Determination of the therapeutic effect of taking spike thumb plaster after injection of decron's disease in the rate of recovery of patients by age
Determination of the therapeutic effect of taking spike thumb plaster after injection of decron's disease in the rate of recovery of patients by gender
Determination of the therapeutic effect of taking spike thumb plaster after injection of decron's disease in the recovery rate of patients based on underlying disease
Determination of the therapeutic effect of taking spike thumb plaster after injection of decron's disease in the recovery rate of patients based on smoking
Design
Clinical trial with control group،randomized, on 60 patients of the intervention group and 82 patients of the control group. Rand function is used to randomize Excel software.
Settings and conduct
Clinical trial,bowali hospital in tehran
We examine the De quervain's patients who visit the boweli hospital, some of whom we treat only with topical injection therapy methyl prednisolone, and some of whom we take thumb spica cast in addition to the injection,, two to three weeks later we open the cast and check the abilities of the two groups based on two Vas and DASH questionnaires.
Participants/Inclusion and exclusion criteria
Entry requirements: visit to the Bowali hospital
Consent to participate in the study
Conditions for non-entry: incomplete patient information
Lack of access to the patient to follow up on the outcome of the treatment
Intervention groups
Intervention group: taking spyca thumb plaster after injection treatment methyl prednisolone acetate (1 cc) with 1 cc lidocaine 2%
Control group: injectable treatment of methyl prednisolone acetate (1 cc) with 1 cc of lidocaine 2%
Main outcome variables
Improvement of symptoms and pain of the patient's thumb
General information
Reason for update
Acronym
گچ اسپایکا، شست، بیماری دکرون
IRCT registration information
IRCT registration number:IRCT20240122060766N1
Registration date:2024-02-16, 1402/11/27
Registration timing:registered_while_recruiting
Last update:2024-02-16, 1402/11/27
Update count:0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
Suede hanieh Mohseni moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2612 7209
Email address
mohseni.hanieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-23, 1402/11/03
Expected recruitment end date
2024-02-17, 1402/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of thumb spica cast after De quervain's disease injection on the recovery rate of patients
Public title
Investigating the therapeutic effect of thumb spica cast after De quervain's disease injection on the recovery rate of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Visit to the Bowali hospital
Exclusion criteria:
Incomplete patient information
Lack of access to the patient to follow up on the outcome of the treatment
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the study so that the patient and the doctor both do not know about the selected treatment group
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with dekron disease visiting the Bowali hospital in Tehran who are eligible to enter the study will be randomly selected and randomly divided into two groups of witnesses and interventions, so that the patient and the researcher will not know about the treatment received to relieve the symptoms of the thumb.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Islamic Azad University of Tehran Medical Sciences Unit
Street address
Zargande at,shariati at,tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2022-09-27, 1401/07/05
Ethics committee reference number
IR.IAU.TMU.REC.1401.215
Health conditions studied
1
Description of health condition studied
De quervain disease
ICD-10 code
M67.8
ICD-10 code description
Other specified disorders of synovium and tendon
Primary outcomes
1
Description
Improved wrist and thumb pain in de quervain's patients
Timepoint
One month
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention group: thumb spica plaster after injection treatment methyl prednisolone acetate (1 cc) with 1 cc lidocaine 2%
Category
Treatment - Devices
2
Description
Control group:injectable treatment of methyl prednisolone acetate (1 cc) with 1 cc of lidocaine 2%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bowali Hospital
Full name of responsible person
Dr Saeed Pezeshki
Street address
Bowali Hospital,Damavand A Imam Ali Exp,Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ms Shahab pour
Street address
Zargande AVE,shariati street,tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?