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

NCT ID: NCT05752838

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2022-11-16

Brief Summary

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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

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Conditions

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Lumbar Disc Herniation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diagnosed with LDH and had LDH-related radiating leg pain

No intervention

Intervention Type OTHER

This is a survey study, and there were no intervention

Interventions

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No intervention

This is a survey study, and there were no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In-Hyuk Ha, PhD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

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Jaseng Medical Foundation

Seoul, Gangnam-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JS-CT-2022-14

Identifier Type: -

Identifier Source: org_study_id

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