Investigation the effect of autologous conditioned serum (Orthokine) injection into the disc and intervertebral foramen on low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine
Determining the effect of autologous conditioned serum (Orthokine) injection into the disc and intervertebral foramen on low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine
Design
Three arm randomised trial with a parallel group design of 30 patients, enrolled between September 2019 and March 2020
Settings and conduct
A total of 30 patients with radicular low back pain caused by lumbar disc herniation in the outpatient clinic of Imam Reza Hospital in Tabriz were enrolled. They are then randomly assigned to three groups of study. The first group was treated with intradisc injection of autologous conditioned serum, the second group was treated with foramenal injection of autologous conditioned serum. The third group (control) received oral analgesic (diclofenac) with rest. The analgesic drug is a type of NSAIDs (diclofenac), which will be adjusted according to the morphine table.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a herniated disc between the lumbar vertebra confirmed by a magnetic resonance imaging; low back pain score between 40 and 80 points on the 100-mm pain visual analogue scale
Exclusion criteria: bleeding disorders; drug addiction; drug sensitivity; psychopathy; history of surgery on spin; the lack of progressive motor weakness in the affected limb
Intervention groups
Group intervention 1: Intradisc injection of 2 milliliter autologous conditioned serum, three times a week apart in addition to oral pain relievers and rest
Group intervention 2: Foramenal injection of 2 milliliter autologous conditioned serum, three times a week apart in addition to oral pain relievers and rest.
Group intervention 3 (control): oral pain relievers (diclophenac) and rest
Main outcome variables
Low back pain intensity within the past week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043923N3
Registration date:2019-07-24, 1398/05/02
Registration timing:prospective
Last update:2019-07-24, 1398/05/02
Update count:0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
aghamohammadi.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of autologous conditioned serum (Orthokine) injection into the disc and intervertebral foramen on low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine
Public title
The effect of autologous conditioned serum on radiculopathy caused by herniated intervertebral disc
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a herniated disc between the lumbar vertebra confirmed by a magnetic resonance imaging
Low back pain score between 40 and 80 points on the 100-mm pain visual analogue scale
Exclusion criteria:
Bleeding disorders
Drug addiction
Drug sensitivity
Psychopathy
History of surgery on spin
The lack of progressive motor weakness in the affected limb
Age
From 19 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with block sizes of three and six and the allocation ratio of 1:1:1
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
3678965158
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.TBZMED.REC.1398.169
Health conditions studied
1
Description of health condition studied
Radioculopathy caused by lumbar disc herniation
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
Low back pain intensity within the past week
Timepoint
Pre-trial screening and at week 0 (baseline), 1, 2, 3 and 4 (follow-up sessions).
Method of measurement
100-mm visual analogue scale for low back pain
2
Description
Intensity of radiating pain in the lower extremities
Timepoint
Pre-trial screening and at week 0 (baseline), 1, 2, 3 and 4 (follow-up sessions).
Method of measurement
100-mm visual analogue scale for radiating pain
3
Description
Frequency of pain per day
Timepoint
Pre-trial screening and at week 0 (baseline), 1, 2, 3 and 4 (follow-up sessions).
Method of measurement
Self-reported
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intradisc injection of 2 milliliter autologous conditioned serum following the fluoroscopy procedure after the injection of a safe contrast agent and approved place, one injection per week for 3 consecutive injection in addition to oral rescue medication up to 2000 mg/day (four 500-mg tablets) and 5000 mg/week (10 tablets) of acetaminophen (500 mg/tablet, Alborz Darou. Co., Ltd., Tehran, Iran) if they feel severe pain (> 60 mm on the 100-mm visual analogue scale). To prepare the autologous conditioned serum, fifty milliliters of ' blood will be drawn from ante-cubital vein of the patients into a blood bag and be transferred to an autoclaved centrifuge tube without anticoagulants. Blood will be incubated aseptically at 37 °C for 24 hours. After incubation the tubes will be centrifuged at 3500 rpm for 10 minutes to retrieve the autologous conditioned serum. A clinical research coordinator will educate the participants in keeping a medication diary; he will also check the returned medications.
Category
Rehabilitation
2
Description
Intervention group 2: Foramenal injection of 2 milliliter autologous conditioned serum following the fluoroscopy procedure after the injection of a safe contrast agent and approved place, three times a week apart in addition to oral rescue medication up to 2000 mg/day (four 500-mg tablets) and 5000 mg/week (10 tablets) of acetaminophen (500 mg/tablet, Alborz Darou. Co., Ltd., Tehran, Iran) if they feel severe pain (> 60 mm on the 100-mm visual analogue scale). To prepare the autologous conditioned serum, fifty milliliters of ' blood will be drawn from ante-cubital vein of the patients into a blood bag and be transferred to an autoclaved centrifuge tube without anticoagulants. Blood will be incubated aseptically at 37 °C for 24 hours. After incubation the tubes will be centrifuged at 3500 rpm for 10 minutes to retrieve the autologous conditioned serum. A clinical research coordinator will educate the participants in keeping a medication diary; he will also check the returned medications.
Category
Rehabilitation
3
Description
Control group: Oral rescue medication up to 2000 mg/day (four 500-mg tablets) and 5000 mg/week (10 tablets) of acetaminophen (500 mg/tablet, Alborz Darou. Co., Ltd., Tehran, Iran) if they feel severe pain (> 60 mm on the 100-mm visual analogue scale). A clinical research coordinator will educate the participants in keeping a medication diary; he will also check the returned medications.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
6549832587
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
daghamohamadi@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available