About this trial
The goal of this clinical trial\] is to compare cervical collar versus neck stabilization surgery in diagnosed patients of Hirayama disease who have been reporting worsening of problems in the past six months. The main question\[s\] it aims to answer are:
• Is cervical stabilization surgery (Posterior cervical fixation) superior to conservative management in the form of cervical collar placement in patients with progressive Hirayama disease, observed at six months after intervention
Participants will have equal chance to:
* Undergo cervical fixation surgery * Cervical collar management The investigators will study and compare the efficacy of both treatments upto six months after intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion)
Progressive course, or initial progression followed by stationary course; and
No evidence of a compressive lesion of the spinal cord.
Disqualifiers
Refusal to consent for randomization
Not willing to come for three- and six-months follow-up
Trial design
Parallel
Treatments tested in this trial
Posterior cervical fixation surgery
Procedure/SurgeryThese patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
Odom's criteria score at six months
Secondary outcomes
Odom's criteria score at three months
interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord
Electrophysiological and grip strength
Sponsors and contacts
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