A comparison between effectiveness of gluteal trigger points injection with epidural steroid injection in lumbosacral canal stenosis patients
Design
the research is a randomize double blind clinical trial
Settings and conduct
the patient selected from emamreza clinic and rajaee hospital who has lumbosacral canal stenosis. then patients divided into two groups and after obtaining written consent the study begins. in control group steroid epidural injection is done and in intervention group steroid is gluteal trigger point injection then we measure its effect on reducing pain and improving patients function
Participants/Inclusion and exclusion criteria
exclusion criterria:
Infection involving lumbar spinal (brucella)
Diabetes mellitus
Rhumatological disorder(lupuse, gout)
BMI more than 42
Pregnancy
Malignancy
Liver disease
History of allergies
Malnutrition
Peripheral neuropathy
Bleeding disorder
Galactosemia
Radiculopathy
inclusion criteria:
age: 40-75 years old
being diagnosis with lumbar canal stenosis accordining to MRI or EDX
Complaining low back pain , psudoclaudication ,parestesia that no responsed to conservative treatment
sex:male or female
Intervention groups
group that receive gluteal trigger point injection of steroid
Main outcome variables
pain, activity of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190802044411N1
Registration date:2020-11-26, 1399/09/06
Registration timing:registered_while_recruiting
Last update:2020-11-26, 1399/09/06
Update count:1
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
Sana Khoshnazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3875 2488
Email address
khoshnazar31@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between effectiveness of gluteal trigger injection with epidural steroid injection in lumbosacral canal stenosis patients
Public title
Gluteal trigger point injection in lumbosacral canal stenosis pateints
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age : 40 to75 years old
Being diagnosis with lumbar canal stenosis according to mri or edx
Complaining low back pain , psudoclaudication , parestesia that no responsed to conservative treatment
Gender: male or female
Exclusion criteria:
Infection involving lumbar spinal (brucella)
Diabetes mellitus
Rhumatological disorder(lupuse, gout)
BMI more than 42
Pregnancy
Malignancy
Liver disease
sensitivity reaction to test drug
Malnutrition
Peripheral neuropathy
Bleeding disorder
Galactosemia
Radiculopathy
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Complete randomize block design with random allocation software is used for randomization and the list of patient is prepared by a computer with the same blocklength and the secretary divides the patients based on the list of patients and the statistical consultant on how to group are unaware.
Blinding (investigator's opinion)
Triple blinded
Blinding description
participanr: in. this study does not have the ability to blind the participant because the participant is aware of receiving each intervention
clinical car giver : we teach the caregiver how to complete the questionnaire. this person is not aware of receiving patient intervention .
researcher: this study does not have the ability to blind the researcher because performs both intervention himself and is aware of receiving each intervention in the group.
The outcome assessor of the complete questionnaires is given to person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires.
Data analyzer: questionnaire are finally given to a person to review the information . this person dosenot know any of the eteps of the work , how to classify and the intervention performed.
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
No.6, Baharan Ave , Maali abad Blvd
City
shiraz
Province
Fars
Postal code
7184747811
Approval date
2019-06-22, 1398/04/01
Ethics committee reference number
IR.SUMS.MED.REC.1398.221
Health conditions studied
1
Description of health condition studied
lumbosacral canal stenosis
ICD-10 code
M99.53
ICD-10 code description
Intervertebral disc stenosis of neural canal of lumbar region
Primary outcomes
1
Description
radicular low back pain
Timepoint
two weeks, foure weeks , eight weeks
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
function of patient
Timepoint
two weeks, four weeks , eight weeks
Method of measurement
The Quebec Back Pain Disability Scale
2
Description
function of patient
Timepoint
two weeks, four weeks , eight weeks
Method of measurement
Ronald-Morris Disability questionnaire
3
Description
function of patient
Timepoint
two weeks, four weeks , eight weeks
Method of measurement
Oswestry Disability index
Intervention groups
1
Description
Intervention group: the group that receive 80 mg methylprednisolon and 4 cc marcaine epidural injection with fluoroscopic guidance and two weeks , four weeks, eight weeks after first dose VAS, Oswestry, Quebec , RMQ was full
Category
Rehabilitation
2
Description
Control group: the group that receive 80 mg methylprednisolon and 5 cc lidocaine gluteal trigger point injectionand two weeks , four weeks, eight weeks after first dose VAS, Oswestry, Quebec , RMQ was full
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza rehabilitation clinic
Full name of responsible person
Mani Ramzi
Street address
Namazi square
City
shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7700
Email
motahari@sums.ac.ir
2
Recruitment center
Name of recruitment center
Rajaee hospital
Full name of responsible person
Amirreza mesbahi
Street address
chamran Blvd
City
shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
Rajaeehospital@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
دکتر قاسمی
Street address
Khalili Aveno, front of maaref school
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
Info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Sana sadat Khoshnazar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
NO 6,Baharan Aveno , Maaliabad Blvd
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
Khoshnazar31@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sana sadat Khoshnazar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
NO 6, Baharan Ave , Maaliabad Blvd
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
khoshnazar31@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sana sadat Khoshnazar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
NO 6 , Baharan Ave, Maaliabad Blvd
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
Khoshnazar31@yahoo.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
All available data can be shared after making people unidentifiable
When the data will become available and for how long
start access period one year after publishing the results
To whom data/document is available
everyone can access to this information
Under which criteria data/document could be used
if the information in this study helps to improve the science process
From where data/document is obtainable
khoshnazar31@yahoo.com
00989131434549
What processes are involved for a request to access data/document
after sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.