Evaluation of effect of 5% dextrose epidural injections in reducing chronic low back pain
Design
Clinical trial with 3 parallel groups, triple blind, randomized, phase 2 on 150 patients, in block randomization method with the size of 4 and 6, Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/).
Settings and conduct
The aim of the study is evaluation of effect of 5% dextrose epidural injections in reducing chronic low back pain in 150 patients of Valiasr hospital in Arak city.In first group (Dextrose) 10 cc of Dextrose 5%, in second group (local anesthesia) 15 cc of Marcaine 0.5% and in third group (compound) 10 cc of Dextrose 5% and 10 cc of Marcaine 0.5% will be injected to epidural space in the patients in 0,7,15,30 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Moderate to severe low back pain (5 or more score in VAS) for at least 6 months
Do not response to common treatment
Able to seating position
Non-inclusion criteria:
Progressive weakness
Recent bladder or intestinal dysfunction
Local infection
Unstable psychological disorders
Other chronic pains such as pain of upper extremities
Anticoagulation state
Pregnancy
Indication of surgery
Underlying disease such as cardiovascular, renal or severe pulmonary disorders
Intervention groups
In first group (Dextrose) 10 cc of Dextrose 5%, in second group (local anesthesia) 15 cc of Marcaine 0.5% and in third group (compound) 10 cc of Dextrose 5% and 10 cc of Marcaine 0.5% will be injected to epidural space in the patients in 0,7,15,30 days.
Main outcome variables
Patients pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049175N5
Registration date:2021-03-01, 1399/12/11
Registration timing:prospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Shamim Valibak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
sh.valibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 5% dextrose epidural injections in reducing chronic low back pain
Public title
Effect of 5% dextrose epidural injections in reducing chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe low back pain (5 or more in VAS(Visual Analogue Scale)) for at least 6 months.
Able to seating position
Do not response to common treatment
Patients with 20-75 years old
Exclusion criteria:
Progressive weakness
Recent bladder or intestinal dysfunction
Local infection
Unstable psychological disorders
Other chronic pains such as pain of upper extremities
Anticoagulation state
Pregnancy
Indication of surgery
Underlying disease such as cardiovascular, renal or severe pulmonary disorders
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into three groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient blindness:
Drugs in 3 groups are similar in shape and feature.
Blindness of person who fill the check lists:
Drugs will be ordered and injected by anesthesiologists so the person who fill the check lists will unaware about kind of drug inject to each patient.
Analyzer blindness:
Data of the patients except kind of drug received will be delivered to analyzer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.ARAKMU.REC.1399.316
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Patients pain score
Timepoint
In recovery (15 minutes after injection), 2,4,12,24 and 48 hours after injections and after last injection every week till one month and then every month for three months.
Method of measurement
VAS (Visual Analogue Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In first group (Dextrose) 10 cc of 5% Dextrose will be injected to epidural space in 0,7,15,30 days.
Category
Treatment - Other
2
Description
Intervention group:In second group (local anesthesia) 15cc of Marcain 0.5% will be injected to epidural space in 0,7,15,30 days.
Category
Treatment - Drugs
3
Description
Intervention group:In third group (combined) 10 cc of Marcain 0.5% and 10 cc of 5% Dextrose will be injected to epidural space in 0,7,15,30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Alireza Kamali
Street address
Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Assistance of research and technology of Arak university of medical science-Dr Alireza Kamali
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Nazemi Rafi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
nazemirafie.ali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shamim Valibak
Position
General physician non-faculty
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
086-32222003-8
Email
sh.valibak@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