This study aims to determine the clinical effects of percutaneous disc decompression with laser in the treatment of lumbar discopathy compared to routine drug treatments.
Design
Clinical trial with a control group, with factorial groups, and a blind strain, on 36 patients
Settings and conduct
The study will be conducted in the form of a thesis of the Department of Neurosurgery of the University of Medical Sciences on the target population of all patients referred to Imam Reza Hospital clinic with radicular pain caused by intervertebral disc herniation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Age 35-70 years
2) Symptoms of radicular pain in the lower limbs
3) Lumbar disc herniation by CT scan, magnetic resonance imaging (MRI) or myelogram
4) No improvement after 3 months of conservative treatment
Exit criteria:
1) Patients with previous spinal surgery
2) cauda equina syndrome
3) Bone disorders
4) Generalized bulging disc
5) Nervous disorders (movement disorders, urinary and fecal incontinence)
6) Pregnancy
7) Any history of coagulopathy
8) reducing the height of the disc by more than 50%
Intervention groups
Patients in the intervention group, after determining the affected areas of the lumbar spine, taking a history, physical examination, imaging such as MRI, CT scan and electromyography - nerve conduction velocity (EMG-NCV), in an outpatient setting, with injection A one-step needle into the disc space will be treated. Disc material is not removed. Instead, the nucleus pulposus will be vaporized by laser. When finished, the tip of the needle should be in the center of the disc.
Analgesic treatment is prescribed to both intervention and control groups in the same way.
Main outcome variables
PLDD as an alternative treatment for patients with lumbar disc herniation can be performed in an outpatient setting with rapid recovery and return to daily routine.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231121060129N1
Registration date:2023-12-11, 1402/09/20
Registration timing:prospective
Last update:2023-12-11, 1402/09/20
Update count:0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Aydin Enbesati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3440 2199
Email address
aydinenbesaty86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the clinical effects of percutaneous laser disc decompression in the treatment of Lumbar Intervertebral Disc
Public title
Laser therapy in lumbar discopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age 35-70 years
2) Symptoms of radicular pain in the lower limbs
3) Confirmation of lumbar disc herniation with CT scan, magnetic resonance imaging (MRI) or myelogram
4) No improvement after 3 months of conservative treatment
Exclusion criteria:
1) Patients with a history of previous spinal surgery
2) cauda equina syndrome
3) Bone disorders
4) Generalized disc bulging
5) Nervous disorders (movement disorders, urinary and fecal incontinence)
6) Pregnancy
7) Any history of coagulopathy
8) reducing the height of the disc by more than 50%
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The target population includes all patients referred to the Imam Reza Hospital clinic with radicular pain caused by intervertebral disc herniation. Subjects are included in the study by considering the entry and exit criteria through non-random sampling. Then they are divided into intervention and control groups using RAS software using random block method with 2 and 4 blocks. Flow chart (Loss to follow up) will be mentioned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
tabriz
Province
East Azarbaijan
Postal code
3692588521
Approval date
2023-10-04, 1402/07/12
Ethics committee reference number
IR.TBZMED.REC.1402.485
Health conditions studied
1
Description of health condition studied
Lumbar discopathy
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
The Persian version of the Roland-Morris Disability Questionnaire and Oswestry Disability Index is one of the main assessment tools used in the assessment of spinal disabilities. The RDQ has been validated and extensively evaluated in a variety of clinical studies and has been reported to exhibit good psychometric properties. 1 The questions in this questionnaire are designed to provide the physician with information about how Pacemaker pain affects the patient's ability to perform daily tasks.
Timepoint
Investigations are conducted and recorded before the intervention, immediately after the intervention and one week after the intervention.
Method of measurement
The amount of pain is determined using the VAS tool. The VAS tool is in the form of a graduated ruler from 0 to 10, and the patient indicates one of the numbers listed on the ruler according to the intensity of pain from the lowest to the highest.
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group, after determining the affected areas of the lumbar spine, taking a history, physical examination, imaging such as MRI, CT scan and electromyography - nerve conduction velocity (EMG-NCV), in an outpatient setting, with injection A one-step needle into the disc space will be treated. Disc material is not removed. Instead, the nucleus pulposus will be vaporized by laser. Patients are treated with a 1000 J 980 nm diode laser (a product of LaserStar Technologies Corp, manufactured in Germany with a 200 micron fiber) at a power of 5 watts. After sterile skin preparation and dressing, the disc space is identified with the help of a C-arm fluoroscope. The craniocaudal movement of the fluoroscope tube defines the margin of the disc. The fluoroscope tube is rotated obliquely to bring the superior articular process to the midline, and a 7-inch 18-gauge needle is inserted immediately anterior to the superior articular process and superior to the transverse process through a triangular safe zone. Advancement with the C-fluoroscope arm is observed to be strong enough and of good quality to provide an overview of the area. When finished, the tip of the needle should be in the center of the disc.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Agamohammadi Davood
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
tabriz
Province
East Azarbaijan
Postal code
3692588521
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
parvizshahabi@gmail.com
Web page address
Grant name
Investigation of the clinical effects of percutaneous laser disc decompression in the treatment of Lumbar Intervertebral Disc
Grant code / Reference number
71378
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Agamohammadi Davood
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
daghamohamadi@yahoo.com
Web page address
https://imamreza.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Agamohammadi Davood
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
daghamohamadi@yahoo.com
Web page address
https://imamreza.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Enbesati Aydin
Position
neurosurgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
aydinenbesaty86@gmail.com
Web page address
https://imamreza.tbzmed.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