Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia. Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage.
The pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective. Although it is generally thought that syringomyelia is simply an accumulation of CSF from the subarachnoid space, the pathogenesis is likely to be more complex and may involve cellular and molecular processes. The investigators supposed that betaine might play a key role in the pathogenesis of syringomyelia, especially post-traumatic syringomyelia(PTS), and that betaine, as an Osmotic homeostasis-related drug, would protect Osmotic homeostasis in syringomyelia. Primary objectives: This clinical trial aims to evaluate the indications, therapeutic effects and safety of betaine in refractory syringomyelia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Fengzeng Jian
Beijing, Beijing Municipality, China
RECRUITINGASIA Score
American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function， degree of the spinal cord function, motor1-100, sensory 1-224, higher scores mean a better outcome
Time frame: 1 day before and 3 days, 3 months, after drug treatment
syringomyelia remission
syringomyelia remission is defined as ≥ 25% reduction in syringomyelia volume on T2 images at week 12, as compared with that before thalidomide usage
Time frame: 1 day before and 3 days, 3 months, after drug treatment
Electrophysiology results
electromyography and evoked potential; Change of N9-13 From Baseline in Electrophysiology at postoperation
Time frame: 1 day before and 3 days, 3 months, after drug treatment
Visual Analog Scale (VAS)
degree of the pain, 1-10, higher scores mean a worse outcome
Time frame: 1 day before and 3 days, 3 months, after drug treatment
Klekamp and Sammi syringomyelia scale
for evaluating the spinal cord function, higher scores mean a better outcome
Time frame: 1 day before and 3 days, 3 months, after drug treatment
modified Japanese Orthopaedic Association Scores (mJOA)
Motor function， sensory， bladder function；for evaluating the spinal cord function；0-17， higher scores mean a better outcome
Time frame: 1 day before and 3 days, 3 months, after drug treatment
xuanwu syringomyelia scale
for evaluating the spinal cord function, for evaluating the spinal cord function；0-18， higher scores mean a worse outcome
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Time frame: 3 days, 3 months, after drug treatment
Incidence of complications
Incidence of complications
Time frame: 3 days, 3 months, after drug treatment