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IRCT20130523013442N36 IRCT 2024-04-12 Shahid Beheshti University of Medical Sciences Comparison of percutaneous hyaluronidase injection, percutaneous laser disc decompression (PLDD) and percutaneous ozone injection in radiculopathy of patients with herniated lumbar disc. Comparison of percutaneous intradiscal hyalase injection, percutaneous intradiscal ozone injection, and percutaneous laser disc decompression in radiculopathy of patients with herniated lumbar disc 2024-02-26 anticipated 30 Complete https://irct.ir/trial/72628 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this clinical trial study, 30 patients with a diagnosis of lumbosacral radiculopathy will be included in the study randomly .For random allocation of individuals in the study groups, the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including two people in in each of the three groups with a ratio of 1:1:1 will be used. Random allocation software (RAS) will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with three types of cards which are identified by the letters A (intradiscal laser recipient group), B (hyaluronidase recipient group) and C (intradiscal ozone recipient group). Cards will be recorded and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined, Blinding description: In this study, the researcher, the data analyst, and the outcome evaluator are kept blind and are not aware of the intervention performed on each group of patients, and only the final data are assigned to the first, second, and third groups of random numbers. Due to the different intervention in the three groups, it is not possible to blind the participants and the Care provider. 3 Lumbosacral radiculopathy. Intervention 1: Intervention group: includes 10 patients who are treated with intradiscal laser (VELAS, 30W, 980 nm, diode laser) and a maximum of 1000 joules of energy was used. Immediately after exiting the Chiba needle (15 cm, G20) from the disc, 3 cc of 2% lidocaine and 40 mg of triamcinolone are injected infraneurally. Intervention 2: Intervention group: includes 10 patients who are treated with 1500 mg of hyaluronidase inside the nucleus pulposus. Immediately after exiting the Chiba needle (15 cm, G20) from the disc, 3 cc of lidocaine 2% and 40 mg of triamcinolone are injected infraneurally. Intervention 3: Intervention group: includes 10 patients who are treated with a maximum of 10 cc of ozone with a concentration of 40 µg/ml (intradiscal injection). Immediately after exiting the Chiba needle (15 cm, G20) from the disc, 3 cc of lidocaine 2% and 40 mg of triamcinolone are injected infraneurally. Yes - There is a plan to make this available What will be shared: All the data of people participating in this study can be shared after deidentifying people. When: The access period starts one year after the results are published To whom: Data of this study will be available to researchers working in academic and scientific institutions Conditions: If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers. Where to obtain: By sending an email to alin7093@gmail.com How to obtain: The given request should contain information about his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant. Comments:
public Ali Nazari Nodoushan
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 alin7093@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with lumbar radiculopathy whose duration of symptoms is between 6 weeks and 6 months and has not responded well to conservative treatment (NSAIDs, physiotherapy or epidural injection) The minimum VAS score of all participants is considered 5. In MRI, confirmed disc herniation in one level with grade 1A, 2A, 1B, 2B based on the Michigan State University (MSU) classification 25 years 65 years Both Cauda equina syndrome The presence of any defect in motor function. Major neurological deficit Allergy to bovine proteins in patient treated with hyaluronidase​ Pregnancy and breastfeeding Spondylodiscitis Spondylolisthesis Spinal canal stenosis more than 50% Reduction of disc height Previous history of spine surgery M54.16 Radiculopathy, lumbar region Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: includes 10 patients who are treated with intradiscal laser (VELAS, 30W, 980 nm, diode laser) and a maximum of 1000 joules of energy was used. Immediately after exiting the Chiba needle (15 cm, G20) from the disc, 3 cc of 2% lidocaine and 40 mg of triamcinolone are injected infraneurally. Intervention group: includes 10 patients who are treated with 1500 mg of hyaluronidase inside the nucleus pulposus. Immediately after exiting the Chiba needle (15 cm, G20) from the disc, 3 cc of lidocaine 2% and 40 mg of triamcinolone are injected infraneurally. Intervention group: includes 10 patients who are treated with a maximum of 10 cc of ozone with a concentration of 40 µg/ml (intradiscal injection). Immediately after exiting the Chiba needle (15 cm, G20) from the disc, 3 cc of lidocaine 2% and 40 mg of triamcinolone are injected infraneurally. Assessment of lumbar pain. Timepoint: At the beginning of the study (before intervention) and 4 weeks, 12 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS). Evaluation of pain, function and return to activity. Timepoint: At the beginning of the study (before intervention) and 4 weeks, 12 weeks and 24 weeks after the intervention. Method of measurement: Using the Modified Macnab questionnaire. Assessment of the patient's disability in daily living. Timepoint: At the beginning of the study (before intervention) and 4 weeks, 12 weeks and 24 weeks after the intervention. Method of measurement: Using the Oswestry low back disability (ODI) questionnaire. Laser Application in Medical Sciences Research Center(LAMSRC) Shahid Beheshti University of Medical Sciences Approved 2023-05-31 Research Ethics Committees of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)