Comparison of the effect of local injection of betamethasone and ketorolac in treatment of patients with De Quervain`s tenosynovitis and diabetes
.
Design
Clinical trial with two parallel groups, double-blind, randomized, phase 4 on 60 patients. The rand function of Excel software was used for randomization.
Settings and conduct
We decided to compare the effectiveness of ketorolac as a non-steroidal anti-inflammatory drug versus betamethasone as a steroidal anti-inflammatory drug. Therefore, After visiting in the specialized orthopedic clinic and obtaining informed consent, Ketorolac or betamethasone will inject in a double-blind manner (doctor and patient) and its results in pain control will be studied and compared in two groups. Doctor's informed assistant will prepare the syringe containing the medicine and record patients' information for follow-up.
Participants/Inclusion and exclusion criteria
Patients with De Quervain`s tenosynovitis and controlled type 2 diabetes over 18 years of age can enter the study. Pregnant women, patients who have a history of local corticosteroid injection or previous surgery and fracture in the same wrist will not be included in the study.
Intervention groups
In this study, patients are randomly divided into two groups treated with betamethasone injection and ketorolac injection.
Main outcome variables
Investigating the effectiveness of ketorolac injection and comparing it with betamethasone in controlling the pain of De Quervain's tenosynovitis in diabetic patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220611055139N1
Registration date:2022-08-19, 1401/05/28
Registration timing:registered_while_recruiting
Last update:2022-08-19, 1401/05/28
Update count:0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
Mehdi Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 950 2079
Email address
zare.mehdi8911215083@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-10, 1401/05/19
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Betamethasone and Ketorolac Injection on Treatment of De Quervain`s Tenosynovitis in Diabetic Patients
Public title
Comparing the Effect of Betamethasone and Ketorolac Injection on Treatment of De Quervain`s Tenosynovitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
De Quervains Tenosynovitis Patients
Diabetes mellitus Type 2 Patients
Persons more than 18 yo ages
Exclusion criteria:
History of Allergic Reaction to Lidocaine ،Ketorolac (and other NSAIDs) ،Aspirin and Betamethasone
History of Corticosteroids Injection in past 3 months
History of surgery due to De Quervain`s Tenosynovitis in same wrist
Pregnant ،Breastfeeding period and Patient with Gestational Diabetes
Skin complications such as wounds, eczema or rash at the injection site
Active infection at the injection site
History of acute wrist trauma, history of wrist fracture, rheumatoid arthritis, uncontrolled diabetes
Patients with type 1 diabetes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size of 60 patients was divided into 10 blocks with different random sizes of 4, 6 and 8 (3 blocks of 4, 4 blocks of 6, 3 blocks of 8) using the Permuted block randomization method by Excel computer software. Then the people of each block are randomly and equally divided into two groups under treatment A or B, and finally 30 patients will be treated with A and 30 patients will be treated with B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Considering the proven effectiveness of both betamethasone and ketorolac in the treatment of De Quervains patients, in a randomized and double-blind manner, neither the treating doctor nor the patient knows about the drug in the syringe, and the preparation and recording of information is the responsibility of the physician's assistant who It is aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Imam Khomeini Hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.UMSU.REC.1401.105
Health conditions studied
1
Description of health condition studied
De Quervains tenosynovitis
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
The amount of pain described by the patient
Timepoint
first session, 6 week, 3 months ,6 months after injection
Method of measurement
Visual Analogue Scale Score
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Local injection of 1 cc betamthasone (1cc/4 mg-Darou Pakhsh Pharmaceutical Manufacturing Company) with 1 cc Lidocaine 2% approximately 2 cm proximal to radius styloid، in first extensor tendons compartment of wrist
Category
Treatment - Drugs
2
Description
Second Intervention group: Local injection of 1 cc ketorolac (1cc/30 mg-Darou Pakhsh Pharmaceutical Manufacturing Company) with 1 cc Lidocaine 2% approximately 2 cm proximal to radius styloid، in first extensor tendons compartment of wrist
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital of Urmia
Full name of responsible person
Mehdi Zare
Street address
Imam Khomeini hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 935 950 2079
Email
Zare.mehdi8911215083@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mehdi Zare
Street address
Imam khomeini hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 935 950 2079
Email
Zare.mehdi8911215083@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Mehdi Zare
Position
Resident of Orthopaedics surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
Zare.mehdi8911215083@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mehdi Zare
Position
Resident of Orthopaedics Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
Zare.mehdi8911215083@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mehdi Zare
Position
Resident of Orthopaedics Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini hospital, Ershad Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
Zare.mehdi8911215083@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available