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Completed

NCT Number: NCT05752838

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Seoul, Gangnam-gu, 06110, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is a survey study, and there were no intervention

Primary outcomes

  1. survey basic characteristics

    Time frame: 1 day

  2. disease onset survey

    Time frame: 1 day

  3. symptom and its severity survey

    Time frame: 1 day

  4. priority symptoms for improvement survey

    Time frame: 1 day

  5. important factors in treatment survey

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2023
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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