Comparison of the effect of calcitonin injection in the form of mesotherapy with epidural steroid injection in patients with spinal cord stenosis
Design
In this study, 20 patients with lumbar spinal stenosis who had the conditions for entering the study were randomly divided into two groups of 10, the first group was calcitonin by mesotherapy and the second group was epidural steroid injection.
Settings and conduct
This is a double-blind, randomized clinical trial that will be conducted on referrals to physical medicine and rehabilitation clinics of Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Persons aged 40 to 75 who are able to complete questionnaires
Diabetes mellitus, rheumatic diseases, collagen and vascular disease, gout. Lupus, nerve damage, neuropathies and brucella BMI >42 History of trauma and spinal fractures and spondylolisthesis, History of injections inside or around a joint bleeding disorders History of allergy and allergic reaction to used drugs History of significant liver, kidney and cardiac disorders Use of anticoagulants
Intervention groups
The first group of calcitonin was injected with mesotherapy. The second group of steroids was injected epidural.
Main outcome variables
Reduce the need for epidural injections and reduce the side effects of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171201037696N1
Registration date:2018-01-14, 1396/10/24
Registration timing:registered_while_recruiting
Last update:2018-01-14, 1396/10/24
Update count:0
Registration date
2018-01-14, 1396/10/24
Registrant information
Name
Elham Sheibani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3824 5055
Email address
a_sheibani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of calcitonin by mesotherapy versus esteroid epidural injection in spinal canal stenosis
Public title
calcitonin mesotherapy in spinal canal stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain and other clinical symptoms of lumbar canal stenosis
Complete and sign the consent form
Age between 40 and 75 years
Exclusion criteria:
Diabetes mellitus, rheumatic diseases, collagen and vascular disease, gout. Lupus, nerve damage, neuropathies and brucella
BMI >42
History of trauma and spinal fractures and spondylolisthesis,
History of injections inside or around a joint
bleeding disorders
History of allergy and allergic reaction to used drugs
History of significant liver, kidney and cardiac disorders
Use of anticoagulants
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized blocked method
Blinding (investigator's opinion)
Single blinded
Blinding description
A single blind trials that the patient and the investigator are aware of how the study is conducted, but the statistical analyzer is kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fars Province, Shiraz, Zand
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.70
Health conditions studied
1
Description of health condition studied
spinal canal stenosis
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region
Primary outcomes
1
Description
Reducing pain after undergoing mesotherapy
Timepoint
Before starting treatment and 4 and 8 weeks after injection
Method of measurement
Visual Analogue Scale Questionnaire
Secondary outcomes
1
Description
Evaluation the effect of calcitonin mesotherapy and epidural steroid on functional improvement
Timepoint
Before starting treatment and 4 and 8 weeks after injection
Method of measurement
Oswestry Disability Index Questionnaire. Quebec Back pain Disability index
Intervention groups
1
Description
Intervention group: Injection of calcitonin by mesotherapy
Category
Treatment - Drugs
2
Description
Intervention group: epidural steroid injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Physical Medicine and Rehabilitation of Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Farpoor
Street address
Fars Province, Shiraz, Zand, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
a_sheibani@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seied Basir Hashemi
Street address
Fars Province, Shiraz, Zand, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Reza Farpoor
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Fars Province, Shiraz, Zand, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
a_sheibani@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Farpoor
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Fars Province, Shiraz, Zand
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
farporh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham sheibani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.367,Adl Ave.,Edalat Blvd.,Shiraz Town
City
Shiraz
Province
Fars
Postal code
7167673878
Phone
+98 71 3824 5055
Email
a_sheibani@sums.ac.ir
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