The effect of PRP in the treatment of patients with chronic pain caused by based discopathy
Design
Clinical trial with control group, Non-random, with parallel groups, one-way blind, phase 2 on 40 patients.
Settings and conduct
In the field of disc-related pain, Bahonar Hospital of Kerman, patients after dividing into two groups will have both the same treatment methods and only in the second group PRP will be placed in disk space at the end of treatment. People who check the rate of pain changes and MRI, as well as the person who analyzes the results, will not be aware of how people divided into groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged between 20 and 60 years; Patients with chronic low back pain caused by discopathy for more than 6 months; Failure in common medical treatments used; Damaged disc, annular rupture or disc removed on radiography; The patient's disc should be one level
Exclusion criteria: Existence of bleeding disorder; Pregnancy; Local or systemic infection; Existence of a medical or psychological condition; Drug use
Intervention groups
The first group will receive routine treatment without PRP.
The second group will receive routine treatment with PRP.
Main outcome variables
Change in pain; Change in MRI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210128050164N1
Registration date:2021-02-18, 1399/11/30
Registration timing:prospective
Last update:2021-02-18, 1399/11/30
Update count:0
Registration date
2021-02-18, 1399/11/30
Registrant information
Name
Vahid Tavakolian Ferdousie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3272 2658
Email address
tavakolian.v@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Platelet-Rich Plasma (PRP) in treatment of patients with lumbar discogenic pain
Public title
Effect of platelet-rich plasma on discopathic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 20 and 60 years
Patients with chronic low back pain caused by discopathy for more than 6 months
Failure in commonly used medical treatments
Damaged disc, annular rupture, or disc removed on radiograph
The patient disk should be one level.
Exclusion criteria:
Existence of bleeding disorder
Pregnancy
Local or systemic infection
Existence of a medical or psychological condition
Narcotics Use
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
A person who monitors the amount of pain and disc changes on MRI will not know which group the person is in.
Also, the person who analyzes the information will not know which group the people are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman, the beginning of Haft Bagh Alavi Blvd, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.KMU.REC.1399.583
Health conditions studied
1
Description of health condition studied
lumbar discogenic pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
1 day, 1 week, 1 month, 6 months, 12 months, 18 months and 24 months after intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Disc changes on MRI
Timepoint
Three months before surgery,12 months and 24 months after intervention
Method of measurement
Pfirrmann scoring system
Intervention groups
1
Description
Intervention group: After the test description and written consent from the patient, about 20 cc of blood on ACD anticoagulant will be taken from the patient and immediately transferred to the laboratory. In the laboratory, a blood sample will be centrifuged and platelet-rich plasma (PRP) will be separated and prepared and given to a physician for injection.
Category
Treatment - Drugs
2
Description
Control group: In this group, only routine treatments will be performed and there will be no additional treatment or medication.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Mehdi Ahmadi Nejad
Street address
Qarni St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mahmadinejad @kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Vahid Tavakolian ferdousie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Email
Tavakolian.v@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohsen Shahba
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Kerman, Qarni St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
msneurosurgern@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
vahid Tavakolian Ferdousie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Qarni St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Tavakolian.v@gamil.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
Age, gender, PRP preparation method, surgery method
When the data will become available and for how long
Access period starts one year after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
To do this on more people or to use stem cells using this research
From where data/document is obtainable
Dr. Mohsen Shahba; msneurosurgeon@gmail.com; 00989134419232
What processes are involved for a request to access data/document
It takes a month for documents or data files to reach the individual.