Comparison of the Effectiveness of Platelet-Rich Plasma (PRP) Therapy with Steroid Therapy in Improving the Clinical Symptoms of Patients with Rheumatoid Arthritis.
Evaluation of the efficacy of Platelet-Rich Plasma (PRP) therapy in Rheumatoid arthritis Patients.
Design
A clinical trial with a control group, parallel-group randomized trial with blinded outcome assessment, phase 3 on 40 patients.
Settings and conduct
The study will be conducted at the Autoimmune Diseases Research Center of Shiraz University of Medical Sciences.
Drug prescription and therapeutic intervention will be done in the rheumatology department of Hafez Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with rheumatoid arthritis.
Exclusion criteria: patients who are being treated or suffering from other autoimmune diseases.
Intervention groups
The control group is Rheumatoid arthritis patients treated with standard steroid medicine.
The experimental group is Rheumatoid arthritis Patients who are treated with platelet-rich plasma.
Main outcome variables
1. Determination of Erythrocyte Sedimentation Rate, C-Reactive Protein, Anti Citrullinated peptide Antibody, Antinuclear Antibodies, and Rheumatoid Factor serum levels in patients before and after Platelet-Rich Plasma therapy.
2. Evaluation of Interleukin 1 beta synovial fluid levels in patients before and after Platelet-Rich Plasma therapy.
3. Evaluation of radiological examination in Rheumatoid Arthritis patients before and after Platelet-Rich Plasma therapy.
4. Evaluation of synovial fluid cell counts in Rheumatoid Arthritis patients before and after Platelet-Rich Plasma therapy.
5. Calculation of Disease Activity Score-28 in Rheumatoid Arthritis patients before and after Platelet-Rich Plasma therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221203056694N1
Registration date:2023-01-28, 1401/11/08
Registration timing:registered_while_recruiting
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Nasser Gholijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3208 4176
Email address
gholijanin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Platelet-Rich Plasma (PRP) Therapy with Steroid Therapy in Improving the Clinical Symptoms of Patients with Rheumatoid Arthritis.
Public title
Effect of platelet-rich plasma therapy in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
This study will be done on 40 patients with RA diseases who were diagnosed at the rheumatology clinic of Hafez Hospital, according to the American College of Rheumatology/European League Against Rheumatism criteria.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization methods:
The method of simple random assignment is that odd numbers are given to the intervention group (platelet-rich plasma prescription) and even numbers are given to the control group (common treatment with triamcinolone prescription). Then, according to the number of the studied sample, the relevant numbers are extracted from the table of random numbers or using a computer, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope. And the first patient who is registered in the study and enters the study will be given the envelope related to patient number 1, patient number 2 will be given envelope number 2 and so on, this work will continue until the end of the study sample. The person who prepares the envelopes will be different from the person who registers the patients and provides the envelopes to the patients. Considering that the treatment allocation of patients is done by the doctor, in order to prevent the influence of the doctor's opinion, the registration of the patients and their allocation in each of the groups will be done by the doctor's assistant and someone other than the doctor.
Blinding (investigator's opinion)
Double blinded
Blinding description
In our study, the investigator, the physician evaluating the treatment, those responsible for data collection, and those evaluating the outcome are blinded.
In this study, in order to avoid applying the personal opinion of the doctor evaluating the course of treatment, he/she will be unaware of the type of treatment received in each of the research subjects, and it is important to note that during the stages of the research, due to the patient's contact with the doctor, blinding will not disappear. Those responsible for data collection should be unaware of the type of treatment received by the people participating in the research. Those who evaluate the results are chosen outside the treatment team so that even if the researcher knows the type of intervention assigned to the participants in the research, their knowledge does not affect the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.SUMS.REC.1398.596
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis (RA)
ICD-10 code
M06
ICD-10 code description
Other rheumatoid arthritis
Primary outcomes
1
Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
Westergren method
2
Description
C-reactive protein (CRP)
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
ELISA
3
Description
Anti Citrullinated peptide Antibody
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
ELISA
4
Description
Antinuclear Antibody (ANA)
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
ELISA
5
Description
Rheumatoid Arthritis (RA) factor
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
ELISA
6
Description
Interleukin-1 beta
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
ELISA
7
Description
Radiological Examination
Timepoint
Before and after Platelet-rich plasma (PRP) therapy
Method of measurement
Radiology
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient’s own platelets to accelerate the healing of injured tendons, ligaments, and joints. To prepare 4–5 cc PRP, 30–40 cc venous blood samples from the antecubital vein will be collected in a sterile acid citrate dextrose tube using an 18G needle to avoid traumatizing platelets. Then, the blood with anticoagulant will be centrifuged twice: First, we will centrifuge the blood at 1,800 rpm for 15 minutes to separate erythrocytes and Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Then the tube will be centrifuged at 3,500 rpm for 5 minutes to concentrate platelets. The lower 1/3rd is PRP and the upper 2/3rd is platelet-poor plasma (PPP). PPP will be removed and platelet pellets will be suspended in a minimum quantity of plasma (2-4 mL) by gently shaking the tube. The final product is 4–5 cc of PRP-containing leukocytes. Approximately 0.5 cc PRP will be collected for platelet counting. Finally, 0.0425 mL of 10% calcium chloride per 1 mL of PRP will be added to the final product to activate the platelets.PRP in a sterile condition will be injected by a physician using a classic lateral approach with a 22 G needle with the subjects in a supine position with the knee in full extension. The second injection will be administered under the same conditions as the first injection., three months later. During the follow-up period, the patients will be asked to take acetaminophen only when necessary, or acetaminophen with codeine for persistent pain. The patients will be instructed not to take drugs in the 48 hours before an assessment. Patients will be prohibited from using other analgesics, NSAIDs, steroids, or medications which might have influenced platelet count or function. Exercise or physical treatment will not be allowed during the study period to eliminate synergistic effects. Patients will be evaluated before the treatment and the 3 months after the treatment with a clinical laboratory exam and radiological examination. A radiological examination of the knee is performed before and at the end of the study.
Category
Treatment - Other
2
Description
Control group: Prescribing conventional steroid drugs in the treatment of rheumatoid arthritis. Patients in this group will take intra-articular injections of triamcinolone, 80 mg, at the beginning of the study and three months later. Frequency of patients’ evaluations: History taking, physical examination {including assessment of VAS (visual analog scale 0-10) for joint pain at rest (VASR), VAS for joint pain at motion (VASM), and VAS for joint swelling (VASSw) at baseline, and months three. Blood sampling will be performed at baseline and in months three. Inflammatory cytokines will be checked at baseline and at the end of the study. Synovial fluid sampling will be performed at each time intra-articular injection. Radiographs will be taken at the baseline and the end of the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital, Rheumatology Department
Full name of responsible person
Mohammad Ali Nazarinia
Street address
Hafez Hospital, Chamran St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۳۴۷۸۶- ۷۱۹۴۶
Phone
+98 71 3647 9531
Email
nazariniam@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Memarpour Mahtab
Street address
7th Floor, Administration Building of Shiraz University of Medical Sciences, Office of the Vice-Chancellor for Research and Technology, Shiraz University of Medical Sciences, Zand Ave., Shiraz, IRAN
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shiraz University of Medical Sciences
Full name of responsible person
Nasser Gholijani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Autoimmune Diseases Research Center- Shiraz School of Medicine, Imam Hossein Square Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3208 4176
Fax
Email
gholijanin@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasser Gholijani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Autoimmune Diseases Research Center- Shiraz School of Medicine, Imam Hossein Square Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3208 4176
Fax
Email
gholijanin@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasser Gholijani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Autoimmune Diseases Research Center- Shiraz School of Medicine, Imam Hossein Square Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3208 4176
Fax
Email
gholijanin@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD