Lumber Spinal Stenosis
Conditions
Interventions
Comparison in the effect and safety of Mirogabalin add-on therapy to NSAIDs and NSAIDs monotherapy for patients with Lumber Spinal Stenosis and administrated of NSAIDs.
1) NSAIDs monotherapy as a stud
Sponsors
Nikaido Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have lower limb pain caused by nerve root-type Lumber Spinal Stenosis and can be judged that more than 3 months have passed since the occurrence of the pain has started. (Refer to "Procedure for diagnosis of nerve root-type Lumber Spinal Stenosis" for details.) 2) Patients who is administrated NSAIDS at the enrollment and have not changed dose for more than 4 weeks before the enrollment. 3) Patients with more 40mm of VAS for lower limb pain at informed consent and the enrollment. 4) Patients with 20 years old or older at the enrollment. 5) Patients who are able to understand the procedure of the clinical study, answer a question appropriately and give their voluntary written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Patients who used prohibited drugs within 7 days before the enrollment of the study. 2) Patients who changed administration and dosage of limited drugs within 4 weeks before the enrollment of the study. 3) Patients who have severe pain caused by symptoms except for Lumber Spinal Stenosis and have difficulty being evaluated for the study. 4) Patients with cauda equina type or mixed-type Lumber Spinal Stenosis. 5) Patients who have past history of lumber spine surgery 6) Patients who have complication of cancer, infectious disease and fracture at the enrollment. 7) Patients who have past history of hypersensitivity to ingredients of Mirogabalin. 8) Patients who have difficulty participating in the study due to severe complication of liver disease, kidney disease and heart disease. 9) Pregnancy patients or patients who have possibility of pregnancy. 10) Patients with creatinine clearance less than 30mL/min by Cockroft-Gault Equation at enrollment 11) Patients with more than 11 points or 10 points in physician version of "the Brief Scale for Psychiatric Problems in Orthopaedic Patients" (BS POP) and also 15 points in patient version of BS POP. 12) Patients who are inappropriate for participation in the study for othe reason in the opinion of the investigator or sub-investigator. 13) Previous treatment with Mirogabalin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale of lower limb pain; Amount of the change of pain intensity(VAS providing a range scores from 0-100: no pain 0mm and the worst severe pain imaginable 100mm)from the enrollment(baseline) to at 12 weeks of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of the changes of QOL scores from responses of the EQ-5D-5L. 2. PGIC | — |
Contacts
Public ContactTakuya Nikaido
Fukushima Medical University Hospital
Outcome results
None listed