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Completed

NCT Number: NCT04443738

Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.

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Key information

Conditions

Spinal Stenosis Lumbar Medicine, Korean Traditional

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Seoul, South Korea

About this study

This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
  • Patients undergone MRI readings of central spinal stenosis
  • Patients have no communication problems
  • Patients have agreed to participate the study.

Exclusion criteria

  • Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
  • Patient hospitalized for pain caused by a traffic accident
  • Patients with serious mental illness
  • Patients deemed unable to participate in the clinical research by other researchers

Treatment and study plan

phone survey

Other

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

Primary outcomes

  1. Numeric rating scale (NRS)

    Time frame: Finish survey by August 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 August 2020

    he ODI is a 10-item questionnaire developed to evaluate the degree of disability for low 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 ODI questionnaire

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

    Time frame: Finish survey by August 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 August 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 August 2020

    The number of spinal surgery after discharge

  5. Current symptoms

    Time frame: Finish survey by August 2020

    Possible walking time without pain, neurological claudication

  6. Treatment after discharge

    Time frame: Finish survey by August 2020

    Treatment history in the last month

  7. hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine

    Time frame: Finish survey by August 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
Jun 23, 2020
Registry last updated
Jul 26, 2022

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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