Clinical trial NCT04655833: Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey
Official title: Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: FBSS
Medicine, Korean Traditional
Keywords: acupuncture therapy
herbal medicine
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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)
2. Patients who have progressive neurological defects or severe synchronic neurological symptoms
3. The cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine
4. 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)
5. Patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization
6. Patient who has visited this medical institution within the last six months.
7. Patients deemed unable to participate in the clinical research by other researchers
8. Patients who haven't agreed to participate the study

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: Finish survey by November 2020
Secondary outcomes:
measure: Oswestry Disability Index(ODI)
timeFrame: Finish survey by November 2020
measure: The five level version of EuroQol-5 Dimension (EQ-5D)
timeFrame: Finish survey by November 2020
measure: Patient Global Impression of Change (PGIC)
timeFrame: Finish survey by November 2020
measure: Spine surgery
timeFrame: Finish survey by November 2020
measure: Current symptoms survey
timeFrame: Finish survey by November 2020
measure: Treatment after discharge survey
timeFrame: Finish survey by November 2020
measure: Satisfaction with integrative Korean medicine survey
timeFrame: Finish survey by November 2020
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
References: