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IRCT20200807048332N1 IRCT 2020-10-14 Artesh University of Medical Sciences Using therapeutic laser for treating herniated intervertebral disc Percutaneous Laser Disc Decompression Trial Effects of Laser Disc Decompression in Patients with Lumbar Disc Herniation: A Clinical Trial 2019-05-27 anticipated 75 Complete https://irct.ir/trial/50187 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Condition 1: Herniated Disc. Condition 2: Herniated Disc. Condition 3: Herniated Disc. 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Ethical issues
public Seyed Ghavam Shafagh
No 8, 4th east Ave, 24 metri Blvd, sadat abad
Tehran Iran (Islamic Republic of) 1997758540 +98 21 2238 6159 ghshafagh@gmail.com Iran University of Medical Sciences scientific Mohammad Reza Boustani
No 8, 4th east Ave, 24 metri Blvd, sadat abad
Tehran Iran (Islamic Republic of) 1997758540 +98 21 2238 6159 Dr.boustani@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 49 years 77 years Both 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 M50 M51 G55 Cervical disc disorders Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders Nerve root and plexus compressions in diseases classified elsewhere Treatment - Surgery 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 The cost of treatment. Timepoint: At the first of the study. Method of measurement: Payments. 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. Artesh University of Medical Sciences Approved 2020-10-12 AJA University of Medical Sciences ethical committee Etemad Zadeh Street Tehran Tehran Iran (Islamic Republic of)