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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05752838
Other study ID # JS-CT-2022-14
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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