NCT05752838

A Questionnaire Survey Study for Exploring Outcomes for Patients With Disc Herniation

Are Primary Outcomes Really Primary? A Questionnaire Survey Study for Exploring Outcomes for Patients With Disc Herniation Reflecting Real Patient Symptoms and Needs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

Background: The selection of primary outcomes that reflect the real symptoms and conditions of patients is instrumental in clinical studies on the effectiveness of specific treatment modalities. This study aimed to explore the appropriate outcomes that reflect the real-world needs and concerns of patients with lumbar disc herniation (LDH) and provide a basis for designing related clinical trials. Methods and Findings: This cross-sectional nationwide web-based survey study was conducted in South Korea in November 2022. Patients who were diagnosed with LDH and had LDH-related radiating leg pain were enrolled. The questionnaire consisted of 5 parts: basic characteristics, disease onset, symptom and severity, priority symptoms for improvement, and important factors in treatment. Overall, 500 patients (100 patients from the each age group) were enrolled.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
OTHER	No intervention	This is a survey study, and there were no intervention

Timeline

• Start date: 2022-11-15
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2023-03-03
• Last updated: 2023-03-03

Locations

1 site across 1 country: South Korea