Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study
Recruiting now · Not applicable
Conditions studied: Hirayama Disease
In brief
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
Key facts
- Study ID
- NCT05959980
- Run by
- All India Institute of Medical Sciences
- People needed
- 80
- Starts
- 2023-10-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-01-30
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All the following:
- Age ≥ 18 years
- Patients with Hirayama disease as per the following criteria (All of the following) (16):
- 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.
- Disease duration of ≤4 years
- Progression of clinical symptoms in the past six-months
You may not qualify if…
- Any of the following:
- Refusal to consent for randomization
- Not willing to come for three- and six-months follow-up
Where it is running
- Deepti Vibha — New Delhi, National Capital Territory of Delhi, India (enrolling)
Full record on ClinicalTrials.gov
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