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

NCT05752838 | Completed

• 1 other identifier: JS-CT-2022-14
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Diagnosed with LDH and had LDH-related radiating leg pain

Other: No intervention

Interventions

No intervention OTHER

This is a survey study, and there were no intervention

Diagnosed with LDH and had LDH-related radiating leg pain

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• severe mental illness and intellectual disabilities that prevented independence in answering the questionnaire

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, Gangnam-gu, 06110, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha, PhD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: November 15, 2022
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)