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Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone in patients with lumbar discopathy in terms of quality of life

Protocol summary

Study aim
Objective: to determine the superiority of laser assisted intradiscal nucleoplasty with or without Ozone in controlling pain and disability in patients with lumbar discopathy
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
Settings and conduct
The study will be done in Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Tehran University of Medical Science. After informed consent, the patients will be included in the study. The responsible doctor, operation theater staff (other than the surgeon who performs the procedure) and statistical consultant will be blind to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: radicular low back pain with evidence of discopathy/discopathies of L3-L4, L4-L5 or L5-S1 in MRI in patients who fail to respond to conservative therapy and peri-root therapy. Exclusion criteria: Previous back surgery, bleeding tendency, drug abuse, non-controlled psychiatric disorders, lower extremity weakness, sphincter disorder, disc protrusion more than one third of anterior-posterior spinal column diameter in MRI, disc extrusion or sequestration in MRI
Intervention groups
In both groups A and B, intradiscal nucleoplasty will be done using Diode laser PW 3.5-5 W 1200-1500 J. In group B, after completion of nucleoplasty, 2 ml of Ozone 45 mcg/ml will be injected into the disc(s).
Main outcome variables
NRS (Numerical rating scale): Simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain). Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

General information

Reason for update
Acronym
OLINT (Ozone Laser Intradiscal Nucleoplasty Trial)
IRCT registration information
IRCT registration number: IRCT20200107046039N1
Registration date: 2020-06-09, 1399/03/20
Registration timing: registered_while_recruiting

Last update: 2020-06-09, 1399/03/20
Update count: 0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
Babak Babakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1560
Email address
bbabakhani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone in patients with lumbar discopathy in terms of quality of life
Public title
Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone on lumbar discopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain With lower limb radicular symptoms Spinal MRI indicates inter-vertebral disc(s) protrusion of L3-L4, L4-L5 or L5-S1 Failure of conservative treatments and peri-root injection
Exclusion criteria:
Previous back surgery Coagulation disorder Drug abuse Known non-treated psychiatric disorders Lower extremity weakness Sphincter disorder Disc protrusion more than one third of anterior-posterior spinal column in MRI Sequestration or extrusion of inter-vertebral disc in MRI
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by computer randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In group one, after prep and drape, patients receive intradiscal nucleoplasty of responsible disc(s) after local anesthesia under C-Arm vision in prone position using diode laser. Patients in group two receive such a treatment, but before removal of intradiscal needle, 2 ml of 45 micro-gram/ml Ozone will be injected into the disc with a speed less than 0.5 ml/sec. The surgeon will be aware of the group allocation, while the patient, researcher and analyzer remain blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Neuroscience Institute, Tehran University of Medical Sciences
Street address
Reyhaneh Building, Emam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2019-08-08, 1398/05/17
Ethics committee reference number
IR.TUMS.NI.REC.1398.005

Health conditions studied

1

Description of health condition studied
Lumbar radiculopathy, Lumbar discopathy, Low back pain
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy

2

Description of health condition studied
lumbar radiculopathy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region

Primary outcomes

1

Description
Numeric Rating Scale (NRS): An 11-point numeric rating scale is a simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain).
Timepoint
Before intervention, one, six and 12 month after intervention
Method of measurement
An 11-point numeric rating scale is a simple tool that tells us the patient's perceived intensity of pain. Patients are given a scale from 0 (no pain) to 10 (worst pain) and they select a number.

2

Description
(Oswestry Disability Index (ODI): self-filled questionnaire by patient which indicates disability from low back pain.
Timepoint
Before intervention, one, six and 12 month after intervention
Method of measurement
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Secondary outcomes

empty

Intervention groups

1

Description
The patient receives intradiscal nucleoplasty of responsible disc(s) in prone position using diode laser PW 3.5 to 5 W 1200 to 1500 j.Before removal of intradiscal needle, 2 ml of ozone 45 micro-gram/ml will be injected into the disc with a speed less than 0.5 ml/sec. Dressing of puncture site will be done.
Category
Treatment - Surgery

2

Description
Control group: The patient receives intradiscal nucleoplasty of responsible disc(s) in prone position using diode laser PW 3.5 to 5 W 1200 to 1500 j. The needle will be removed and dressing of puncture site will be done.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Imam Khomeini Hospital, Tehran
Full name of responsible person
Babak Babakhani
Street address
Reyhaneh Building, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1560
Email
drbabakhani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6692
Email
gsia@tums.ac.ir
Web page address
https://www.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
Babak Babakhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pain management
Street address
Reyhaneh Building, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1560
Email
drbabakhani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Babakhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pain management
Street address
Reyhaneh Building, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1560
Email
drbabakhani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Babakhani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pain
Street address
Reyhaneh Building, Brain and Spinal Cord Injury Research Centre,Emam Khomeini Hospital, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1560
Fax
Email
drbabakhani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Collected deidentified IPD, IPD collected for the primary outcome measure (NRS and ODI)
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Medical research and studies
From where data/document is obtainable
Reyhaneh Building, Brain and Spinal Cord Injury Research Centre,Emam Khomeini Hospital, Keshavarz Blvd., Tehran Dr Babak Babakhani Email: bbabakhani@sina.tums.ac.ir
What processes are involved for a request to access data/document
Sending Email
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