Ivestigation Efficacy of Intradiscal Injection of Radiopaque Gelified Ethanol in Treatment of lumbar and cervical radiculopathy patients
Design
This phase 2 clinical trial is conducted on two parallel groups without a control group, blinding, and randomization on patients with lumbar or cervical radiculopathy. Patients are evaluated in terms of pain level and functional status in daily life before the intervention of RGE injection. After the intervention, 1 and 3 months after the injection, they are again evaluated for pain and function. Then these findings are compared with the findings before the injection. This study was neither blinded nor randomized.
Settings and conduct
In this study patients with lumbar or cervical radiculopathy are evaluated. This study will be carried out in Imam Hossein Hospital. Blinding was not done. amount of pain and functional status evaluation before, 1, and 3 months after the intervention is done via questionnaire. the treatment response is evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
consent to participate
spinal canal stenosis of less than 30% in MRI findings
no history of spinal deformities
Exclusion criteria:
Unexpected allergy to antiseptic agents
Unexpected allergy to local anesthetics
Unexpected allergy to intravenous sedatives
Intervention groups
For patients in each of the intervention groups, under the precise guidance of the fluoroscope, one dose of radiopaque gellified ethanol with the appropriate dose (lumbar disc 0.8ml and cervical 0.2ml) is injected into the nucleus of the discs.
Main outcome variables
Pain level of patients via the NRS-11 questionnaire, functional status of patients with low back pain via ODI questionnaire, and functional status of patients with neck pain are evaluated vvia NDI questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240416061509N1
Registration date:2024-06-03, 1403/03/14
Registration timing:prospective
Last update:2024-06-03, 1403/03/14
Update count:0
Registration date
2024-06-03, 1403/03/14
Registrant information
Name
Abdolsamad Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3439 4395
Email address
amiri.samad55@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intradiscal injection of Radiopaque Gelified Ethanol (RGE) in Treatment of lumbar and cervical radiculopathy patients
Public title
Efficacy of intradiscal injection of Radiopaque Gelified Ethanol (RGE) in Treatment of lumbar and cervical radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
those suffering from disc herniation of grade I or II
patients who have given their consent to participate
individuals aged 18 years and older
people experiencing symptoms of chronic lumbar and cervical radiculopathy for a duration exceeding six months
non-opioid use
coagulation disorders
spinal canal stenosis less than 30%
Exclusion criteria:
individuals with degenerative disc disease
recent RGE injection in 6 month ago
pregnancy
malignancy or psychiatric problems
participants have any history of spinal deformity or surgery
participants have any history trauma, or vertebral fracture
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shahid beheshti medical of sciences university
Street address
imam-hosein square- shahid madani steet
City
tehran
Province
Tehran
Postal code
1617763141
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.894
Health conditions studied
1
Description of health condition studied
lumbar and cervical radiculopathy
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
pian in of lumbar and cervical radiculopathy patients
Timepoint
the amount of pain will chek before injection, one month and three months after injection by reliable pain mesurement.
Method of measurement
the amount of pain will chek by three tool Oswestry Disability Index (ODI) - numeric rating scale (NRS) -Neck Disability Index (NDI).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients with cervical radiculopathy resistant to conservative management will be treated with Vista Salamat Tetis' radiopaque gellified ethanol, Absolute-Gel, at a dose of 0.2ml. A single injection of the drug will be administered under precise fluoroscopic guidance into the nucleus of the cervical disc.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients with lumbar radiculopathy resistant to conservative management will be treated with Vista Salamat Tetis' radiopaque gellified ethanol, Absolute-Gel, at a dose of 0.8ml. A single injection of the drug will be administered under precise fluoroscopic guidance into the nucleus of the lumbar disc.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-hossien hospital
Full name of responsible person
Abdolsamad Amiri
Street address
Imam-hossein squar - shahid madani street
City
Tehran
Province
Tehran
Postal code
3616951835
Phone
+98 21 3234 2000
Email
amiri.samad55@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud hashemi
Street address
District 1, Daneshjou Blvd
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
amiri.samad55@gmail.com
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
Abdolsamad amiri
Position
fellowship of pain management
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
ashrafi-esfahani dis - fakori street - no 28
City
tehran
Province
Tehran
Postal code
1477659556
Phone
+98 21 4922 0350
Email
amiri.samad55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud hashemi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Tehran Province, Tajrish, Shariati St
City
tehran
Province
Tehran
Postal code
1477659856
Phone
+98 21 2665 8517
Email
hashemimasoud@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sina hassannasab
Position
fellowship of pain management
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam-hosien hospital
City
tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 3000
Email
sina.hsn@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about patients after making them unidentifiable and information about the main outcome and results of the study
When the data will become available and for how long
The access period starts from September 2024
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
If the reference is mentioned, the results of this study can be published in other scientific sources.
From where data/document is obtainable
To Dr. AbdolSamad Amiri working at the Pain departmant of Imam Hossein Hospital in Tehran
What processes are involved for a request to access data/document
Documents can be received through the registered e-mails on the website.
amiri.samad55@gmail.com