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

Jaseng Medical Foundation

Status: Completed

Conditions: Lumbar Disc Herniation

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05752838

JS-CT-2022-14

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Diagnosed with LDH and had LDH-related radiating leg pain

Treatment:

Other: No intervention