the Long Term Therapeutic Effect of Short Term Oral Corticosteroid Treatment in Patients with Acquired Lumbar Canal Stenosis.
Design
A Clinical Trial Study with Control Group with Parallel, One blind and Randomized Groups with 100 Patients.
Settings and conduct
Patients with clinical sign and symptoms of lumbar spinal stenosis Referred to the Orthopedic Clinic of Isfahan University of Medical Sciences are Divided into Two Groups. Group 1 Received Prednisolone Tablets (70 mg) for One Week and treated with Pills of Meloxicam and Pantoprazole and Vitamin E for 20 Days. The Group 2 was Treated with Meloxicam Tablets and Pantoprazole and Vitamin E for 20 days, and the Clinical Symptoms of the Patient were Compared Before intervention and 2 Months Later.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Acquired Lumbar Spinal Canal Stenosis,
Age Over 18 Years
Exclusion Criteria:History of Corticosteroid Use in The Last Three Months,
Concomitant with Other Systemic Diseases, Such as high Blood Pressure, Diabetes , history of previous surgery on the spine
Intervention groups
A Total of 100 Patients with Spinal Stenosis Were Selected Randomly According to Clinical Manifestations and MRI Findings. Group 1 was Treated With Prednisolone Tablets, Meloxicam and Pantoprazole and Vitamin E, While Group 2 was Treated with Meloxicam and Pantoprazole and vitamin E.
Main outcome variables
Patient Distance
Quality of Life
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180729040636N1
Registration date:2019-01-14, 1397/10/24
Registration timing:prospective
Last update:2019-01-14, 1397/10/24
Update count:1
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Hossein Akbari aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
akbariaghdam@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-18, 1397/10/28
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Long Term Therapeutic Effect of Short Term Oral Corticosteroid Treatment in Patients with Acquired Lumbar Canal Stenosis.
Public title
Effect of Corticosteroid in Lumbar Spinal Canal Stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written Consent to Enter Study
Age Over 18 Years
Acquired Spinal Canal Stenosis
No History of Corticosteroid Susceptibility
Exclusion criteria:
Concomitant With Other Systemic Diseases, Such as Blood pressure, Diabetes.
History of Corticosteroid Use in The Last Three Months.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The Data Analyzer Has been Blinded to Control and Intervention Groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences & Health Services, Building No. 4, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.149
Health conditions studied
1
Description of health condition studied
Acquired Lumbar Spinal Canal stenosis
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region
Primary outcomes
1
Description
Distance
Timepoint
Before the Intervention and 2 Months Later.
Method of measurement
Metre
2
Description
Quality of Life
Timepoint
Before the Intervention and 2 Months Later.
Method of measurement
OSWESTRY LOW BACK PAIN SCORE QUESTIONNAIRE
Secondary outcomes
1
Description
The Amount of Pain
Timepoint
Before the Intervention and 2 Months Later
Method of measurement
PAIN Numerical Rating Scale
2
Description
Low Back Pain
Timepoint
Before the Intervention and 2 Months Later
Method of measurement
Check List
Intervention groups
1
Description
Intervention Group: Taking 10 mg of Prednisolone Daily for One Week, Meloxicam tablets 7.5 Mg and Vitamin E and Pantoprazole 20 Mg for 20 days and Recording the Clinical Symptoms and Quality of Life Before the Intervention and 2 Months Later.
Category
Treatment - Drugs
2
Description
Control Group:Taking Meloxicam 7.5 Mg and vitamin E and Pantoprazole 20 Mg for 20 days and Recording Clinical Symptoms and Quality of Life Before the Intervention and 2 Months Later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic Clinic of Alzahra Hospital
Full name of responsible person
Hossein Akbariaghdam
Street address
Sofah Boulevard., Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5149
Email
Akbariaghdam@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Orthopedic Clinic of Kashani Hospital
Full name of responsible person
Hossein Akbariaghdam
Street address
Kashani Street., Kashani Hospital
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
Akbariaghdam@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbariaghdam
Street address
Hezar Jereb Street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Akbariaghdam@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbariaghdam
Position
Assistant Professor of Orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3620 2085
Email
Akbariaghdam@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbariaghdam
Position
Assistant Professor of Orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital, Kashani Street, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3620 2085
Email
Akbariaghdam@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbariaghdam
Position
Assistant Professor of Orthopedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital, Kashani Street
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3620 2085
Email
Akbariaghdam@med.mui.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