]>
IRCT20151017024572N15 IRCT 2018-06-04 Tabriz University of Medical Sciences The effect of Oxygen-ozone and corticosteroid therapy for the treatment of Carpal tunnel syndrom PMR 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 2017-08-23 anticipated 50 Complete https://irct.ir/trial/20697 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 carpal tunnel syndrome. Intervention 1: Intervention group: 2cc ozone 20μg / L, around the median nerve with Medial approach as in-plane under ultrasound guidance. Intervention 2: Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc normal slain, around the median nerve with Medial approach as in-plane under ultrasound guidance. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Bina Efrekharsaadat
Physical Medicine & Rehabilitation Research Center, Imam Reza Hospital,Physical Medicine & Rehabilitation Research Center
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 binasadat@yahoo.com Physical Medicine & Rehabilitation Research Center scientific Arash Babaie-Ghazani
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran. Tel: 00982182141297, Fax: 00982188942970
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8214 1612 babaei-ghazani.a@iums.ac.ir Neuromusculoskeletal Research Center, Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Cavernous carpal tunnel syndrome confirmed by Electrodiogenesis (EDX) criteria Severe moderate carpal tunnel syndrome that is proven by EDX criteria The presence of paresthesia or numbness in the median nerve pathway Unwillingness of the patient to undergo surgery SNAP amplitude decrease NCV across wrist smaller than 40 m/sec Peak SNAP latency larger than 3.6 msec CMAP latency larger than 4.2 msec no limit no limit Both The presence of severe atrophic symptoms or severe CTS in EMG-NCV. Contraindications for corticosteroid injection such as corticosteroid allergy and injection site infections CTS treatment with surgery or corticosteroid injection in the last 6 months Traumatic or neoplastic origin of symptoms Not having satisfaction for injection CMAP amplitude absence (CMAP) or the presence of symptoms of fib / psw in tense muscles Signs of Cervical Activated Radiculopathy in Nidal Electromigraphy or Extruded Cervical Discs in MRI G59 Mononeuropathy in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: 2cc ozone 20μg / L, around the median nerve with Medial approach as in-plane under ultrasound guidance. Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc normal slain, around the median nerve with Medial approach as in-plane under ultrasound guidance. Pain score based on Visual Analogue Scale. Timepoint: Before injection, 2 weeks and 8 weeks after injection. Method of measurement: Visual Analogue Scale. The functional limitations and symptoms severity scales on Boston Questionnaire. Timepoint: Before injection, 2 weeks and 8 weeks after injection. Method of measurement: Boston Questionnaire. Clinical Global Impression. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Clinical Global Impression Questionnaire. Patient Global Impression of Improvement. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Patient Global Impression of Improvement Questionnaire. Electromyographic findings. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: Nerve strip. Median nerve cross section. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: sonography. Channel depth. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: sonography. Flexor Retinaculum Thickness. Timepoint: Before injection, 1 weeks and 8 weeks after injection. Method of measurement: sonography. Iran University of Medical Sciences Tabriz University of Medical Sciences Iran University of Medical Sciences Approved 2017-07-08 Iran University of Medical Sciences Hemmat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)