Determining the therapeutic effect of intra-articular injection of dextrose in comparison with intra-articular injection of erythropoietin under ultrasound guidance in patients with knee osteoarthritis (OA)
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 42 patients. A lottery method was used for randomization
Settings and conduct
study is a double-blind randomized clinical trial (analysts do not know the type of treatment) on patients with knee OA who referred to the physical medicine clinics affiliated to Iran University of Medical Sciences in 2023-2024. The first group is treated with prolotherapy with dextrose and the second group is treated with intra-articular injection of erythropoietin. At the beginning, one month, 3 months and then 6 months after the injection, the response variables will be measured.
The obtained data are compared before and after and the amount of changes between the two groups. The obtained results are analyzed using appropriate statistical methods and SPSS24 statistical software.
Participants/Inclusion and exclusion criteria
1.Knee OA in grades 2-3 ( Lowrence-Kellergan criteria).
2. Knee pain for at least 6 months.
3. Age 18-75 years,
4. Absence of any acute/chronic infection,
5. Not getting/deciding to get pregnant.
6. Failure to perform any intra-articular injection of the knee during the last 3 months.
7. Absence of inflammatory joint diseases or secondary OA,
8. Not having a history of knee surgery,
9. Not having a severe underlying disease such as uncontrolled diabetes, anticoagulant use,
10. Not taking opioid & non-opioid painkillers daily.
Intervention groups
Comparison of the effect of intra-articular injection of erythropoietin with dextrose prolotherapy
Main outcome variables
Visual analog scale (VAS)
WOMAC questionnaire
General information
Reason for update
Acronym
CSIEDKO
IRCT registration information
IRCT registration number:IRCT20170910036107N8
Registration date:2024-04-12, 1403/01/24
Registration timing:prospective
Last update:2024-04-12, 1403/01/24
Update count:0
Registration date
2024-04-12, 1403/01/24
Registrant information
Name
Naseh Yousefi
Name of organization / entity
Iran university of medical science and health services
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 6574
Email address
nasehusefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Intraarticular Erythropoietin and Dextrose Prolotherapy in Knee Osteoarthritis
Public title
Comparative Study of Intraarticular Erythropoietin and Dextrose in Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with 2 and 3 knee osteoarthritis according to Lawrence-Kellgren criteria
knee pain for at least 6 months
ages from 18 to 75 years old
referring to the physical medicine department of Firuzgar and Rasul Akram hospitals.
Exclusion criteria:
absence of any acute or chronic infection
not getting pregnant or not deciding to get pregnant
not performed any intraarticular injection during last 3 months
absence of inflammatory joint diseases or secondary osteoarthritis
not having knee surgery
not having severe underlying diseases such as uncontrolled DM
not taking opioid or non-opioid analgesics
not taking anticoagulants
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
1 or 2 effected knee in 1 patient
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Block, Unit of randomization: Individual, Tools used in randomization: Table of random numbers
The present study is a three-blind randomized clinical trial. The patient analyst and the evaluator do not know the type of treatment. The drugs are prepared in advance and placed in the cover - Patients are randomly divided into two groups by Hidden sealed envelope randomization method. In such a way, an equal number of interventions are written in the same size sheets and the sheet is folded in such a way that the type of intervention is not clear. If the patient is selected for the study, will randomly pick up a sheet of envelope indicating the type of intervention.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is a three-blind randomized clinical trial. The patient analyst and the evaluator do not know the type of treatment. The drugs are prepared in advance and placed in the cover - each patient is given a code and according to the code of the type of drug It is determined that the patient, the analyst and the evaluator do not know about it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Science
Street address
Medical faculty, Iran University of Medical Science, Hemmat High way
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.IUMS.FMD.REC.1401.666
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
VAS and Womac scores
Timepoint
before injection, 1 month and 3 months after injection
Method of measurement
VAS score is described by the patient and womac score with questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Erythropoietin intraarticular injection. Under sterile conditions and after local anesthesia( 1 cc of lidocaine 2%), 4000 IU of erythropoietin is injected into the knee joint under ultrasound guidance and through the supra patellar patch (in one session).
Category
Treatment - Drugs
2
Description
Control group: Intra-articular injection of dextrose. Before injection, 1 cc of lidocaine 2% is used for local anesthesia of the skin and underlying tissues in both groups. Then, under sterile conditions, in a group of patients, 5 cc of 25% dextrose is injected under ultrasound guidance through the suprapatellar patch inside the knee joint (in one session).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation,Firoozgar Hospital
Full name of responsible person
Naseh Yusefi
Street address
Firoozgar Hospital, Behafarin Avenue
City
Teharn
Province
Tehran
Postal code
1593787711
Phone
+98 21 8214 1201
Email
nasehusefi@gmail.com
Web page address
https://oldsghc.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motovalian
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway
City
تهران
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Naseh Usefi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Email
nasehusefi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naseh Usefi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Email
nasehusefi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naseh Usefi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Email
nasehusefi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All the patient's data can be shared with privacy in regard to patients name
When the data will become available and for how long
En Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of documents is allowed only by mentioning the source
From where data/document is obtainable
En Naseh Usefi Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square. nasehusefi@gmail.com 0098 2182141612
What processes are involved for a request to access data/document
Upon authentication, data is provided to the individual