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IRCT20200118046174N1 IRCT 2020-03-20 Tehran University of Medical Sciences The effect of ozone gas on lower back pain The effect of ozone therapy on pain and function of patients with lumbar disc herniation 2020-03-05 anticipated 20 Complete https://irct.ir/trial/45206 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Due to the fact that the treatment was different in the two intervention and control groups, there was no possibility of blinding the participants. Physician helping patients fill out questionnaires and the Physician who checks the MRI blinded. The analyzer was also blinded. 3 Back Pain; Lumbar disc - Lumbar disc herniation. Intervention 1: Intervention group: Injection of ozone at a concentration of 40 mg / DL in the operating room. Intervention 2: Control group: Physiotherapy and drug treatment. Yes - There is a plan to make this available What will be shared: All the study database will be accessible except the participants personal data. When: The database will be accessible 6 months after result publication To whom: The database will be accessible for academic researchers Conditions: Use of database in academic researches is permitted by reference to the source Where to obtain: For database access the request must be sent to farhadmahdavi6889@gmail.com How to obtain: Upon sending an email the request will be reviewed by the hospital research center and will be sent to the applicant academic research center immediately after verification of the identity. Comments:
public Farhad Mahdavi
Imam Khomeini Ave Sina Hospital Orthopedic Department
Tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ +98 21 6312 1297 farhadmahdavi6889@gmail.com Tehran University of Medical Sciences scientific Farhad Mahdavi
Imam Khomeini Ave; Sina Hospital Orthopedic Department
Tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ 63121297 farhadmahdavi6889@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with lumbar disc herniation 18 years 65 years Both Spinal Stenosis History of surgery in the Spine area History of malignancy in the Spine area M51.16 Intervertebral disc disorders with radiculopathy, lumbar region Treatment - Drugs Rehabilitation Intervention group: Injection of ozone at a concentration of 40 mg / DL in the operating room Control group: Physiotherapy and drug treatment Pain. Timepoint: In baseline, 2 weeks 1 month and 3 months after ozone injection. Method of measurement: Visual Analogue Scale. Function. Timepoint: In baseline and 3 months after ozone injection. Method of measurement: Sf36. Regression of herniated disc. Timepoint: In baseline and 3 months after ozone injection. Method of measurement: MSU Classification. Tehran University of Medical Sciences Approved 2018-07-25 Ethics committee of Tehran University of Medical Sciences First floor Building No. 4 Sina Hospital Imam Khomeini Hospita Tehran Tehran Iran (Islamic Republic of)