The effectiveness of duloxetine on quality of life and severity of pain is assessed in patients with chronic low back pain who have undergone posterior spinal fixation surgery.
Design
Randomized, double blind , placebo-controlled
Simple or unlimited randomization with coin throwing in such a way that coins are thrown according to the number of members and individuals are randomly assigned.
Settings and conduct
This trial will be conducted in neurosurgery department of Rasoul-e Akram hospital in Tehran . 50 patients with chronic low back pain who are candidates for posterior spinal fixation surgery are divided into two groups (drugs and placebo). They fill out VAS and SF-36 questionnaires before surgery and after 6 weeks of taking 30 mg of doloxacin or placebo.
Participants/Inclusion and exclusion criteria
Patients older than 18 years old and younger than 80 , must discontinue any medication that could interfere with their pain such as nonopioid or opioid drugs , antidepressants and anticonvulsants at least for 6 months before surgery , non pharmacological pain-relieving procedures such as acupuncture or physical therapies
Exclusion criterias are : prior use of opioids , depression , use of antidepressants , drug abuse , pregnancy and breast feeding , severe coexisting diseases such as heart failure , severe hypertension , convulsion and kidney dysfunction.
Intervention groups
The patients with chronic low back pain (more than 3 months ) and candidate for posterior spinal fixation are randomised divide in two groups ( duloxetine or placebo ).
In first step all patients will fill the VAS and SF-36 and questionnaires and after the surgery the drug group will receive 30 mg of duloxetine and placebo group will receive placebo for 6 weeks. After this time all the patients again will fill the questionnaires.
Main outcome variables
Changes in quality of life standards
Changes in pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191210045685N1
Registration date:2020-07-04, 1399/04/14
Registration timing:retrospective
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Arezoo Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 6936
Email address
arezoosamadi1980@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effetiveness of Duloxetine on severity of pain and quality of life in chronic low back pain in patients who had posterior spinal fixation (PSF)
Public title
Effectiveness of duloxetine in chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years old and younger than 80 with chronic low back pain (more than 3 months duration) who are candidate for posterior spinal fixation surgery.
All patients have to discontinue any medication that could interfere with their pain such as nonopioid or opioid drugs , antidepressants and anticonvulsants at least for 6 months before surgery.
Non pharmacological pain-relieving procedures such as acupuncture or physical therapies are not allowed during the study.
Exclusion criteria:
prior use of opioids , antidepressants , drug abuse
depression
pregnancy and breast feeding
severe coexisting diseases such as heart failure , severe hypertension , convulsion and kidney dysfunction
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple or unlimited randomization with coin throwing in such a way that coins are thrown according to the number of the members and individuals are randomly assigned to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are explained that they will be randomly assigned to one of the two groups of drugs or placebo, but they do not know which group they are in.
The resident in charge of filling out the questionnaires and distributing the medicine or placebo is also not aware of them and distributes the medicine and placebo in the same containers among the patients.
The same is true of the analyzer.
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. 3/5/1, 16th velenjak St., Tehran , Iran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۳۸۶۵۱
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR. IUMS.FMD.REC.1398.016
Health conditions studied
1
Description of health condition studied
Effectiveness of duloxetine in posterior spinal fixation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effectiveness of duloxetine on quality of life in chronic low back pain in patients who had posterior spinal fixation measured with SF36 questionnaire / Effectiveness of duloxetine on severity of pain in chronic low back pain in patients who had posterior spinal fixation measured with VAS questionnaire.
Timepoint
all patients will fill the questionnaires at first step of study and one more 6 weeks later
Method of measurement
SF36 questionnaire / VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After posterior spinal fixation surgery case group receive 30 mg of duloxetine for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: : After posterior spinal fixation surgery control group receive placebo for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul -e Akram Hospital Iran University of Medical Sciences
Full name of responsible person
Arezoo Samadi
Street address
No. 3/5/1/2 ,16th Ave. Velenjak St. Tehran
City
Tehran
Province
Tehran
Postal code
1985738651
Phone
+98 21 2227 6936
Email
arezoosamadi1980@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari Jolfaie
Street address
No.3/5/1/2 ,16th Ave. Velenjak St. Tehran
City
Tehran
Province
Tehran
Postal code
1985738651
Phone
+98 21 2227 6936
Email
draghj@yahoo.com
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
Arezoo Samadi
Position
Psychiatrist , Fellowship of Psychosomatic Medicine
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 3/5/1/2 ,16th Ave. Velenjak St. Tehran
City
Tehran
Province
Tehran
Postal code
1985738651
Phone
+98 21 2227 6936
Email
arezoosamadi1980@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arezoo Samadi
Position
Psychiatrist / Fellowship of Psychosomatic
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 3/5/1/2 , 16th Ave. Velenjak St. Tehran
City
Tehran
Province
Tehran
Postal code
1985738651
Phone
+98 21 2227 6936
Email
arezoosamadi1980@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Arezoo Samadi
Position
Psychiatrist / Fellowship of Psychosomatic Medicine
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 3/5/1/2 , 16th Ave. Velenjak St. Tehran
City
Tehran
Province
Tehran
Postal code
1985738651
Phone
+98 912 322 6849
Email
arezoosamadi1980@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