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Study the effect of Ultrasound-Guided Sacroiliac joint single dose platelet-rich plasma injection in patients with sacroiliac joint pain. A, single-arm, before and after, open-label clinical trial

Protocol summary

Study aim
To determine the effect of platelet-rich plasma injection under ultrasound guidance on pain intensity and functional improvement in patients with sacroiliac joint pain.
Design
It is a Phase 2, single-arm clinical trial in which a single dose of platelet-rich plasma is injected into the sacroiliac joint under ultrasound guidance in 26 patients with sacroiliac joint pain.
Settings and conduct
This study is conducted in the pain clinics of Imam Khomeini Hospital in Tehran, on patients with sacroiliac joint pain. Provocative tests and MRI are performed for the absence of the joint inflammation. If three tests are positive and MRI is normal, sacroiliac joint disorder is diagnosed. Patients with chronic pain and NRS above 5 who have not responded to drug treatments are enrolled. To prepare PRP, blood is taken from the cubital vein and CPD-A1 is added. Two centrifugations are performed to concentrate the platelets. All procedures are performed in the operating room under proper monitoring. The patient is placed in a suitable position and 10 cc of peri-articular PRP is injected. Patients are evaluated one and three months later in terms of pain intensity (NRS) and function (ODI)
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 20-60 with sacroiliac joint pain, NRS >5 in the last 3 months, based on clinical exams and positive results from 3 provocative tests. Exclusion Criteria: Thrombocytopenia, local infection at injection site, NSAIDs within 48 hours before injection, systemic corticosteroids within 1 month before injection, malignancy, pregnancy, rheumatological diseases, uncontrolled hormonal disorders, systemic inflammatory diseases, neurological/psychological disorders, midline pain above L5 level.
Intervention groups
platelet-rich plasma injection
Main outcome variables
Pain Intensity: Measured using the NRS Functional Improvement: Evaluated using the ODI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141023019640N4
Registration date: 2024-09-01, 1403/06/11
Registration timing: prospective

Last update: 2024-09-01, 1403/06/11
Update count: 0
Registration date
2024-09-01, 1403/06/11
Registrant information
Name
Hossein Majedi Ardakani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 4084
Email address
hmajedi@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-18, 1403/06/28
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Ultrasound-Guided Sacroiliac joint single dose platelet-rich plasma injection in patients with sacroiliac joint pain. A, single-arm, before and after, open-label clinical trial
Public title
Study the effect of Ultrasound-Guided Sacroiliac joint single dose platelet-rich plasma injection in patients with sacroiliac joint pain. A, single-arm, before and after, open-label clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20-60 years with sacroiliac joint pain and an NRS (Numeric Rating Scale) score greater than 5 during the last three months, based on clinical examinations and positive results of three sacroiliac joint provocative tests (Faber, Gaenslen, iliac compression, Fortin Finger, Yeoman, thigh thrust, iliac distraction), will be included in the study.
Exclusion criteria:
Thrombocytopenia (platelets less than 150,000 per microliter), local infection at the injection site, use of non-steroidal anti-inflammatory drugs within 48 hours before injection, use of systemic corticosteroids within a month before injection, malignancy, pregnancy, rheumatological diseases, Uncontrolled hormonal disorders, systemic inflammatory diseases, neurological or psychological disorders, age less than 20 years or more than 60 years, patients with midline pain above the level of the fifth lumbar vertebra.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Pain research Center, Neuroscience Institute, Imam Khomeini Hospital Complex, Dr. Gharib street
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
IR.TUMS.NI.REC.1402.060

Health conditions studied

1

Description of health condition studied
Sacroiliac joint pain
ICD-10 code
G89.2
ICD-10 code description
Chronic pain, not elsewhere classified

Primary outcomes

1

Description
Pain Intensity
Timepoint
The patient's pain intensity is measured before the intervention and at one and three months after the intervention (PRP injection into the sacroiliac joint).
Method of measurement
Numeric Rating Scale (NRS)

Secondary outcomes

1

Description
Functionality
Timepoint
The patient's functional improvement is measured before the intervention and at one and three months after the intervention (PRP injection into the sacroiliac joint)
Method of measurement
Oswestry Disability Index (ODI)

Intervention groups

1

Description
Intervention group: PRP injection (Royagen kits, made by Aria Mobna Diagnos Company) is performed as a single dose with a volume of 10 cc.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pain clinics of Imam Khomeini Hospital in Tehran
Full name of responsible person
Dr. Hossein Majedi Ardakani
Street address
Pain research center, neurosciences institute ,Imam Khomeini Hospital Complex , Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1627
Email
hmajedi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
Keshavarz Blvd., corner of Qods St., Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Majedi Ardakani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Pain research center, Neuroscience institute, Imam Khomeini Hospital Complex, Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1627
Email
hmajedi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Majedi Ardakani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Pain research center, Neurosciences institute, Imam Khomeini Hospital Complex, Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1627
Email
hmajedi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Majedi Ardakani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Pain research center, Neurosciences institute, Imam Khomeini Hospital Complex, Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1627
Email
hmajedi@tums.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
No - There is not a plan to make this available
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