Patients who have been clinically diagnosed with non-specific low back pain or sciatica with a chief symptom of low back pain, and have been experiencing pain for at least 12 weeks will be considered for inclusion. Patients with pain caused by infections, trauma, and visceral diseases will be excluded.
Conditions
Interventions
None listed
Sponsors
The Japanese Society for Spine Surgery and Related Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men or women aged 20 to 85 years 2) Patients who have been experiencing low back pain for at least 12 weeks despite treatment with acetaminophen, NSAIDS (propionate, arylacetic acid, oxicam, and coxib), tramadol, etc.; or patients who have been experiencing low back pain for at least 12 weeks and have not received drugs. 3) Patients with BS-POP(Brief Scale for Psychiatric Problems in Orthopaedic Patients) scores that do not meet the criteria for psychiatric problems, which is 10 points or more for physicians and 15 points or more for patients.
Exclusion criteria
Exclusion criteria: The following are exclusion criteria established for the safety of the study and the reliability of the endpoint evaluation. 1) Patients with complicated hemorrhagic gastrointestinal diseases. 2) Patients with serious cardiac, hepatic, or renal function disorders, or other serious complications. 3) Patients with advanced blood disorders (bleeding tendency, etc.). 4) Patients with dementia or other psychiatric disorders who would be expected to have difficulties with the evaluation. 5) Patients with a history of alcohol or drug dependence. 6) Patients diagnosed with a malignant tumor within the previous 5 years. Other patients considered inappropriate for study participation will be excluded by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost-benefit: Medical fees/Quality-adjusted life year (Unit: Yen/QALY), Cost-effectiveness: Cost of medical services/Scores of various health indicators (Unit: Yen/Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy-related endpoint: Utility for patients - Preference-based measures -> EQ-5D (EuroQol 5 Dimension)(Unit: QALY) Health level of patients - Comprehensive measures -> SF-8 (MOS short-form 8-item health survey)(Unit: Score) - Disease-specific indicators for low back pain -> RDQ (Roland-Morris Disability Questionnaire), JOA-BPEQ (Japanese Orthopaedic Association Back Pain Evaluation Questionnaire), VAS (Visual Analogue Scale)(Unit: Score) Cost-related endpoint Medical fee bill(Unit: Points or Yen), Cost of medical services(Unit: Yen) | — |
Countries
Japan
Contacts
Public ContactHideki Yoshikawa
Osaka UniversityGraduate School of Medicine Department of Orthopedics
Outcome results
None listed