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*Efficacy of transforaminal hyaluronidase versus transforaminal ozone in herniated lumbar disc pain

Protocol summary

Study aim
Efficacy of transforaminal hyaluronidase versus transforaminal ozone block in disc herniation lumbar pain
Design
This study is a double-blinded clinical trial with parallel control groups.the study is a pilot study and 45 patients in tree groups have involved..
Settings and conduct
45 patients devided to tree groups.group TH received triamcinolone 20 mg,ropivacaine 0.2% 3cc,hyaluronidase 1500 units.group TO received triamcinolone 20 mg,ropivacaine 0.2% and ozone 39 macro 5cc.group TH received triamcinolone 20 mg, ropivacaine 0.2% 3cc, hyaluronidase 1500 units and ozone 39 macro 5cc.After transferring patients to the Rasool Akram hospital interventional pain procedure room,hydration achieved using normal saline 500cc.patient was placed in a prone position.local anesthesia was achieved by subcutaneous administration of 3cc lidocaine 1% injection.Then transforaminal lumbar epidural injection was done.the patients were then transferred to the pre-anesthesia care unit for monitoring vital signs, pain scores, and neurological adverse events.They were discharged home in the care of a responsible adult.Pain score (VAS),Oswestry disability index (ODI) and consumed-drugs measured after 2 weeks, 1 month, 2 months and 3 months.
Participants/Inclusion and exclusion criteria
Inclusions: radicular lumbar pain for more than 6 months,one or two involved levels,no response to conservative therapy for 3 months,pain score more than 3 exclusions: patient discontent,ASA more than 2, pine deformity spine fracture anticoagulation therapy, drug and alcohol abuse,drug allergic reactions, ocal or systemic infection pregnancy,MRI contraindications,severe pulmonary disease,severe psychiatric disease,peripheral neuropathy
Intervention groups
Groups devided to TH(hyaluronidase) ,TO(ozone) and HO(hyaluronidase and ozone).
Main outcome variables
Consumed-drugs,Pain score,Oswestry disability index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181011041308N3
Registration date: 2020-11-27, 1399/09/07
Registration timing: retrospective

Last update: 2020-11-27, 1399/09/07
Update count: 0
Registration date
2020-11-27, 1399/09/07
Registrant information
Name
Mahmoud Reza Alebouyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 6136
Email address
alebuieh.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
*Efficacy of transforaminal hyaluronidase versus transforaminal ozone in herniated lumbar disc pain
Public title
*Efficacy of transforaminal hyaluronidase versus transforaminal ozone in herniated lumbar disc pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Radicular lumbar pain for more than 6 months Disc protrusion One or two levels are involved No response to conservative therapy for 3 months Pain score more than 3
Exclusion criteria:
Patient,s discontent ASA more than 2 Spine deformity Vertebral listhesis ,grade 2 or more Lumbar spine surgery Anti coagulation therapy Drug and alcohol abuse Drug allergic reactions Local or systemic infection Pregnancy MRI contraindications Severe pulmonary disease Severe psychiatric disease Peripheral neuropathy Spine fracture
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly allocated into three groups. This study is a double-blind study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and physicians don't have information about injected drugs.
Placebo
Not used
Assignment
Single
Other design features
45 patients suffering from radicular low back pain, allocated into tree groups.1_group TH received triamcinolone 20 mg,ropivacaine 0/2% 3cc,hyaluronidase 1500 units 2_group TO received triamcinolone 20 mg,ropivacaine 0/2% and ozone 39 macro 5cc3_group HO received triamcinolone 20 mg, ropivacaine 0/2% 3cc ,hyaluronidase 1500 units and ozone 39 macro 5cc. After transferring patients to the interventional pain procedure room, hydration achieved using normal saline 500cc .patient was placed in a prone position and the back was prepped .local anesthesia was achieved by subcutaneous administration of 3cc lidocaine 1% injection. Then transforaminal lumbar epidural injection was done. the patients were then transferred to the pre-anesthesia care unit for monitoring vital signs, pain scores and, neurological adverse events. They were then discharged home in the care of a responsible adult. Pain score (VAS), Oswestry disability index (ODI) and consumed- drugs, measured after 2 weeks, one month, 2months and 3 months.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.IUMS.FMD.REC.1399.424

Health conditions studied

1

Description of health condition studied
lumbar radicular pain
ICD-10 code
G54.1
ICD-10 code description
Lumbosacral plexus disorders

Primary outcomes

1

Description
Visual Analog Scale
Timepoint
2 weeks-1 month- 2 months-3 months
Method of measurement
asking from patient

2

Description
Oswestry Disability Index
Timepoint
2 weeks-1 month-2 months -3 months
Method of measurement
asking from patient

3

Description
consumed- drugs
Timepoint
2 weeks-1 month-2 months -3 months
Method of measurement
asking from patient

Secondary outcomes

empty

Intervention groups

1

Description
Control group: transforaminal hyaluronidase received triamcinolone 20 mg,ropivacaine 0/2% 3cc,hyaluronidase 1500 units
Category
Treatment - Drugs

2

Description
Intervention group: group TO:received triamcinolone 20 mg,ropivacaine 0/2% and ozone 39 macro 5cc3
Category
Treatment - Drugs

3

Description
Intervention group: received triamcinolone 20 mg, ropivacaine 0/2% 3cc ,hyaluronidase 1500 units and ozone 39 macro 5cc
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram hospital pain clinic
Full name of responsible person
Dr Mahmoodreza Alebouyeh
Street address
Interventional operation room,Rasool Akram hospital,Niyayesh street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Email
alebuieh.mr@iums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevallian
Street address
Iran University of Medical Science -Hemmat highway-Tehran
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 8862 2552
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Mahmoodreza Alebouyeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Interventional pain operation room,Rasool Akram hospital,Niyayesh street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Email
alebuieh.mr@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mahmoodreza Alebouyeh
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Interventional pain operation room,Rasool Akram hospital,Niyayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Email
alebuieh.mr@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mahmood Reza Alebouyeh
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Interventional pain operation room,Rasool Akram hospital,Niyayesh street,Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Email
alebuieh.mr@iums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
information about the main and secondary outcomes
When the data will become available and for how long
start the access period immediately after printing the results
To whom data/document is available
only individuals and academic institutions
Under which criteria data/document could be used
The result of any analysis without harmonization and permission is not published
From where data/document is obtainable
alebuieh.mr@iums.ac.ir
What processes are involved for a request to access data/document
The request from the academic university will be answered within ten business days.
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