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Completed

NCT Number: NCT04655833

Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine.

This study is a retrospective observational study. The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Oswestry Disability Index(ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.

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Key information

Conditions

FBSS Medicine, Korean Traditional

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Seoul, South Korea

Who can participate

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

Inclusion criteria

  • Patient who has a past history of lumbar surgery and has been hospitalized for persistent or recurrent pain and discomfort
  • Patient hospitalized for more than a week
  • Pateints above 19 years old and below 70 years old
  • Patients who have agreed to participate the study

Exclusion criteria

  • Patients who have been diagnosed with certain serious diseases that may cause back pain or limb pain (tumor metastases to the spine, spinal infections, ankylosing spondylitis(AS), acute fractures, spinal dislocation and so on)
  • Patients who have progressive neurological defects or severe synchronic neurological symptoms
  • The cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine
  • Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
  • Patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization
  • Patient who has visited this medical institution within the last six months.
  • Patients deemed unable to participate in the clinical research by other researchers
  • Patients who haven't agreed to participate the study

Treatment and study plan

phone survey

Other

A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.

Primary outcomes

  1. Numeric rating scale (NRS)

    Time frame: Finish survey by November 2020

    NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.

Secondary outcomes

  1. Oswestry Disability Index(ODI)

    Time frame: Finish survey by November 2020

    ODI is a 10-item questionnaire developed to evaluate the degree of disability for lower back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean NDI questionnaire

  2. The five level version of EuroQol-5 Dimension (EQ-5D)

    Time frame: Finish survey by November 2020

    EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used.

  3. Patient Global Impression of Change (PGIC)

    Time frame: Finish survey by November 2020

    PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).

  4. Spine surgery

    Time frame: Finish survey by November 2020

    The number of spinal surgery after discharge

  5. Current symptoms survey

    Time frame: Finish survey by November 2020

    Pain, neurological problems, etc.

  6. Treatment after discharge survey

    Time frame: Finish survey by November 2020

    Treatment history in the last 3 month

  7. Satisfaction with integrative Korean medicine survey

    Time frame: Finish survey by November 2020

    Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2020
Registry last updated
Jan 20, 2021

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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