Protocol summary

Study aim
The aim of this study is to compare the effects of ultrasound-guided injections of corticosteroid and Prolotherapy in the treatment of sacroiliac joint inflammation.
Design
A randomized (randomized blocking method), double blinded (patients and analyzers), clinical trial with a parallel group design of 40 patients referred to physical medicine and rehabilitation clinic at Firoozgar hospital, enrolled between 2015 and 2016, and followed for 8 weeks.
Settings and conduct
patients will be randomly divided to two groups of twenty. For randomization we will use randomized blocking method. The place of execution is physical medicine and rehabilitation clinic at Firoozgar hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of sacroiliac (Sl) joint pain, failure to respond to medication for one month, having a score of at least 4 in the Visual Analog Scale (VAS) criteria. Exclusion criteria: Malignancy, fractures, inflammatory arthritis, infections, fibromyalgia.
Intervention groups
After providing sterile conditions for injection, in one group, 2.5 ml containing 40 mg of triamcinolone and 2 cc of lidocaine and in other group, 2.5 cc of dextrose 20% and 2 cc of lidocaine, ultrasound-guided injected in the SIJ space. In both groups, physical therapy, including ROM exercises, stretching and isometric exercises will be taught to patients.
Main outcome variables
The severity of symptoms by Visual Analog Scale (VAS); The severity of symptoms and functional limitations in chronic low back pain by Dallas questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170910036107N2
Registration date: 2018-02-07, 1396/11/18
Registration timing: retrospective

Last update: 2018-02-07, 1396/11/18
Update count: 0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Naseh Yousefi
Name of organization / entity
Iran university of medical science and health services
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 6574
Email address
nasehusefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-07-25, 1396/05/03
Expected recruitment end date
2017-12-24, 1396/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of topical injection of dextrose and corticosteroids under ultrasound guidance in the treatment of sacroiliac joint inflammation, a Clinical trial
Public title
Effect of topical injection of dextrose and corticosteroids in treatment of sacroiliac joint inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of sacroiliac (Sl) joint pain Failure to respond to medication for one month Having a score of at least 4 in the Visual Analog Scale (VAS) criteria
Exclusion criteria:
Malignancy Fractures Inflammatory arthritis Infections Fibromyalgia
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: block, Unit of randomization: individual, Tools used in randomization such as table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study in which patients and outcomes analyzer are blinded. In order to blind the patient, it is said that both materials are effective for treatment, but the type of substance is not mentioned for patients when its injected. In order to blind the analyzer, the persons responsible for injection and data collection are different from the outcome assessors.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
1396.9411524009

Health conditions studied

1

Description of health condition studied
Inflammation of the sacroiliac joint
ICD-10 code
M46.1
ICD-10 code description
Sacroiliitis, not elsewhere classified

Primary outcomes

1

Description
The severity of symptoms
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Visual Analog Scale (VAS)

2

Description
The severity of symptoms and functional limitations in chronic low back pain.
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Dallas questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ultrasound-guided injection of Dexterose 20% in the SIJ space
Category
Treatment - Drugs

2

Description
Control group: Ultrasound-guided injection of corticosteroid in the SIJ space
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation,Firoozgar Hospital
Full name of responsible person
Gholam Reza Raissi
Street address
Firoozgar Hospital, Behafarin Avenue
City
Teharn
Province
Tehran
Postal code
0
Phone
+98 21 8214 1201
Email
nasehusefi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Mousavi
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway,
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 8214 1201
Email
nasehusefi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Neuromusculoskeletal Research Center
Full name of responsible person
Gholam Reza Raissi
Position
Associate professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square.
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 8214 1612
Fax
Email
graissi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neuromusculoskeletal Research Center, Iran University of Medical Sciences
Full name of responsible person
Tannaz Ahadi
Position
Associate professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square.
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 8214 1612
Fax
Email
tannaz.ahadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neuromusculoskeletal Research Center, Iran University of Medical Sciences
Full name of responsible person
Naseh Usefi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square.
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 8214 1612
Fax
Email
nasehusefi@gmail.com
Web page address

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 the patient's data can be shared with privacy in regard to patients name
When the data will become available and for how long
Start accessing 6 months after publishing the results.
To whom data/document is available
For scholars working in academic centers.
Under which criteria data/document could be used
It can be analyzed and printed by other people by mentioning the source.
From where data/document is obtainable
Dr. Naseh Yousefi, 989124261524, www.nasehusefi@gmail.com.
What processes are involved for a request to access data/document
Upon authentication, data is provided to the individual.
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