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IRCT20220620055227N1 IRCT 2022-09-03 Artesh University of Medical Sciences Evaluation of the effectiveness of neurofacial prolotherapy dextrose ontemporomandibular joint disorders Evaluation of the effectiveness of neurofacial prolotherapy dextrose ontemporomandibular joint disorders 2022-09-23 anticipated 34 Complete https://irct.ir/trial/64302 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: First, blocks of 4 are prepared, each block includes 2 patients for the control group and 2 patients for the intervention group. For example, in one block, the first two patients may be placed in the control group and the next two patients in the intervention group. And in another block, the patients may be divided one by one, Blinding description: Every patient is examined in the first visit by a doctor who is an expert in the field of the disease and is unaware of the patient's therapeutic intervention group, and the follow-up and recording of changes in the examination after the intervention is also recorded by the same doctor. It is the result of the intervention, it is requested not to talk about the treatment done. Also, the analysis of statistical data is done by an analyst who does not know the intervention group of patients. 1-2 Temporomandibular joint pain. Intervention 1: Intervention group: The intended study will be conducted in patients referred to Imam Reza (AS) Hospital. The patients are divided into two intervention and control groups. In the prolotherapy group, the intervention is in the form of 1 session for each involved joint using a measuring needle. 30 and a 3 ml syringe with a combination of 0.75 ml of 50% dextrose, 0.75 ml of sterile distilled water and 1.5 ml of 2% lidocaine is injected in the area around the temporomandibular joint and in the neurofascial path under ultrasound guidance. Intervention 2: Control group: under 10 regular sessions of physiotherapy of the temporomandibular joint area involved by the routine modality of physiotherapy in each session: heat therapy with IR light for 10 minutes, electrotherapy by TENS with an analgesic approach for 5 minutes, US with pulse and high frequency method for 5 minutes. All Therapeutic modalities are the creation of a modern medical engineering company. 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 There is no more information
public Sepanta Hatam
AJA university of medical science Etemad zade Ave, Fatemi Street, Amirabad
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 sepanta3v@yahoo.com Artesh University of Medical Sciences scientific Sepanta Hatam
AJA university of medical science Etemad zade Ave, Fatemi Street, Amirabad
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 sepanta3v@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) All patients with temporomandibular joint disorders Informed consent of the patient and willingness to participate in the study 20 years 65 years Both Active infection in the temporomandibular joint Pregnancy and breastfeeding History of surgery in the joint itself A history of fracture or dislocation in the temporomandibular joint History of tumor and malignancy in place Coagulation disorders Use of systemic corticosteroid drugs in the last month diabetes Systemic rheumatological disorders Taking anticoagulant drugs Treatment - Drugs Treatment - Devices Intervention group: The intended study will be conducted in patients referred to Imam Reza (AS) Hospital. The patients are divided into two intervention and control groups. In the prolotherapy group, the intervention is in the form of 1 session for each involved joint using a measuring needle. 30 and a 3 ml syringe with a combination of 0.75 ml of 50% dextrose, 0.75 ml of sterile distilled water and 1.5 ml of 2% lidocaine is injected in the area around the temporomandibular joint and in the neurofascial path under ultrasound guidance. Control group: under 10 regular sessions of physiotherapy of the temporomandibular joint area involved by the routine modality of physiotherapy in each session: heat therapy with IR light for 10 minutes, electrotherapy by TENS with an analgesic approach for 5 minutes, US with pulse and high frequency method for 5 minutes. All Therapeutic modalities are the creation of a modern medical engineering company. Pain intensity based on visual analog scale after intervention. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month, then 3 and 6 months after the intervention. Method of measurement: Visual analog scale (VAS) questionnaire. Severity of functional impairment based on visual analog scale after intervention. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month, then 3 and 6 months after the intervention. Method of measurement: Visual analog scale (VAS) questionnaire. The maximum distance between teethUpper and lower bite that can be done by the patientIt can be done without causing pain, after the intervention.Community Verified icon. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month, then 3 and 6 months after the intervention. Method of measurement: Ruler in mm. Additional sound found during opening and closing of the mouth in the temporomandibular joint. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month, then 3 and 6 months after the intervention. Method of measurement: During the doctor's examination. Artesh University of Medical Sciences Approved 2022-06-19 Research Ethics Committees of AJA University of Medical Sciences No. 15, azadeh Ave., South Bahar street., west fedos blvd Tehran Tehran Iran (Islamic Republic of)