Comparing The Analgesic Effect Of Agomelatin Versus Placebo In Combination With Pregabalin In Patients With Chronic Low Back Pain : A Randomized , Double-Blinded Study
Evaluating the effectiveness of Agomelatin in chronic low back pain and the effectiveness in disabilty nad depression caused by chronic low back pain
Design
The patients aged between 18 to 60 after complete description and taking the informed consent will enter this study and with the usage of randomization and Balanced Block RAndomization , they will divide into 2 groups(first group taking Pregabalin75 mg BD + Placebo Daily and the second group taking Pregabalin 75mg BD + Agomelatin25mg daily)
Before taking Agomelatin and in the third week of its usage the liver enzymes will be checked.They will be evauated in 0 , 1,4,8 week .the 1st week will be by phone.in the 4th and 8th week they will answer the questionnaire .The lab data will be checkd in 4th week.
Settings and conduct
Rasoul akram Hospital
Participants/Inclusion and exclusion criteria
Patients with chronic low back pain without an indication for surgery.Chronic low back pain+patients with low back pain for at least 3 months(almost everyday)
Patients aged between 18 to 60
Intervention groups
Intervention group : taking pregabalin + agomelatin
Control group : taking pregabalin + placebo
Main outcome variables
severity of pain before and after taking Pregabalin ; Severity of pain before and after taking agomelatin ; severity of disability before and after taking Pregabalin ; Severity of pain before and after taking Agomelatin ; Severity of depression and anxiety before and after taking Agomelatin ; Severity of pain before and after taking Pregabalin; severity of depression and anxiety before and after taking pregabalin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047852N1
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Shayan Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 3375
Email address
amiri.shayan23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-06, 1399/04/16
Expected recruitment end date
2020-10-07, 1399/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Analgesic Effect Of Agomelatin Versus Placebo In Combination With Pregabalin In Patients With Chronic Low Back Pain : A Randomized , Double-Blinded Study
Public title
"Agomelatin in chronic low back pain"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic low back pain without an indication for surgery.Chronic low back pain+patients with low back pain for at least 3 months(almost everyday)
Patients aged between 18 to 60
Exclusion criteria:
Patiens with long term usage of Opioids , Anti depressants , Benzodiazepines,Gabaergic drugs
Any contraindications for using each drugs(Agomelatin or Pregabalin)
Liver enzymes three times more than normal
Patients with depression disorder or suicidal thoughts or psychosis or acute manic phase or cognitive disorder or anxiety disorder or PTSD who needs treatment. These patients will exclude by an interview done by an educated psycholoy resident due to DSM5
Patients who need surgery will exclude
PAtients who are taling any Anti-depressants drugs
Patients who took Pregabalin within 1 month
Patients who are taking physiotherapy courses will exclude
Life expectancy under 12 month
Patients who are pregnant or during breastfeeding period
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Clinical trial with control groups , parallel group , double-blinded, randomized with placebo(random allocation).In this study we will use Balance Block Randomization.In order to concealment happends , the tables of the groups and the drugs boxes(which includes 2types:the first one is Pregabalin with Placebo and the second one is Pregabalin with Agomelatin)will held by someone except the analyzer or interviewer.Neither the analyzer nor the interviewer do not know about the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to concealment happends , the tables of the groups and the drugs boxes(which includes 2types:the first one is Pregabalin with Placebo and the second one is Pregabalin with Agomelatin)will held by someone except the analyzer or interviewer.Neither the analyzer nor the interviewer do not know about the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
No 24- First west street -24 metres boulvard-saadat abad-tehran - iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۸۶۶۷۱۳۳
Approval date
2020-06-17, 1399/03/28
Ethics committee reference number
IR.IUMS.FMD.REC.1399.200
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Score of pain in brief pain inventory scale (BPI) questionnaire
Timepoint
The beginning of the the study and 1st,4th,8th week
Method of measurement
Brief pain inventory scale (BPI) questionnaire
Secondary outcomes
1
Description
Roland-Morris Disability Questionnaire (RMDQ)
Timepoint
The beginning of the study and 1st,4th,8th week
Method of measurement
Roland-Morris Disability Questionnaire (RMDQ)
2
Description
Score of anxiety and depression by The Hospital Anxiety and Depression Scale (HADS)
Timepoint
The beginning of the study and 1st,4th,8th week
Method of measurement
Roland-Morris Disability Questionnaire (RMDQ)
3
Description
Evaluating the health and function of the patients using SF-36 questionnaire
Timepoint
The beginning of the study and 1st,4th,8th week
Method of measurement
SF-36 questionnaire
4
Description
Evaluating the psychologic status of the patients using GHQ-28 questionnaire
Timepoint
The beginning of the study and 1st,4th,8th week
Method of measurement
GHQ-28 questionnaire
5
Description
Evaluating the demographic variables using the questionnaire designed by the researcher
Timepoint
The beginning of the study and 1st,4th,8th week
Method of measurement
Questionnaire designed by researcher
6
Description
Evaluating the drugs complications by drug checklist designed by researcher
Timepoint
The beginning of the study and 1st,4th,8th week
Method of measurement
drug check list designed by the researcher
Intervention groups
1
Description
Intervention group: we will prescribe Pregabalin 75mg BD + Agomelatin25mg once a day.Before starting Agomelatin and in the 3rd week we will check Liver enzymes. PATIENTS WILL BE EVALUATED IN 0,1,4,8 weeks.in the 1st week the evaluation will be by phone. In the other week the evaluation Will be In clinic.In the 4th week we will Complete the questionnaire and check the Lab data.in the 0,8 week the questionnaire will be completed again too.All the drugs and Laboratory tests and Visit by doktors will be gratitude for the participants.
Category
Treatment - Drugs
2
Description
Control group: we prescribe Pregabalin75mg BD + Placebo once a day. PATIENTS WILL BE EVALUATED IN 0,1,4,8 weeks.in the 1st week the evaluation will be by phone. In the other week the evaluation Will be In clinic.In the 4th week we will Complete the questionnaire and check the Lab data.in the 0,8 week the questionnaire will be completed again too.All the drugs and Laboratory tests and Visit by doktors will be gratitude for the participants.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Shayan Amiri
Street address
Rasoul Akram Hospital-Niayesh street - Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۹۹۸۶۶۴۵۳
Phone
+98 21 6435 2342
Email
amiri.shayan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abas Motevalian
Street address
Iran university of medical science-shahid hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shayan Amiri
Position
Orthopaedic surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No24, First West Street, 24 metres boulvard,saadat abad,tehran , iran
City
Tehran
Province
Tehran
Postal code
1998667133
Phone
+98 21 2236 3375
Fax
Email
Amiri.shayan23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shayan Amiri
Position
Orthopaedic surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No24, First West Street, 24 metres boulvard,saadat abad,tehran , iran
City
Tehran
Province
Tehran
Postal code
1998667133
Phone
+98 21 2236 3375
Fax
Email
Amiri.shayan23@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shayan Amiri
Position
Orthopaedic surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No24, First West Street, 24 metres boulvard,saadat abad,tehran , iran
City
Tehran
Province
Tehran
Postal code
1998667133
Phone
+98 21 2236 3375
Fax
Email
Amiri.shayan23@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
Yes - There is a plan to make this available
Title and more details about the data/document
Participant data
research's protocol
Statistical analysis map
Informed consent form
Clinical research report
Analysis's codes
Data's dictionary
All the datas will be available after making them unknown in order to keep the secrets of the participants.
When the data will become available and for how long
All data will be available after publishing the results
To whom data/document is available
everybody
Under which criteria data/document could be used
it is allowed to do any analysis or researchs with citation.
From where data/document is obtainable
the main researcher - dr shayan amiri by e-mail.
amiri.shayan@gmail.com
What processes are involved for a request to access data/document
After receiving e-mail , i will send all the requested information within 1 week