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IRCT20200107046039N1 IRCT 2020-06-09 Tehran University of Medical Sciences Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone on lumbar discopathy OLINT (Ozone Laser Intradiscal Nucleoplasty Trial) Therapeutic effects of laser assisted intradiscal nucleoplasty with and without adjuvant intradiscal ozone in patients with lumbar discopathy in terms of quality of life 2020-02-20 anticipated 32 Complete https://irct.ir/trial/45132 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups by computer randomization, 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. N/A Condition 1: Lumbar radiculopathy, Lumbar discopathy, Low back pain. Condition 2: lumbar radiculopathy. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Collected deidentified IPD, IPD collected for the primary outcome measure (NRS and ODI) When: starting 6 months after publication To whom: people working in academic institutions Conditions: Medical research and studies Where to obtain: Reyhaneh Building, Brain and Spinal Cord Injury Research Centre,Emam Khomeini Hospital, Keshavarz Blvd., Tehran Dr Babak Babakhani Email: bbabakhani@sina.tums.ac.ir How to obtain: Sending Email Comments:
public Babak Babakhani
Reyhaneh Building, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1560 drbabakhani@yahoo.com Tehran University of Medical Sciences scientific Babak Babakhani
Reyhaneh Building, Imam Khomeini Hospital, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1560 drbabakhani@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 15 years 70 years Both 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 M51.16 M54.16 Intervertebral disc disorders with radiculopathy Radiculopathy, lumbar region Treatment - Surgery Treatment - Surgery 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. 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. 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. (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. Tehran University of Medical Sciences Approved 2019-08-08 Ethics committee of Neuroscience Institute, Tehran University of Medical Sciences Reyhaneh Building, Emam Khomeini Hospital, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)