Evaluation of the effectiveness of of intra-articular sacroiliac injection in patients with sacroiliac pain
Design
Clinical trial without control group, phase 3 on 27 patients
Settings and conduct
This study is performed in Kashani Hospital in Isfahan. Selected patients treated with 10 mg solution of triamcinolone stanoid intra-sacroiliac joint under fluoroscopic guidance using needle 26. Patients' pain is measured by a questionnaire at 2, 4 weeks and 6 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 70-21 years, pain in the sacroiliac and lumbar joint, pain more than 6 months, at least 50% reduction in pain after 30 minutes of intra-articular diagnostic block with 0.5 ml of 2% lidocaine, consent Written to enter the study. Exclusion criteria: Existence of special conditions that are contraindicated for intra-articular injection, presence of diseases such as vertebral disc disease and vertebral disc herniation, radiculopathy, neuropathy, treatment with anticoagulants
Intervention groups
Intervention group: Patients in this group are treated with 10 mg solution of triamcinolone stanoid intra-sacroiliac joint under fluoroscopic guidance using needle # 26. Patients' pain is measured by a questionnaire at 2, 4 weeks and 6 months later.
Main outcome variables
Patients' back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N4
Registration date:2020-10-14, 1399/07/23
Registration timing:prospective
Last update:2020-10-14, 1399/07/23
Update count:0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-04, 1399/08/14
Expected recruitment end date
2020-11-14, 1399/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of of intra-articular sacroiliac injection in patients with sacroiliac pain
Public title
Corticosteroid injection into the sacroiliac joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 70-21 years
Pain in the sacroiliac and lumbar region
Pain for more than 6 months
Minimum 50% reduction in pain after 30 minutes of intra-articular diagnostic block with 0.5 ml of 2% lidocaine
Written consent to enter the study
Exclusion criteria:
There are special conditions that are contraindicated for intra-articular injection
Existence of diseases such as vertebral disc diseases and vertebral disc herniation
Radiculopathy
Neuropathy
Treatment with anticoagulants
Age
From 21 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2018-10-27, 1397/08/05
Ethics committee reference number
IR.MUI.MED.REC.1397.114
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
Timepoint
At 2, 4 weeks and 6 months after the intervention
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group are treated with 10 mg solution of triamcinolone stanoid intra-sacroiliac joint under fluoroscopic guidance using needle # 26. Patients' pain is measured by a questionnaire at 2, 4 weeks and 6 months later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Ali Andalib
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
ali_andelib@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Andalib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ali_andelib@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Andalib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ali_andelib@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Andalib
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ali_andelib@yahoo.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
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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.