tunnel syndrome
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Design
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Two arm parallel group randomised clinical trial , design for 34 hands in each group, enrolled between
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Settings and conduct
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Population under study will include patients suspected of Carpal Tunnel Syndrome (CTS) referred to Iran Rehabilitation Center, from physical medicine and rehabilitation, orthopedic, and rheumatology clinics during 2018 time period
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) Mild to moderate CTS based on Electrodiagnostic findings;
2) Older than 18 years old;
Exclusion criteria:
1) severe CTS with persistent pain & numbness;
2) a previous history of CTS injection 6 months ago;
3) a previous history of using CTS night splint;
4)a previous history of Carpal Tunnel Release surgry;
5) corticosteroid contraindication;
6) corticosteroid allergy;
7) Malignancy;
8) inflammation;
9) Pregnancy;
10) the presence of neurologic disorders;
11) Patients who have a surgical indication;
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Intervention groups
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Patients will be divided into two groups. First group will be injected by 40mg methyl prednisolone (proximal to crease); and, second group will be injected by 40mg methyl prednisolone (distal to crease) (palmar). It should be mentioned that both groups will use wrist static splint as a confirmed
and standard treatment for a period of 3 months, just at nights
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Main outcome variables
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1.Electrodignostic findings
2. Comparison of symptom severity
3. Comparison of functional status
General information
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Reason for update
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Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
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Acronym
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CTS
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IRCT registration information
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IRCT registration number:
IRCT20180804040685N1
Registration date:
2018-11-07, 1397/08/16
Registration timing:
prospective
Last update:
2021-02-25, 1399/12/07
Update count:
1
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Registration date
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2018-11-07, 1397/08/16
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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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2018-09-23, 1397/07/01
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Expected recruitment end date
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2019-03-11, 1397/12/20
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Actual recruitment start date
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2019-01-22, 1397/11/02
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Actual recruitment end date
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2019-12-11, 1398/09/20
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Trial completion date
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2020-03-11, 1398/12/21
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Scientific title
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Comparison of the efficacy of steroid injection via proximal and distal approach on the symptoms and function in patients with mild and moderate Carpat Tunnel Syndrome
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Public title
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Distal jnjection in Carpal tunnel syndrome ; Effect of Proximal injection 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:
Mild to moderate CTS based on Electrodiagnostic findings
Older than 18 years old
Exclusion criteria:
Severe CTS with persistent pain & numbness;
Previous history of CTS injection 6 months ago;
Previous history of using CTS night splint;
Previous history of Carpal Tunnel Release surgery ;
Corticosteroid contraindication;
Corticosteroid allergy;
Malignancy;
Inflammation;
Pregnancy;
Presence of neurologic disorders;
Patients who have a surgical indication;
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Age
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From 18 years old
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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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No information
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Sample size
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Target sample size:
32
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Based on the quadruple number block ;
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2018-09-18, 1397/06/27
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1397.444
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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Electrodignostic findings
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Timepoint
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Assessment of changes in electrodiagnostic tests at the beginning of the study (before intervention) and 3 months after steroid injection
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Method of measurement
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EMG-NCV machine
Secondary outcomes
1
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Description
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Symptom severity
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Timepoint
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Beginning of the study (before intervention) and 3 months after steroid injection
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Method of measurement
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Visual Analogue Scale
2
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Description
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Functional status
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Timepoint
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Beginning of the study (before intervention) and 3 months after steroid injection
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Method of measurement
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Boston carpal tunnel questionnaire
Intervention groups
1
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Description
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Intervention group : Injection (40 mg Methyl prednisolone) distal to crease; All injections would be made via insulin needle (gauge 29, and length 2.1 inch). Distal method injection takes place on volar section under wrist crease (palmar) and needle entrance angle would be 5-10 degrees or parallel to the arm (In this case wrist would be placed at dorsiflexion state 40-50 degrees). One and three months after the injection, patients will be reevaluated in terms of severity of symptoms and three months after the injection, patients will be reevaluated in terms of severity of symptoms and functional status (VAS- Boston questionnaires) .
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Category
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Treatment - Drugs
2
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Description
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Control group:Injection (40 mg Methyl prednisolone) proximal to crease; . All injections would be made via insulin needle (gauge 29, and length 2.1 inch). proximal method injection takes place in volar section (upper part of wrist crease) and medial side of Palmaris longus tendon; while, needle entrance angle is 30-40 degrees. One and three months after the injection, patients will be reevaluated in terms of severity of symptoms and functional status (VAS- Boston questionnaires) .
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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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Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available