Comparison of percutaneous intradiscal hyalase injection, percutaneous intradiscal ozone injection, and percutaneous laser disc decompression in radiculopathy of patients with herniated lumbar disc

The purpose of this study is to compare the effectiveness of percutaneous laser disc decompression (PLDD), intradiscal ozone injection and intradiscal hyaluronidase injection in reducing pain and improving function of patients with radiculopathy following lumbar intervertebral disc herniation.

A controlled, parallel-group, double blind, randomized, phase 3 clinical trial on 30 patients. Random allocation software is used for randomization.

Outcome assessor, statistician and the researcher are all blind to treatment group allocation. Subjects will be randomly allocated in 3 groups. The study will take place in Modava pain clinic, Tehran.

Patients with lumbar radiculopathy whose duration of symptoms is between 6 weeks and 6 months and did not respond properly to conservative treatments, the minimum VAS questionnaire score of participants is 5, and in MRI, confirmed disc herniation in one level with grade 1A, 2A, 1B 2B based on the MSU classification. Exclusion criteria include cauda equina syndrome, major neurological defects, pregnancy and breastfeeding, spondylodiscitis, spondylolisthesis, spinal canal stenosis, previous history of spine surgery.

Intervention group 1: 10 patients are treated with intradiscal laser and a maximum of 1000 joules of energy is used. Intervention group 2: 10 patients are treated with 1500 mg of hyaluronidase inside the nucleus pulposus. Intervention group 3: A maximum of 10 cc of ozone with a concentration of 40 µg/ml is used for intradiscal injection. In all groups, 3 cc of 2% lidocaine and 40 mg of triamcinolone are injected immediately after the needle exits the disc in the infraneural position.

Assessment of lumbar pain, assessing the patient's performance and disability in daily tasks.

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

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.

All the data of people participating in this study can be shared after deidentifying people.

The access period starts one year after the results are published

Data of this study will be available to researchers working in academic and scientific institutions

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.

By sending an email to alin7093@gmail.com

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.