Determining the effectiveness of epidural injection of two different doses of hyaluronidase in the outcome of patients with back surgery failure syndrome
Design
A clinical trial with a control group, with parallel groups. Two blind strains. Phase 3 was randomized on 40 patients and balanced block was used for randomization.
Settings and conduct
It is an intervention study and a clinical trial type. The sample size is 40 people. Patients with low back pain syndrome in the operating room of Shahid Beheshti Hospital, Qom and after obtaining written consent, are divided into two groups by randomization using block randomization method: The first group includes 20 patients who received caudal and transforaminal epidural injections. hyaluronidase are placed. The second group of 20 patients will undergo caudal epidural and transforaminal hyaluronidase injection.
Participants/Inclusion and exclusion criteria
Entry requirements: age older than18 years old; patients who have not responded satisfactorily to 6 weeks of medical treatment despite the annoying pain NRS>=5. Non-entry conditions: prohibition of withdrawal of hyaluronidase due to allergy; nerve damage and vascular collagen diseases; bleeding disorders and anticoagulant use.
Intervention groups
The control group, after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal hyaluronidase 1500 IU (HYL) and triamcinolone 80 mg.
The intervention group, after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal injection of hyaluronidase 3000 IU (HYL) and triamcinolone 80 mg.
Main outcome variables
Pain level; disability level
General information
Reason for update
Acronym
FBSS
IRCT registration information
IRCT registration number:IRCT20240827062876N1
Registration date:2024-09-05, 1403/06/15
Registration timing:prospective
Last update:2024-09-05, 1403/06/15
Update count:0
Registration date
2024-09-05, 1403/06/15
Registrant information
Name
mahsa mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
bem_beg88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-20, 1403/08/30
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two doses of hyaluronidase in the outcome of epidural steroid injection in patients with failed back surgery syndrome
Public title
Epidural injection of hyaluronidase in failed back surgery syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients to remove adhesions with medication
Age older than 18 years
History of epidural steroid injection in the last six months
Patients who have not responded satisfactorily to 6 weeks of medical treatment despite the annoying pain NRS>=5
The presence of evidence of pressure on the lumbar spinal cord in MRI
Exclusion criteria:
Hyaluronidase contraindications
Symptoms of cauda equina, spinal canal stenosis requiring surgery, psychosomatic disease
suffering from diabetes; Suffering from rheumatic diseases and vascular collagen and gout and lupus
Having nerve damage and neuropathies
Suffering from bleeding diseases
Inability to communicate
History of allergies and allergic reactions to the drugs used
History of significant liver, kidney and cardio-pulmonary disorders
Pregnancy
Suffering from cancers
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (40 samples), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Based on the block randomization method, patients will be divided into two control and intervention groups of 20 people. In a group of anesthesiologists who will not know the type of research, patients will be given epidural injections under one of two doses of the drug based on the sealed envelope in which the drug dose is specified. The principal investigator will not know which patient is receiving which block. The patient and the person filling the questionnaire do not know the type of block.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
IR.MUQ.REC.1402.223
Health conditions studied
1
Description of health condition studied
Failed back surgery syndrome
ICD-10 code
M96.1
ICD-10 code description
Postlaminectomy syndrome, not elsewhere classified
Primary outcomes
1
Description
Pain Level
Timepoint
Two weeks, one month, three months and six months after treatment
Two weeks, one month, three months and six months after treatment
Method of measurement
Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal injection of hyaluronidase 3000 IU (HYL) and triamcinolone 80 mg.
Category
Treatment - Drugs
2
Description
Control group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal hyaluronidase 1500 IU (HYL) and triamcinolone 80 mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
mahsa mehrabi
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
37719964797
Phone
+98 25 3612 2000
Email
bem_beg88@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 4011
Email
rahimalii@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Reza Aminnejad
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti hospital; Shahid Beheshti Ave.
City
Ghoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
r.aminnejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
reza aminnejad
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti hospital; Shahid Beheshti Ave.
City
Ghoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
r.aminnejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mahsa Mehrabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Beheshti hospital; Shahid Beheshti Ave.
City
GHoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
bem_beg88@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available