Cervical spondylotic myelopathy
Conditions
Sponsors
Kawaguchi Yoshiharu
Tohda Chihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those whose age at consent date is 40 years - 85 years. 2) Those who can participate in the inspection conducted on the University of Toyama Sugitani Campus. 3) Those who meet the diagnostic criteria for cervical spondylotic myelopathy by physical examination. 4) Those who have a cervical spine JOA score of 8 points or more and 15 points or less at the time of screening. 5) Those who agree to provide blood samples for clinical examination. 6) The person can take the test drug, and the person or family member can manage to intake the drug. 7) Those who agree not to make extreme changes in lifestyle such as exercise habits and eating habits during the test period.
Exclusion criteria
Exclusion criteria: 1) Patients who do not agree. 2) Those who was in uncontrolled and clinically problematic health conditions (diabetes, hypertension, thyroid / endocrine disorders, congestive heart failure, angina, heart disease, cancer risk such as breast cancer, uterine cancer, or ovarian cancer, gastrointestinal disease, dialysis or renal dysfunction, etc.) within 3 months of consent. 3) Those with a history of alcohol and substance abuse. 4) Those who are participating in other intervention clinical trials. 5) Those with a cervical spinal cord JOA score of 16 points or more at the time of screening and very mild cervical spondylotic myelopathy. 6) Those who have a cervical spinal cord JOA score of 7 points or less at the time of screening and who have serious cervical spondylotic myelopathy and who are judged to require early surgery. 7) In addition, those who are judged by the researcher to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Calculate the total score of the cervical spine JOA score (Japan Orthopedic Cervical Myelopathy Treatment Criteria) and JOACMEQ (JOA Cervical Myelopathy Evaluation Questionnaire), and calculate the total score before, 12 weeks (3 months), 24 weeks (6 months) after administration. Calculate the amount of change in the score at the time of and compare between the groups. 2) Physical examination findings (number of 10-second tests, grip strength) before administration, before administration, 12 weeks (3 months) and 24 weeks (6 months) after administration. Calculate the amount of change in the score and compare between the groups. 3) Calculate the total score of EQ-5D (Japanese version EuroQol), and the amount of change in the score before administration, before administration, 12 weeks (3 months) and 24 weeks (6 months) after administration. Calculate the amount of change in the score and compare between the groups. 4) Calculate VAS, and the amount of change in the score before administration, before administration, 12 weeks (3 months) and 24 weeks (6 months) after administration. Calculate the amount of change in the score and compare between the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Simple X-ray, MRI | — |
Contacts
Public ContactChihiro Tohda
University of Toyama
Outcome results
None listed