Evaluation of the effect of autologous conditioned serum (Orthokine) injection into the oval foramen in pain control in trigeminal neuralgia patients: a pilot study
Determination of the effect of autologous conditioned serum (Orthokine) injection into the Foramen ovale in controlling pain of trigeminal neuralgia patients
Design
One-armed open trial
Settings and conduct
A total of 10 patients with idiopathic trigeminal neuralgia will be enrolled in the palliative outpatient clinic of Emam Reza Hospital in Tabriz and will be treated with the Fluoroscopic guided injection of 2 milliliter autologous conditioned serum into the foramen ovale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of idiopathic trigeminal neuralgia; complaining of severe pain refractory to oral medications
Exclusion criteria: bleeding disorders; drug addiction; drug sensitivity; psychopathy
Intervention groups
Intervention: Injection of 2 milliliter autologous conditioned serum in to foramen oval, three times a week apart
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043923N1
Registration date:2019-06-29, 1398/04/08
Registration timing:prospective
Last update:2019-06-29, 1398/04/08
Update count:0
Registration date
2019-06-29, 1398/04/08
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of autologous conditioned serum (Orthokine) injection into the oval foramen in pain control in trigeminal neuralgia patients: a pilot study
Public title
The effect of autologous conditioned serum (Orthokine) in the treatment of trigeminal neuralgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of idiopathic trigeminal neuralgia
Complaining of severe pain refractory to oral medications
Exclusion criteria:
Bleeding disorders
Drug addiction
Drug sensitivity
Psychopathy
Age
From 19 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
6987598632
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.TBZMED.REC.1398.170
Health conditions studied
1
Description of health condition studied
Trigeminal neuralgia
ICD-10 code
G50.0
ICD-10 code description
Trigeminal neuralgia
Primary outcomes
1
Description
Pain intensity
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the onset of the course of treatment
Method of measurement
Verbal rating scale ranges from 0 (no pain) to 10 (maximal pain)
2
Description
Pain duration
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the onset of the course of treatment
Method of measurement
Self-declaration
3
Description
Pain daily frequency
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21 and 28 days after the onset of the course of treatment
Method of measurement
Self-declaration
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 2 milliliter autologous conditioned serum into the foramen ovale following the fluoroscopy procedure after the injection of a safe contrast agent and approved place, three times a week apart. 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.
Category
Treatment - Other
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
3659875698
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