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

NCT04655833 | Completed

• 1 other identifier: JS-CT-2020-09-017
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

FBSS; Medicine, Korean Traditional

Keywords

acupuncture therapy; herbal medicine

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS)

  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.

  Finish survey by November 2020

Secondary Outcomes (7)

• Oswestry Disability Index(ODI)

  Finish survey by November 2020

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

  Finish survey by November 2020

• Patient Global Impression of Change (PGIC)

  Finish survey by November 2020

• Spine surgery

  Finish survey by November 2020

• Current symptoms survey

  Finish survey by November 2020

Interventions

phone survey OTHER

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

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: October 22, 2020
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)