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Study aim
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Effectiveness of tizanidine drug in improving spasticity in patients with diffuse axonal injury related to brain injury
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Design
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Patients in the intervention group will use tizanidine 4 mg tablets twice a day, and the control group will use placebo tablets twice a day, which have the same shape and appearance as tizanidine tablets. None of the patients will receive drugs that have muscle relaxant effects, such as baclofen or methocarbamol, during the study. The amount of muscle spasm using the modified Ashworth scale at the time of admission and discharge from the hospital, and the final outcome of the patients (discharge or death) will also be calculated and recorded for each patient.
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Settings and conduct
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Shahid Dr. Rahnamon Hospital in Yazd
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Participants/Inclusion and exclusion criteria
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Patients aged 15 to 60 years and diagnosed with diffuse axonal damage based on the diagnosis of a neurosurgery specialist and imaging evidence, who do not have chronic liver and kidney disease and have the ability to receive medication orally or through a nasogastric tube.
Conditions of non-entry: lack of informed consent by the patient's first-degree relatives, spinal cord injury, penetrating head injury, previous traumatic brain injury, kidney failure, pregnancy, history of allergy to tizanidine, and patients whose treatment plan changes during the study, for example, the need for surgery to find, is
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Intervention groups
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The intervention group received tizanidine tablets and the control group received placebo tablets
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Main outcome variables
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The primary outcome measured includes The Modified Ashworth Scale (MAS), which is evaluated in this measure of changes in muscle tone. The secondary outcome measured is The Disability Rating Scale (DRS) score. In this measure, key aspects of disability are assessed, including the ability to open the eyes, the ability to communicate, and motor response.