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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06110
      • Jaseng Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All 19-69 patients who were diagnosed with LDH and had LDH-related radiating leg in Korea

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnosed with LDH and had LDH-related radiating leg pain	Other: No intervention; This is a survey study, and there were no intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: JS-CT-2022-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No