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

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Other: No intervention

• Registration Number: NCT05752838
• Lead Sponsor: Jaseng Medical Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Primary Completion: 2022-11-16
• Study Completion: 2022-11-16
• Status Verified: 2023-02
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• diagnosed of LDH
• age 19-69 years
• presence of LDH-related symptoms such as pain, numbness, weakness, or tingling in the legs
• agree to informed consent form

Exclusion Criteria

• severe mental illness and intellectual disabilities that prevented independence in answering the questionnaire

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnosed with LDH and had LDH-related radiating leg pain	No intervention	-

Primary Outcome Measures

Name	Time	Method
survey basic characteristics	1 day
symptom and its severity survey	1 day
disease onset survey	1 day
priority symptoms for improvement survey	1 day
important factors in treatment survey	1 day

Trial Locations

Locations (1)

Jaseng Medical Foundation; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of