A comparison between effectiveness of intramuscular ozone gas injection in paravertebral muscles with subcutaneous ozone gas injection in patients with lumbosacral spinal canal stenosis - a randomized clinical trail

A comparison between effectiveness of intramuscular ozone gas injection in paravertebral muscles with subcutaneous ozone gas injection in patients with lumbosacral spinal canal stenosis

The research is a randomize double blind clinical trial

The patients who had lumbosacral canal stenosis were selected from physical medicine and rehabilitation clinics of Shiraz University of Medical Sciences then patients were divided into two groups and after obtaining written consent the study was begun .In the group A ozone gas was injected into paravertebral muscles and in the group B, ozone gas was injected subcutaneous, and finally, their effect in reducing patients' pain, improving function and quality of life were measured.

Inclusion criteria: completion and signing of the consent form Presence of pain and other clinical symptoms of lumbar sacral stenosis in the last six months that did not respond to conservative treatments Age between 75-35 years and absence of any disease around the spine Non-inclusion criteria: Favism; infection involving lumbar spinal (brucella) Diabetes mellitus Rhumatological disorder(lupuse, gout) BMI more than 41Pregnancy Malignancy Liver disease sensitivity reaction to test drug Malnutrition Peripheral neuropathy Bleeding disorder Galactosemia Radiculopathy Inability to communicate and complete questionnaires

Group A: subcutaneous injection of 2 cc of 25 ml/ug ozone gas in the area of back pain at an angle of 45-degree to the sagittal plate whit 25 needle. Group B: injection of 2 cc of 25 ml/ug ozone gas at the paravertebral muscles at an angle of 90-degre to the sagittal plate 2cm bilateral from the lumbar spinous processes. whit 22 needle

Pain level, patient performance and daily routines quality of life

Blocked randomization method is used to randomize the study. The list is sorted by the computer with the same size block and the clinic secretary divides the patients based on the list

Considering that the patient is unaware of the technique of performing the project and does not see the type of needle and the same drug is injected for him and the general conditions of the procedure are the same for both groups and only the technique of doing it is different: the patient, the questioner, the statistical analyst. are blind Only the performing doctor knows what kind of procedure he has performed. (The patient is blind). Clinical Caregiver: We teach the person who cares and examines how to complete the questionnaire. This person has no knowledge of the type of patient intervention. In this study, we do not have the researcher and the researcher, because the researcher gives both his studies and informs about the type of intervention in each group. Message evaluator: Questionnaires are completed to a person who is not informed about the interventions and determines the amount of pain reduction and performance increase in each person according to the questionnaire. Analysts: Finally, after completing and collecting all the information, the questionnaires are given to the person to check the information, that this person is not involved in any of the steps and how the intervention is divided.