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Effectiveness of percutaneus epidural neuroplasty(RACZ procidures) with and without epidural OZONE injection in patients with chronic low back pain

Protocol summary

Study aim
Investigating the effect of epidural neuroplasty with and without ozone in chronic low back pain. Determining and comparing the average pain intensity and disability of the patients before the intervention and 24 hours and one and three months after the intervention in two groups.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 38 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Patients with chronic back pain who are candidates for RACZ procedure are assigned to one of two groups A or B based on 1:1 random allocation after obtaining informed consent. The intensity of pain and the degree of disability before the procedure and 24 hours, one month and three months after the procedure are checked and recorded using questionnaires. Patients and those who complete and analyze the questionnaires are not aware of the study groups.
Participants/Inclusion and exclusion criteria
The research population is chronic low back pain patients. Inclusion criteria include age between 25 and 80 years, radicular back pain for at least three months that has not responded to non-invasive treatments including drugs and physical therapy and pain score based on VNS (verbal numerical scale) more than 4. The exclusion criteria include acute trauma patients and spine fractures, malignancies, rheumatic diseases, pregnancy, mental illnesses, peripheral neuropathies, hyperthyroidism and favism, coagulopathy, chronic systemic infection, urinary and fecal incontinence, local infection of the sacrum and The patient's lack of satisfaction at any stage of the research.
Intervention groups
Intervention group or group A (neuroplasty with ozone injection in the epidural space) and control group or group B (neuroplasty without ozone injection in the epidural space).
Main outcome variables
Pain score,, percentage of disability,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150724023315N3
Registration date: 2023-02-24, 1401/12/05
Registration timing: registered_while_recruiting

Last update: 2023-02-24, 1401/12/05
Update count: 0
Registration date
2023-02-24, 1401/12/05
Registrant information
Name
Mahmoud Ganjifard
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1338
Email address
ganjim@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of percutaneus epidural neuroplasty(RACZ procidures) with and without epidural OZONE injection in patients with chronic low back pain
Public title
The effect of ozone on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Radicular back pain for at least three months that has not responded to non-invasive treatments including medicine and physical therapy. 2- The pain score based on VNS (verbal numerical scale) should be more than 4
Exclusion criteria:
Patients with acute trauma and spinal fractures, malignancies rheumatic diseases pregnancy mental illnesses peripheral neuropathies hyperthyroidism coagulopathy chronic systemic infection urinary and fecal incontinence local infection of the sacrum area patient dissatisfaction favism
Age
From 25 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the randomized permutation block with Excel software. The blocks are provided to the attending physician and when each patient enters, a block envelope is randomly selected and based on the sticker removed, the patient will be assigned to the relevant treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, those who register the results of the intervention and statistical analysis are not aware of what intervention was done for each patient and each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Neuroscience Research Institute, Tehran University of Medical Sciences
Street address
Keshavarz Boulevard
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.TUMS.NI.REC.1401.085

Health conditions studied

1

Description of health condition studied
chronic low back pain
ICD-10 code
g55.1
ICD-10 code description
Nerve root and plexus compressions in intervertebral disc disorders

Primary outcomes

1

Description
Pain intensity of patients based on verbal numeric scale (VNS)
Timepoint
before the intervention, twenty-four hours, one month and three months after the intervention
Method of measurement
Pain intensity assessment questionnaire

2

Description
The percentage of disability due to back pain based on the OSWESTRY disability index questionnaire
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
OSWESTRY disability index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group(neuroplasty using the RACZ method plus ozone): The neuroplasty procedure of patients is performed in the operating room under aseptic conditions. The patient is placed in the prone position and standard monitoring (including blood pressure, ECG and pulse oximetry) and venous access are established and intravenous sedation with midazolam and fentanyl is prescribed. After the scraping, the doctor disinfects the area (waist, sacrum, and buttocks) with betadine, wearing a sterile gown, gloves, hat, and mask, and covers the patient's body with a sterile gown from the upper thoracic region to the knees. After the administration of prophylactic antibiotic (one gram of intravenous cefazolin), a 15G or 16G size epidural needle is inserted through the sacral hiatus under fluoroscopy guidance and 10 cc of contrast is injected to determine the location of the adhesion and defect. The RACZ catheter is inserted through the epidural needle and guided to the adhesion site or the area determined according to the patient's symptoms or MRI, and removal of the adhesion is done with mechanical maneuvers. In the next step, 1500 units of hyaluronidase dissolved in 10 cc of normal saline are injected, followed by 10 cc of 0.25% ropivacaine solution and 40 mg of methylprednisolone. in this group, 10 cc of ozone 25 micrograms per cc are injected. Finally, after 15 to 20 minutes, 5% hypertonic saline solution is injected in both groups for 15 minutes. At the end, the catheter is removed and the health of the catheter is checked. The patient is checked for sensory and motor deficits and is discharged home with education.
Category
Treatment - Drugs

2

Description
Control group(neuroplasty using the RACZ method): The neuroplasty procedure of patients is performed in the operating room under aseptic conditions. The patient is placed in the prone position and standard monitoring (including blood pressure, ECG and pulse oximetry) and venous access are established and intravenous sedation with midazolam and fentanyl is prescribed. After the scraping, the doctor disinfects the area (waist, sacrum, and buttocks) with betadine, wearing a sterile gown, gloves, hat, and mask, and covers the patient's body with a sterile gown from the upper thoracic region to the knees. After the administration of prophylactic antibiotic (one gram of intravenous cefazolin), a 15G or 16G size epidural needle is inserted through the sacral hiatus under fluoroscopy guidance and 10 cc of contrast is injected to determine the location of the adhesion and defect. The RACZ catheter is inserted through the epidural needle and guided to the adhesion site or the area determined according to the patient's symptoms or MRI, and removal of the adhesion is done with mechanical maneuvers. In the next step, 1500 units of hyaluronidase dissolved in 10 cc of normal saline are injected, followed by 10 cc of 0.25% ropivacaine solution and 40 mg of methylprednisolone.Finally, after 15 to 20 minutes, 5% hypertonic saline solution is injected in both groups for 15 minutes. At the end, the catheter is removed and the health of the catheter is checked. The patient is checked for sensory and motor deficits and is discharged home with education.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Street address
Keshavarz Blvd., corner of Qods, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8163 3141
Email
TUMSPR@TUMS.AC.IR
Web page address
http://tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghenaatie dr.
Street address
Keshavarz Blvd., corner of Qods, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Web page address
http://tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Position
assistant of fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 138, Nusrat St., Jamalzadeh St
City
tehran
Province
Tehran
Postal code
1419853851
Phone
+98 21 6119 2210
Email
fardganj@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Position
assistant of fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 138, Nusrat St., Jamalzadeh St
City
tehran
Province
Tehran
Postal code
1419853851
Phone
+98 21 6119 2210
Email
fardganj@gmail.com
Web page address
http://tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Position
Assistant of Fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 138, Nusrat St., Jamalzadeh St
City
Tehran
Province
Tehran
Postal code
1419853851
Phone
+98 21 6119 2210
Email
fardganj@gmail.com
Web page address
http://tums.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
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