1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis in patients with knee osteoarthritis referring to pain clinics of Shohada Tajrish, Taleghani and Akhtar hospitals in 1397

Protocol summary

Study aim
Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis
Design
Randomized clinical trial without control group, double blind, 60 patients, phase 2-3
Settings and conduct
Location: Akhtar Hospital, Taleghani Hospital, Shohada Tajrish Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Signed written informed consent, 40 years of age and above, knee osteoarthritis for more than 3 months, Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology (ACR). Exclusion Criteria: knee surgery, deformity and lower limb contractions, neuromascular disease of the lower extremity, acute lumbosacral pathology, injection of steroid medications in the last two months, history of inflammatory rheumatoid arthritis, infection, Nursing mothers, BMI > 35, knee surgery, knee deviations (verrucous or valgus more than 5 degrees), anticoagulant therapy, post-traumatic arthritis, history of Intra-articular injection or ozone therapy for the past 12 months, allergy to any of the medications prescribed in this study, systemic or psychiatric disease, severe osteoarthritis of grade III, intra-articular injection of hyaluronic acid in the past 12 months,hepatitis, HIV, Cytomegalovirus, Syphlis, Osteomyelitis, Alcohol or substance abuse, diabetes, Pregnancy
Intervention groups
Orthokine treatment protocol (IL-1RA) consists of 6 injections, the first day and 3, 7, 10, 14 and 21 days after the first injection are done by physician A. Hyaluronic Acid group: two ml of hyaluronic acid solution (Synocrom 1% by Croma, Austria) is injected into the knee joint. Total number of 5 injections are given at intervals of one week by the physician B.
Main outcome variables
Total KOOS Score.Total WOMAC Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131124015515N6
Registration date: 2019-04-13, 1398/01/24
Registration timing: retrospective

Last update: 2019-04-13, 1398/01/24
Update count: 0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-15, 1397/10/25
Expected recruitment end date
2019-01-15, 1397/10/25
Actual recruitment start date
2019-01-15, 1397/10/25
Actual recruitment end date
2019-02-24, 1397/12/05
Trial completion date
2019-02-24, 1397/12/05
Scientific title
Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis in patients with knee osteoarthritis referring to pain clinics of Shohada Tajrish, Taleghani and Akhtar hospitals in 1397
Public title
Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis in patients with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Signed written informed consent to participate in the study Patients 40 years of age and above Patients suffering from knee osteoarthritis for more than 3 months Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology (ACR)
Exclusion criteria:
Patients' refusal to participate in clinical research Patients with a history of knee surgery Patients with deformity and lower limb contraction, Patients with neuromascular disease of the lower extremity, Patients with acute lumbosacral pathology Patients undergone injection of steroid medications in the last two months Patients with a history of inflammatory rheumatoid arthritis Patients with infection Nursing mothers BMI > 35 patients with knee surgery Patient with knee deviations (verrucous or valgus more than 5 degrees) confirmed by three joint views Patients with knee radicular pain Patients with anticoagulant therapy Patients with post-traumatic arthritis Patient with history of Intra-articular injection or ozone therapy for the past 12 months Patients with allergy to any of the medications will be prescribed in this study Patients with systemic or psychiatric disease Patients with severe osteoarthritis of grade III Patients with intra-articular injection of hyaluronic acid in the past 12 months Patients with hepatitis Patients with HIV Patients with Cytomegalovirus Patient with Syphlis Patient with Osteomyelitis Alcohol or substance abuse Patient with diabetes Pregnancy
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
En: The sampling method was sequential; so that, all eligible people referred respectively, and were selected to complete the desired sample size. For randomization of patients into two groups, we used balanced block method and then informed consent has been obtained from the patients
Blinding (investigator's opinion)
Double blinded
Blinding description
Physicians who do the injections, data collectors, data analyzer and outcome assessors are unaware of the type of injected medication to each patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research Vice-Chancellor for Research in Shahid Beheshti University o
Street address
Shahid Beheshti University of Medical Siences, Shahid Arabi Str, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.835

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain level
Timepoint
Before treatment, one month, three months and six months after the last injection
Method of measurement
En visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe)

2

Description
WOMAC Knee Score (Western Ontario & McMaster Universities Osteoarthritis Index )
Timepoint
Before treatment and three months after the last injection
Method of measurement
WOMAC Knee Score (Western Ontario & McMaster Universities Osteoarthritis Index ) Questionnaire

3

Description
Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint
Before the intervention and 3 months after the last injection
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Secondary outcomes

1

Description
Procedure side effects
Timepoint
1, 3, 6 months after the injection procedure
Method of measurement
Documentation of the name of complication based on the findings of Pain Fellowship observation

Intervention groups

1

Description
Intervention group: Intra-articular injection of IL-1RA group: In order to prepare IL-1RA, 50 ml of venous blood is taken from the patient using the Orthokine syringe (manufacturer country: Germany, the manufacturer: orthokine) containing glass beads coated with CrSO4. Then, to ensure complete mixing and maximal contact of beads and blood, the syringe is rotated gently and stored immediately at 37 ° C and transferred to an Orthogen lab within 24 hours in a deignated incubator. In the laboratory, a blood sample is tested for hepatitis A, B and HIV, and if any of the tests are positive, the test is repeated with a new blood sample. If the test is re-affirmed positive, the patient is excluded from the study. In the event of negative test results, the products of orthokine (IL-1RA) are prepared by the laboratory and returned to the hospital in 2-14 ml vials at -20 ° C within 14-21 days. The injection regime in Orthokine (IL-1RA) group consists of 6 injections, on days 0, 3, 7, 10, 14 and 21 days after the first injection, and is done by physician A.
Category
Treatment - Drugs

2

Description
Intervention group: intra-articular injection of hyaluronic acid group: . Two milliliters of Hyaluronic acid solution (1% Synocrom, manufacturer CROMA, Austria) is injected into the knee joint. These patients receive five injections by physician B at intervals of one week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Seyed Masoud Hashemi MD
Street address
Pain Clinic, Akhtar Hospital, Sharifi Manesh Str.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Fax
+98 21 2260 8246
Email
dr.hashemi@sbmu.ac.ir
Web page address
http://amc.sbmu.ac.ir/

2

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Seyed Masoud Hashemi MD
Street address
Velenjak, Arabi Str
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
dr.hashemi@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Seyed Masoud Hashemi MD
Street address
Tajrish Sqr, Shahrdari Str
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dr.hashemi@sbmu.ac.ir
Web page address
http://shmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi MD
Street address
Velenjak, Arabi Str, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Web page address
https://www.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
Seyed Masoud Hashemi MD.
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Email
dr.hashemi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Masoud Hashemi MD.
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Email
dr.hashemi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahid Beheshti University of Medical Sciences
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh st.
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2261 2252
Email
Dr.hashemi@sbmu.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
the access starts period 12 months after printing the results
To whom data/document is available
Researchers working in scientific and academic settings
Under which criteria data/document could be used
To perform further studies based on our study protocol
From where data/document is obtainable
Person responsible for scientific inquiries
What processes are involved for a request to access data/document
Sending Email
Comments
Loading...