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evaluation of the efficacy of hyaluronidase and steroid epidural injection compared with hypertonic saline and steroid epidural injection in the treatment of lumbosacral spinal stenosis

Protocol summary

Study aim
ِDetermination of the efficacy of hyaluronidase and steroid epidural injection compared with hypertonic saline and steroid epidural injection
Design
In this research , 30 eligible patients will be divided randomly into two groups. First group will receive saline 5% 15cc, methylprednisolone 80 mg, and marcaine 4cc while the second group will receive hyalorunidase 1500 IU , methylprednisolone 80 mg, and marcaine 4cc.the injection will be done under fluoroscopic guide and after contrast media injection to confirm the best site for injection . appropriate life style and low back exercise will be educated to both groups. Both groups will complete VAS , oswestry disability index and quebec back pain disability scale questionnaires before the procedure and 2, 4 and 8 weeks after procedure. The data will be statistically analyzed by a person who will be blinded to the treatment to compare these 2 methods in pain reduction and improving patient’s function.
Settings and conduct
Chamran hospital, Shiraz, Fars , Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Patients with lumbosacral spinal stenosis who have pain and other clinical symptoms didn’t respond to conservative management ; Age between 45 – 75 years old ; Complete and sign constent form Exclusion criteria: Simultaneous radiculopathy ; Diabetes mellitus ; Rheumatologic disease such as collagen vascular disease , SLE , gout ; Simultaneous neuropathy ; Brucella infection ; BMI> 42 ; Knee arthroplasty in affected side ; Coaglopathy ; Allergy to medication ; Hepatic , renal or cardiac failure ; Cancer ; Pregnancy ; Inability to complete questionnaire and poor cooperation ; patients who are under anticoagulant therapy
Intervention groups
Epidural injection under fluoroscopic guide , First intervention group will receive saline 5% 15cc, methylprednisolone 80 mg, and marcaine 4cc while the second group will receive hyalorunidase 1500 IU , methylprednisolone 80 mg, and marcaine 4cc.the injection will be done under fluoroscopic guide and after contrast media injection to confirm the best site for injection . appropriate life style and low back exercise will be educated to both groups.
Main outcome variables
Pain reduction ; Functional improvement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171106037267N2
Registration date: 2018-02-10, 1396/11/21
Registration timing: registered_while_recruiting

Last update: 2018-02-10, 1396/11/21
Update count: 0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
anis ghorbani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 6034
Email address
an_ghorbani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
research deputy of shiraz university of medical sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the efficacy of hyaluronidase and steroid epidural injection compared with hypertonic saline and steroid epidural injection in the treatment of lumbosacral spinal stenosis
Public title
effect of hyalorunidase and steroid epidural injection in lumbar spinal stenosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lumbosacral spinal stenosis who have pain and other clinical symptoms didn’t respond to conservative management Age between 45 to 75 y/o Complete and sign constent form Exclusion
Exclusion criteria:
Diabetes mellitus Rheumatologic disease such as collagen vascular disease , SLE , gout Simultaneous radiculopathy Simultaneous neuropathy Brucella infection BMI> 42 Knee arthroplasty in affected side Coaglopathy Inability to complete questionnaire and poor cooperation Allergy to medication Hepatic , renal or cardiac failure Pregnancy Cancer Patients who are receiving Anticoagulant
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized Block Design with statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and researcher( who complete the questionnaire) don't know type of injection drug
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 SciencesShiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.SUMS.MED.REC.1396.102

Health conditions studied

1

Description of health condition studied
Lumbosacral spinal stenosis
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region

Primary outcomes

1

Description
Patient's pain
Timepoint
Before injection , 2, 4 and 8 weeks after injection
Method of measurement
Visual Analogue Scale , Quebec back pain disability scale and Oswestry disability index questionnaire

2

Description
Functional improvement
Timepoint
Before injection , 2, 4 and 8 weeks after injection
Method of measurement
Quebec back pain disability scale and Oswestry disability index questionnaire

Secondary outcomes

1

Description
ًQuality of life improvement
Timepoint
Befor injection , 2, 4 and 8 weeks after injection
Method of measurement
Quebec back pain disability scale and Oswestry disability index questionnaire

2

Description
Decrease analgesic usage
Timepoint
Before injection , 2, 4 and 8 weeks after injection
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention group: will receive hyalorunidase 1500 IU , methylprednisolone 80 mg, and marcaine 4cc.the injection will be done under fluoroscopic guide and after contrast media injection to confirm the best site for injection . appropriate life style and low back exercise will be educated to both groups
Category
Treatment - Drugs

2

Description
Control group: Control group will receive saline 5% 15cc, methylprednisolone 80 mg, and marcaine 4cc .The injection will be done under fluoroscopic guide and after contrast media injection to confirm the best site for injection . appropriate life style and low back exercise will be educated to both groups
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Dr Alireza Ashraf
Street address
next to Nyayesh Blvd.Chamran highway
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3231 9040
Email
An_ghorbani@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Alireza Ashraf
Street address
Central building of Shiraz University of Medical Sciences , Imam Hossein Square , Zand Blvd.,
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3232 9040
Email
an_ghorbani@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
Dr Alireza Ashraf
Position
Professor of Shiraz University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Central building of Shiraz University of Medical Sciences , Imam Hossein Square , Zand Blvd.,
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Fax
Email
an_ghorbani@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Alireza Ashraf
Position
Professor of Shiraz University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Central building of Shiraz University of Medical Sciences., Imam Hossein Square , Zand Blvd.,
City
ُُShiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3231 9040
Fax
Email
an_ghorbani@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Alireza Ashraf
Position
Profesor of Shiraz University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Central building of Shiraz University of Medical Sciences., Imam Hossein Square , Zand Blvd.,
City
Shiraz
Province
Fars
Postal code
14336 71348
Phone
+98 71 3231 9040
Fax
Email
an_ghorbani@sums.ac.ir
Web page address

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
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