Socioeconomic evaluation of clinical pharmacology to chronic low back pai

Not Applicable

Recruiting

• Conditions: 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.

• Registration Number: JPRN-UMIN000016669
• Lead Sponsor: The Japanese Society for Spine Surgery and Related Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)