Determination of the effect of low-dose naltrexone in comparison with guillotine on pain intensity in patients with TN and chronic migraine
Design
The placebo-controlled clinical trial is a single-blind, cross-over that randomly divides 40 patients into two groups by writing the numbers 1 to 40 on balls and placing them in a box. We will give and ask the patient to pick up a ball. If the ball removed by the patient was an odd number, the patient will be in the first group, and if the removed ball shows an even number, the patient will be in the second group. Finally, the ball is removed from the box by the patient and is no longer placed inside the box.
Settings and conduct
It will be performed in the oral and facial pains department of Kerman Dental School in 1401. It will last for eleven weeks for each patient as follows: base line (1 week), placebo (2 weeks) and low-dose naltrexone (8 weeks), the first week no capsule is prescribed as a base line and the patient is asked Will complete your daily report including the VAS form and most pain during the day.
Patients will be unaware that they are taking placebo or low-dose naltrexone while taking the drug.
Participants/Inclusion and exclusion criteria
1- According to ICHD3 criteria, they have been diagnosed with TN or chronic headache. 2- Be over 18 years old. 3- Have the necessary cooperation to participate in the study.
Intervention groups
Low-dose naltrexone and placebo to patients with chronic trigeminal neuralgia and migraine pain
Main outcome variables
The rate of recovery of chronic pain in patients; The extent of patients' pain during the day
Comparison of pain trends in patients with chronic trigeminal neuralgia and migraine over time in the two groups; Comparison of pain trends in patients with chronic trigeminal neuralgia and migraine over time in two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171109037332N2
Registration date:2022-04-19, 1401/01/30
Registration timing:prospective
Last update:2022-04-19, 1401/01/30
Update count:0
Registration date
2022-04-19, 1401/01/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32118022
Email address
h.kamyabi1244@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial on the efficacy of low dose naltrexone vs placebo on pain intensity in Trigeminal Neuralgia and Chronic migraine patients
Public title
Evaluation of the effect of low-dose naltrexone in patients with Trigeminal Neuralgia and Chronic migraine patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
According to ICHD3 criteria, they are diagnosed with TN or chronic headache.
Be over 18 years old
Have the necessary cooperation to participate in the study.
Exclusion criteria:
Patient non-cooperation
The patient is pregnant or breastfeeding.
If the patient uses opioid analgesics or inhales opioids
If the patient regularly uses anti-inflammatory drugs.
Known allergy or reaction to naltrexone
If the patient consumes alcohol and can not refrain from consuming it during the study.
The patient has rheumatic or autoimmune diseases
The patient has been diagnosed with a mental illness that disrupts his or her collaboration in the study.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups by placing the numbers 1 to 40 on the balls and placing them in a box and asking the patient to pick up a ball. If the ball removed by the patient was an odd number, the patient will be in the first group, and if the removed ball shows an even number, the patient will be in the second group. Finally, the ball is removed from the box by the patient and is no longer placed inside the box.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients are blinded to the period they are taking placebo or medication.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Before the intervention and every day during the intervention
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: First two weeks of placebo and then eight weeks of low-dose naltrexalone (4.5 mg) will be given. In the low-dose placebo and naltrexalone phases, the capsules are taken orally daily and the daily symptoms, including the VAS form (zero to 100) and the most pain during the day, will be collected. Low-dose naltrexalone (4.5 mg naltrexone hydrochloride) (co-containing) and placebo alike using standard gelatin capsules and a microcrystalline cellulose filler (Avicel, FMC BioPolymer, Rockland, ME) and a calorie-free sweetener ( Will be prepared by a pharmacist). Participants take the capsules (LDN and placebo) once a day for 10 weeks and approximately 1 hour before bedtime (two weeks of placebo capsules and eight weeks of LDN capsules). Patients will be called to the clinic every two weeks to visit and check for their daily symptoms.
Category
Other
2
Description
Intervention group 2: first eight weeks of low-dose naltrexalone (4.5 mg) and then two weeks of placebo. In the low-dose placebo and naltrexalone phases, the capsules are taken orally daily and the daily symptoms, including the VAS form (zero to 100) and the most pain during the day, will be collected. Low-dose naltrexalone (4.5 mg naltrexone hydrochloride) (co-containing) and placebo alike using standard gelatin capsules and a microcrystalline cellulose filler (Avicel, FMC BioPolymer, Rockland, ME) and a calorie-free sweetener ( Will be prepared by a pharmacist). Participants take the capsules (LDN and placebo) once a day for 10 weeks and approximately 1 hour before bedtime (two weeks of placebo capsules and eight weeks of LDN capsules). Patients will be called to the clinic every two weeks to visit and check for their daily symptoms.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and facial pain department of Kerman Dental School
Full name of responsible person
Goli Chamani
Street address
Kerman school of dentistry, Shafa Ave.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
h.kamyabi1244@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Jahad Blvd. Ebn Sina Avenue
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 4251
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
Homa Kamyabi
Position
Non-faculty Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shafa St., School of Dentistry
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9028
Fax
Email
h.kamyabi1244@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Goli Chamani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa St., Faculty of Dentistry
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9028
Fax
Email
h.kamyabi1244@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Homa Kamyabi
Position
Non-faculty Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shafa St., Faculty of Dentistry
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9028
Fax
Email
h.kamyabi1244@gmail.com
Web page address
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
Data files entitled "Evaluation of the effect of low-dose naltrexone and placebo on pain intensity in patients with trigeminal neuralgia and refractory migraine after potentially unidentifiable individuals are shared"
When the data will become available and for how long
Start access 6 months after publishing results
To whom data/document is available
The data file can be requested and received by all people, whether working in academia or in industry.
Under which criteria data/document could be used
After requesting and receiving the data file, applicants are allowed to make any use of the documents if asked and allowed by researchers.Individuals can request documentation by email and no conditions are required for their receipt.
From where data/document is obtainable
Individuals can request data documentation by email to Dr. Goli Chamani (golichamani@yahoo.com).
What processes are involved for a request to access data/document
Individuals can email Dr. Goli Chamani (the first person in the article) 6 months after the publication of the results to access the data and documents, and about 1 month later the documents and data will be sent to them.