spondylosis
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with spondylosis at the time of screening and clinically eligible for treatment with NSAIDs (2) Patients who have pain in the upper or lower extremities caused by spondylosis and have been in pain for longer than 3 months prior to screening (3) Patients aged 20 years or older at the time of consent (4) Patients who understand the procedures of this study, can answer questions in Japanese appropriately without assistance, and can give written consent to participate in this study
Exclusion criteria
Exclusion criteria: (1) Patients who have severe pain other than spondylosis at the time of screening and are considered difficult to evaluate (2) Patients with painful bone fractures (3) Patients with serious hepatic, renal, or cardiac diseases that would make it difficult to participate in this study (4) Patients who have Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP) score with 11 points or more for physicians, or with 10 points or more for physicians and 15 points or more for patients, at screening (5) Patients who are judged unsuitable for participation in this study by the principal investigator or sub-investigator at the time of screening or study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Difference in the time required for monitoring activities (average of the total time required for CRF checks) (2) Difference in the number of queries raised by monitoring activities (average of the total number of queries pointed out in each CRF check) | — |
Countries
Japan
Contacts
Tokyo Medical and Dental University Medical Innovation Promotion Center/Department of Neurology