Protocol summary

Study aim
Evaluating the efficacy and safety of two methods of intra-articular injection and 4 injections at the joint level in the recovery of sacroiliac joint pain
Design
Clinical trial with two intervention groups, with parallel groups, double-blind, phase 2 on 40 patients, randomized
Settings and conduct
The place of study is the office of the supervisors and consultants (pain fellowship and endocrinology specialist), in the first group (20 people) intra-articular injection and in the second group (20 people) peri-articular injection (4 specific points around the joint) by a specialist doctor. will be The injected drug is the same in both groups. double blind (patient and researcher). Pain level of patients according to VAS scale (before injection, one hour after injection, one month after injection). Also, side effects are determined after the intervention.
Participants/Inclusion and exclusion criteria
Admission requirements: patients (ASA (American Society of Anesthesiologists) in class I and II, 18 years old and above, referred to the Yazd city pain clinic, who came with complaints of back pain and during clinical examinations, they had a clinical diagnosis of SIJ joint pain. Exclusion conditions: history of any uncontrolled medical disease - history of rheumatological or infectious diseases (RA, brucellosis)
Intervention groups
First group: intra-articular injection The second group: injection around the joint (4 specific points around the joint) The drug injected in both groups is the same, which includes a mixture of Hexal brand triamcinolone in the amount of 40 mg plus Myungmoon brand marcaine (bupivacaine) in the amount of 0-25% with a volume of 8cc, and the injection in both groups during the operation and the injection under guidance. Radiology (C-arm) will be performed by a specialist doctor.
Main outcome variables
pain intensity based on the VAS scale and side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210725051977N3
Registration date: 2023-01-15, 1401/10/25
Registration timing: prospective

Last update: 2023-01-15, 1401/10/25
Update count: 0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Masoud Khoshbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 9893
Email address
masoudkhoshbin@iauyazd.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the intra-articular injection versus quadruple injection at the joint surface in the treatment of sacroiliac joint pain
Public title
Comparison of the intra-articular injection versus quadruple injection at the joint surface in the treatment of sacroiliac joint pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA (American Society of Anesthesiologists) patients in class I and II, 18 years old and above, referred to Yazd city pain clinic, who came with complaints of back pain and during clinical examinations, they had a clinical diagnosis of SIJ joint pain.
Exclusion criteria:
History of any uncontrolled medical illness History of rheumatological or infectious diseases (RA, brucellosis)
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size of the study is 40 patients. The first patient who admitted to the office and meets the inclusion criteria will be No. 1 and the 40th patient will be No. 40. In advance, using the https://www.random.org, from the "List Randomizer" section of the website, the numbers 1 to 40 is randomly divided into two groups of 20 (the first twenty patients for the intra-articular injection group and the second 20 patients for the periarticular injection group). Example: Number 5 is in the intra-articular injection group in randomization of numbers 1 to 40, therefore, the fifth patient who meets the inclusion criteria will be in the intra-articular injection group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the patient are unaware of the grouping and what type of injection method (intra-joint or peri-joint) was performed. in such a way that the specialist doctor randomly selects each patient's group and Using the random numbers obtained from the List Randomizer website https://www.random.org, before referring to the operating room, he determines and performs the injection in the operating room without the presence of the researcher.Then 40 patients are given to the researcher to evaluate the severity of pain and complications after the injection.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd Islamic Azad University Medical School
Street address
Safaieh, Alam Square, Boulevard of the Shohadaie Gomnam, Ali Ibn Abitaleb Medical School
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.IAU.YAZD.REC.1401.062

Health conditions studied

1

Description of health condition studied
sacroiliac joint pain
ICD-10 code
S33.6
ICD-10 code description
Sprain of sacroiliac joint

Primary outcomes

1

Description
Pain intensity
Timepoint
Pain intensity of the patient at the beginning of the study (before the start of the intervention), one hour after the injection and 4 weeks after the injection
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

1

Description
Frequency of side effects in each group
Timepoint
one hour after the injection and 4 weeks after the injection
Method of measurement
check list including possible adverse (including injection site infection, pain aggravation, etc.)

Intervention groups

1

Description
Intervention group: Intra-articular injection Triamcinolone mixture of Hexal brand in the amount of 40 mgPlusMarcaine (bupivacaine) of Myungmoon brand is 0-25% with a volume of 8cc.
Category
Treatment - Drugs

2

Description
Intervention group: Intraoperative injection around the joint (4 specific points around the joint) Triamcinolone mixture of Hexal brand in the amount of 40 mgPlusMarcaine (bupivacaine) of Myungmoon brand is 0-25% with a volume of 8cc.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office of Dr Masoud Khoshbin - Pain fellow
Full name of responsible person
Dr Masoud Khoshbin
Street address
40th dead end, in front of Sepah, Shahid Sadoughi Boulevard, Yazd- Iran
City
Yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Fax
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ahmad Shajari
Street address
Safaieh, Alam Square, Ali Ibn Abitaleb Medical School
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 0540
Email
a_shajari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr Masoud Khoshbin
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd, Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
City
Yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Fax
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Masoud Khoshbin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd - Shahid Sadoughi Boulevard, in front of Sepah, 40th dead end
City
Yazd
Province
Yazd
Postal code
8917694784
Phone
+98 35 3138 0155
Email
masoudkhoshbin@iauyazd.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahverdi Sarasiabi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No.1,Corner HazratAbolfazl Alley, Wali Asr Mosque Alley, Daneshjo Blvd
City
Yazd
Province
Yazd
Postal code
8914818148
Phone
+98 913 723 9161
Email
Allahverdi.maryam88@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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