Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.
- Conditions
- Spinal Stenosis LumbarMedicine, Korean Traditional
- Registration Number
- NCT04443738
- Lead Sponsor
- Jaseng Medical Foundation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 378
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Numeric rating scale (NRS) 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 Outcome Measures
Name Time Method Spine surgery Finish survey by August 2020 The number of spinal surgery after discharge
Oswestry disability index (ODI) 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
The five level version of EuroQol-5 Dimension (EQ-5D) 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
Patient Global Impression of Change (PGIC) 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).
Current symptoms Finish survey by August 2020 Possible walking time without pain, neurological claudication
Treatment after discharge Finish survey by August 2020 Treatment history in the last month
hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine 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.
Trial Locations
- Locations (1)
Jaseng Medical Foundation
🇰🇷Seoul, Korea, Republic of