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Study aim
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1- Determining the average pain score and dysfunction score of patients based on visual analog scale in patients with temporomandibular joint (TMJ) disorders in hypertonic dextrose prolotherapy and physiotherapy group before entering the study and then one, three and 6 months after the intervention.
2- Determining the average maximum mouth opening and the presence/absence of click in the joint in patients with TMJ disorders in the group of hypertonic dextrose prolotherapy and physiotherapy, before entering the study and then one, three and 6 months after the intervention.
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Design
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A controlled, cross-over, single-blind, randomized, phase 2 clinical trial on 34 patients. Block randomization was used for randomization.
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Settings and conduct
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The intended study will be conducted in patients referred to Imam Reza (AS) hospital. The patients are divided into two intervention and control groups.
It is in the form of 1 session for each involved joint using a 30 size needle and a 3 ml syringe with the combination
0.75 ml of 50% dextrose, 0.75 ml of sterile distilled water and 1.5 ml of 2% lidocaine are injected in the area around the TMJ and in the neurofascial path under ultrasound guidance. In the control group, 10 sessions of routine physiotherapy are performed.
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Participants/Inclusion and exclusion criteria
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Consciously and voluntarily in all patients between 20 and 65 years of age who have TMJ disorders and have no signs of infection, previous surgery, tumor in the target joint, and have a history of diabetes, coagulation or rheumatological disorders, or steroid use within 1 month. Not recent or during pregnancy or breastfeeding.
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Intervention groups
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in the intervention group, hypertonic dextrose solution will be injected and in the control group, physiotherapy will be done.
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Main outcome variables
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the pain; Dysfunction; Joint range of motion with VAS