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Comparison of efficacy and safety of intra-articular injection of dexmedetomidine and triamcinolone in improving knee pain and function in patients with primary knee osteoarthritis

Protocol summary

Study aim
Comparison of efficacy and safety of intra-articular injection of two drugs dexmedetomidine and triamcinolone in improving knee pain and function in patients with primary knee osteoarthritis
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2-3, was conducted on 60 patients, and a simple individual randomization method was used with the tool of sealed envelopes.
Settings and conduct
This study is conducted as a double-blind randomized clinical trial in patients with osteoarthritis of the knee referred to the pain clinic of Imam Hossein hospital in 2023.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 40 years and older, knee osteoarthritis pain for more than three months, radiological findings confirming knee osteoarthritis based on the American College of Rheumatology (ACR) criteria. Exclusion criteria: patients with a lack of consent based on participation in the project, patients with a history of knee surgery, deformity and contracture of the lower limb, neuromuscular disease of the lower limb, acute lumbar pathology, injection of steroid drugs in the last two months, history of inflammatory rheumatoid arthritis, infection, Diabetes, pregnancy, breastfeeding, BMI<35, patients who are candidates for knee surgery, presence of knee deviation (varus or valgus more than five degrees) which was confirmed by three joint view, presence of radiocular knee pain, use of anticoagulant drugs, arthritis after Trauma, history of intra-articular injection in the past 12 months, allergy to any of the drugs, severe osteoarthritis with grade more than III, drug and alcohol abuse.
Intervention groups
Intervention group: injection of dexmedetomidine 1 microgram per kilogram + 2 ml of 2% lidocaine inside the knee joint. Control group: injection of 40 mg of triamcinolone inside the knee joint
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130518013364N11
Registration date: 2023-09-27, 1402/07/05
Registration timing: prospective

Last update: 2023-09-27, 1402/07/05
Update count: 0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of intra-articular injection of dexmedetomidine and triamcinolone in improving knee pain and function in patients with primary knee osteoarthritis
Public title
Comparison of intra-articular injection of dexmedetomidine and triamcinolone in improving knee pain and function in patients with primary knee osteoarthritis.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years Presence of knee pain for more than 3 months Radiological findings confirming knee osteoarthritis based on American College of Rheumatology (ACR) criteria
Exclusion criteria:
Unwillingness to participate in the study Patients with a history of knee surgery Patients with lower limb deformity and contracture Patients with lower limb neuromuscular disease Patients with acute lumbar pathology Injection of steroid drugs during the last two months History of inflammatory rheumatoid arthritis History of recent infection in the knee Diabetes Pregnancy Breastfeeding BMI> 35 Candidate patients for knee surgery The presence of knee deviation (Varus or valgus more than five degrees) which was confirmed by three joint view The presence of radicular pain Taking anticoagulants Arthritis after trauma History of intra-articular injection of the knee during the last 12 months Allergy to any of the drugs used Chronic systemic disease Psychiatric illness Severe osteoarthritis with grade more than III Hepatitis Cytomegalovirus infection Having syphilis Having osteomyelitis Drug and alcohol abuse Having AIDS
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B will be as control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient herself and the doctor who evaluates the outcome in patients do not know the patient group (intervention group or control group)
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.267

Health conditions studied

1

Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee

Primary outcomes

1

Description
Pain
Timepoint
At the beginning of the study (before the start of the intervention) and one and three months after
Method of measurement
Visual analog scale

2

Description
The total score of the KOOS questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and one and three months after
Method of measurement
Based on asking the patient and scoring each of the items

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Injection of dexmedetomidine 1 microgram per kilogram + 2 ml lidocaine 2%, which is performed under ultrasound guidance with a 27-gauge needle inside the knee joint. The injection is done in one session.
Category
Treatment - Other

2

Description
Control group: Injection of one milliliter (40 mg) of triamcinolone + 2 ml of lidocaine 2%. The injection method is similar to the intervention group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospitalʼs pain clinic
Full name of responsible person
Mehrdad Taheri
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarqi
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Web page address
https://research.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street, Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street, Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Theri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street, Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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