Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey
- Conditions
- Medicine, Korean TraditionalFBSS
- Registration Number
- NCT04655833
- Lead Sponsor
- Jaseng Medical Foundation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Numeric rating scale (NRS) 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 Outcome Measures
Name Time Method Satisfaction with integrative Korean medicine survey 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.
Current symptoms survey Finish survey by November 2020 Pain, neurological problems, etc.
The five level version of EuroQol-5 Dimension (EQ-5D) 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.
Oswestry Disability Index(ODI) 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
Patient Global Impression of Change (PGIC) 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).
Spine surgery Finish survey by November 2020 The number of spinal surgery after discharge
Treatment after discharge survey Finish survey by November 2020 Treatment history in the last 3 month
Trial Locations
- Locations (1)
Jaseng Medical Foundation
🇰🇷Seoul, Korea, Republic of