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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752838
• Other study ID #: JS-CT-2022-14
• Status: Completed
• Start date: November 15, 2022
• Est. completion date: November 16, 2022

Study information

• Verified date: February 2023
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Other:
• No intervention
This is a survey study, and there were no intervention

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Medical Foundation	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survey basic characteristics		1 day
Primary	disease onset survey		1 day
Primary	symptom and its severity survey		1 day
Primary	priority symptoms for improvement survey		1 day
Primary	important factors in treatment survey		1 day