Comparison of transforaminal epidural Autologous Conditioned Serum (ACS) and triamcinolone on pain and disability in patients with unilateral lumbar radicalular pain
The effects of Autologous Conditioned Serum therapy on unilateral lumbar radicular pain.
Design
Clinical trial with two experimental groups with parallel groups, double-blind, randomized, phase 3 in 64 patients.
Settings and conduct
The study is performed in Akhtar Hospital (Shahid Beheshti University of Medical Sciences). After recording the pain intensity, the patients are randomly divided into intervention and control groups, and after injecting the drug in the desired area, the pain and disability are assessed.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 64 years with low back pain and spread to a lower limb will take part in this study. The exclusion criteria are spinal canal stenosis, previous lumbar surgery, and systemic disease.
Intervention groups
Under fluoroscopic guidance in the prone position, through transforaminal epidural approach, 3 cc lidocaine 1% plus 40 mg triamcinolone will be injected in the experimental group 1 (triamcinolone group) and 4 cc Autologous Conditioned Serum (ACS) will be injected in the experimental group 2 (ACS group).
Main outcome variables
Assessment of pain intensity using the Visual Analogue Scale (VAS); assessment of disability using the Oswestry Disability Index (ODI).
General information
Reason for update
Acronym
Autologous Conditioned Serum (ACS)
IRCT registration information
IRCT registration number:IRCT20190513043580N1
Registration date:2020-08-17, 1399/05/27
Registration timing:retrospective
Last update:2020-08-17, 1399/05/27
Update count:0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Sarah Hojjati
Name of organization / entity
Shiraz Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 71 3621 5680
Email address
sarah_hojjati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2020-03-14, 1398/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of transforaminal epidural Autologous Conditioned Serum (ACS) and triamcinolone on pain and disability in patients with unilateral lumbar radicalular pain
Public title
The Effect of Transforaminal epidural Autologous Conditioned Serum (ACS) in lumbar pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have 6 weeks of moderate to severe low back pain confirmed by magnetic resonance imaging and have no response to conservative treatments.
Exclusion criteria:
Have a spinal canal stenosis
Have a systemic bone or joint disease
Have systemic inflammatory diseases
Previous history of lumbar surgery
Concurrent cervical myelopathy
Altered coagulation
Ongoing infectious disease
Have steroid injections over the past 6 months
Presence of neurological deficits
Need of early surgery
Have an acute trauma
Pregnancy
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization process will be done by assigning code to patients and putting them in the sealed envelope and randomly selecting them.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient evaluators, nurses, and outcome analyzers will not be aware of the type of patient groups until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti university of medical sciences, Koodakyar str, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-07-18, 1398/04/27
Ethics committee reference number
IR.SBMU.REC.1398.034
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before intervention , 3 weeks, 3 , and 6 months after intervention.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group 1: The patient is placed in a prone position in the operating room. Transformaminal epidural space is determined by X-ray (fluoroscopy) and a spinal needle enters the space. After confirmation with contrast material, 40 mg triamcinolone with 3 cc 1% lidocaine (Elixir Pharmaceutical Company, Iran) is injected.
Category
Treatment - Drugs
2
Description
Experimental group 1: The patient is placed in a prone position in the operating room. Transformaminal epidural space is determined by X-ray (fluoroscopy) and a spinal needle enters the space. After confirmation with contrast material, 4 cc Autologous Conditioned Serum (ACS ) (Orthokin , Germany) is injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Seyed Masoud Hashemi
Street address
Akhtar Hospital, Shariati Str
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
siteAkhtar@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti of Medical Sciences, Koodakyar str, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Salman Vojdani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Beheshti of Medical Sciences, Koodakyar str, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1920
Email
vojdansalman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hashemi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akhtar Hospital, Sharifi Manesh Str, Elahieh
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
Hashemimasoud@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sarah Hojjati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University of Shiraz Branch, Sadra Town
City
Shiraz
Province
Fars
Postal code
74731-71987
Phone
009871361919
Email
Sarah_hojjati@yahoo.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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol, statistical analysis, and consent form will be provided to those interested in the article that will eventually be published.
When the data will become available and for how long
Immediately after printed article.
To whom data/document is available
All researchers will have access to the information provided in the article.
Under which criteria data/document could be used
For use in future research or in the treatment of patients.
From where data/document is obtainable
Dr Masoud Hashemi, Akhtar Hospital, Sharifi Manesh Str, Tehran.
What processes are involved for a request to access data/document
The applier of the data file should send an email to the researcher. The researcher will inform the applier after the consent of other researchers, and this process will take a maximum of 3 weeks.