Study and investigate the therapeutic effects of laser disc decompression in disc herniation
Design
The present clinical study was performed on 58 patients referred to the hospital from 2019 to 2020 who underwent percutaneous laser disc decompression(PLDD). Which included all eligible people over the age of 18 who met The Inclusion & Exclusion Criteria
Settings and conduct
Operating Room.
Blinding has not been done.
The present clinical trial has been done on 58 patients underwent PLDD. Patients were treated with PLDD according to the protocol and were monitored before and after treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria: Eligible patients are patients over 18 years of age with radiologic compact disc herniation and lumbosacral radicular syndrome lasted for 6-8 weeks or herniated segment should be less than 1/3 of the spinal canal based on the patient's MRI or CT-Scan. They were treated with PLDD according to the treatment protocol and were monitored before and after treatment using the visual analogue scale (VAS). We also excluded all the patients who have had Cauda Equina syndrome, previous spine surgery at the same disk level, spondylolisthesis, spinal stenosis, pregnancy, and severe physical and mental illness over the past year
Intervention groups
microdiscectomy was performed by an ipsilateral approach with retraction of mid-line paravertebral muscles without bone removal or with small bone removal and Displacement of the herniated disc through the transflaval. In PLDD, laser energy was sent using an optical fiber inserted through a 18G needle inserted into the pulposus nucleus via an articular graft from the posterolateral side. The procedure was performed with local anesthesia without the need for an anesthesiologist. Eventually, as the nucleus of the disk drains, the pressure on the nerve was reduced.
Main outcome variables
VAS Before VAS After
General information
Reason for update
Acronym
Percutaneous Laser Disc Decompression Trial
IRCT registration information
IRCT registration number:IRCT20200807048332N1
Registration date:2020-10-14, 1399/07/23
Registration timing:retrospective
Last update:2020-10-14, 1399/07/23
Update count:0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
ُSeyed Ghavam Shafagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2238 6159
Email address
ghshafagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-27, 1398/03/06
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
2019-05-27, 1398/03/06
Actual recruitment end date
2020-04-29, 1399/02/10
Trial completion date
2020-04-29, 1399/02/10
Scientific title
Effects of Laser Disc Decompression in Patients with Lumbar Disc Herniation: A Clinical Trial
Public title
Using therapeutic laser for treating herniated intervertebral disc
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible patients were patients over 18 years of age with radiologic Compact Disc herniation
Lumbosacral radicular syndrome lasted for 6-8 weeks
Herniated segment should be less than 1/3 of the spinal canal based on the patient’s MRI or CT-Scan
Exclusion criteria:
All the patients who have had Cauda Equina syndrome
Previous spine surgery at the same disk level
Pregnancy
Spinal stenosis
spondylolisthesis
Severe physical and mental illness over the past year
Age
From 49 years old to 77 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Actual sample size reached:
58
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA University of Medical Sciences ethical committee
Street address
Etemad Zadeh Street
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.AJAUMS.REC.1399.125
Health conditions studied
1
Description of health condition studied
Herniated Disc
ICD-10 code
M50
ICD-10 code description
Cervical disc disorders
2
Description of health condition studied
Herniated Disc
ICD-10 code
M51
ICD-10 code description
Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders
3
Description of health condition studied
Herniated Disc
ICD-10 code
G55
ICD-10 code description
Nerve root and plexus compressions in diseases classified elsewhere
Primary outcomes
1
Description
The cost of treatment
Timepoint
At the first of the study
Method of measurement
Payments
2
Description
Comparison The Pain and Disability before and after the Procedure
Timepoint
Before and After the procedure
Method of measurement
Verbal and Visual Analogue Scale By stimulating the pain, we ask the patient to give us a score from 0 to 10, and from the patient's facial expression
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The present clinical study was performed on 58 patients referred to the hospital from 2019 to 2020 who underwent percutaneous laser disc decompression(PLDD). Inclusion criteria: Eligible patients were patients over 18 years of age with radiologic Compact Disc herniation, and lumbosacral radicular syndrome lasted for 6-8 weeks, or herniated segment should be less than 1/3 of the spinal canal based on the patient’s MRI or CT-Scan. According to the treatment protocol, they were treated with PLDD and were monitored before and after treatment using the Verbal and Visual Analogue Scale (VAS). We also excluded all the patients who have had Cauda Equina syndrome, previous spine surgery at the same disk level, spondylolisthesis, spinal stenosis, pregnancy, and severe physical and mental illness over the past year. PLDD Treatment Protocol: In brief, microdiscectomy was performed by an ipsilateral approach with retraction of mid-line paravertebral muscles without bone removal or with small bone removal and Displacement of the herniated disc through the transflaval. In PLDD, laser energy was sent using an optical fiber inserted through an 18G needle inserted into the pulposus nucleus via an articular graft from the Posterolateral side. The procedure was performed with local anesthesia without the need for an anesthesiologist. Eventually, as the nucleus of the disc drains, the pressure on the nerve was reduced. The patients first located in the prone position. The patients were prepared after prepping and draping, and under the C-Arm X-Ray machines (CARM) guide from the lateral Scottish dog to the desired level of the symptomatic side, needle gage 18 is entered as the tunnel view. After discography and control at the Antero-Posterior and Lateral aspects and ensure that the needle is in the middle of the disc, the fiber (980 nm wavelength and 240-400 µm diode laser) is entered into the needle. Y connector is closed, and then we set the device to 8 Joules and adjust the settings in 0.6-second radiation and 1.2 seconds pause; also, we set the device to 8 watts in active mode, then we press the pedal, and irradiated from 800 to 1400 joules depending on the size of the disc and its level, and usually at every 300 joules, the needles will be pulled up to 2 mm backward or forward to create a larger quadrant. If the patient is found to have radicular pain, the needle will be moved with control by CARM; it is normal to have mild lumbar pain (measuring the pain by pain score). The patient has to be alert and conscious at all stages of the procedure and initially has a slight sedation when asked to move his/her feet during surgery. The surgery is performed by an experienced neurosurgeon and was observed by other experts
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomeini Hospital
Full name of responsible person
Dr Sharif Najafi
Street address
Keshavarz Boulevard and west of Palestine Street and east of Vesal Street and north of Taleghani Street, north of Italy Street