Sono-guided Oxygen-ozone and corticosteroid therapy for the treatment of musculoskeletal Pain in physical and rehabilitation medicine: Interventional pain management for Carpal tunnel syndrom: A prospective, randomized, double-blind, Multicente

The effect of topical corticosteroid and ozone injection under ultrasound guidance in the treatment of carpal tunnel syndrome

A phase 3, umulticenteral, randomized, positive controlled, double blinded, clinical trial with a parallel group design of 50 patients, followed up one week and two months after injection

Department of Physical Medicine and Rehabilitation of Shohada Hospital and Imam Reza Hospital affiliated to Tabriz University of Medical Sciences and Physiotherapy and Rehabilitation Physics Department of Rasoul Akram Medical Center affiliated to Iran University of Medical Sciences

Having moderate or Severe moderate carpal tunnel syndrome confirmed by Electrodiagnosis (EDX) criteria, Unwillingness to undergo surgery; The presence of symptoms of severe atrophy or severe CTS in EMG-NCV, Contraindications for corticosteroid injection, Treatment of CTS with surgery or corticosteroid injection in the last 6 months, Traumatic or neoplastic origin of symptoms, Not having satisfaction for injection.

Topical ozone injection group: 2cc ozone 20μg/L Corticosteroid injection group: 1cc triamcinolone 40mg + 1cc normal slain

Visual Analogue Scale Boston scale

Tabriz University of Medical Sciences and Iran University of Medical Sciences

A simple random method for randomization will be used and individuals (patients) will form random units. A random sequence will be generated using RAS software. A central randomization method will be used to conceal random allocation. The random sequence will be created by the statistician and will be available to her. The doctor will be connected to the statistician by telephone or text message and will ask him or her about the random allocation of the participant to the specific group.

This randomized, double-blind randomized clinical trial is a multi-centered patient with a positive control group and will be performed in four groups of patients with musculoskeletal disorders by four physicians and physicians in four different health centers. All patients will be given enough information about the properties of ozone and corticosteroid injections, possible side effects, method and duration of testing, and the likelihood of having a candidate from one of the two treatments. All patients will be asked to sign a written informed consent form.In order to blind the patient, the doctor will prepare the injection material in the syringe, and will cover the syringes with an aluminum sheet to avoid being aware of the type of injection. It should be noted that dilution of corticosteroid and normal salon will be done to equalize the volume of all three injectable solutions. Patients in each group will be evaluated by a physical medicine and rehabilitation specialist who is not aware of the type of injection, before the injection, one week after the injection and two months after the injection, and the rate of change between the two groups will be compared at different times. It should be noted that in each center all injections are performed by a constant person (a physical medicine and rehabilitation specialist). Using three-flood coded questionnaires, where the first flood represents the group, the second flood indicates the time of the measurement of the outcome and the third flood represents the patient's code, the analyst will also be unaware of the allocation of people to the treatment groups.