Clinical trial NCT04905927: Long Term Follow up of Failed Back Surgery Syndrome(FBSS)
Official title: Long Term Follow up of Failed Back Surgery Syndrome(FBSS) Patients With Korean Integrative Medicine Treatment: 10-year Follow-up Prospective Study With Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Back Surgery Syndrome
Integrative Medicine
Medicine, Korean Traditional
Keywords: integrative Korean medicine
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects for study are patients diagnosed with Failed Back Surgery Syndrome and who have been admitted to two Jaseng Hospital of Korean medicine (Gangnam, Bucheon) for 2011.11-2014.09

Brief summary: The purpose of this study is to reveal the effectiveness and satisfaction of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observation patients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with Failed Back Surgery Syndrome(FBSS) and who have been admitted to Gangnam Jaseng Hospital of Korean medicine and Bucheon Jaseng Hospital of Korean medicine for 2011.11-2014.09.

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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Failed Back Surgery Syndrome and was admitted to Jaseng hospital of Korean medicine.
* Patients have agreed to participate the study.
* Patients who had participated "Long-term course of failed back surgery syndrome (FBSS) patients receiving integrative Korean medicine treatment: a 1 year prospective observational multicenter study"
* Patients aged 19-70 years on the date

Exclusion Criteria:

* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: Finish survey by June 2021
Secondary outcomes:
measure: Oswestry disability index (ODI)
timeFrame: Finish survey by June 2021
measure: Korean-Short Form Healthy Survey 36
timeFrame: Finish survey by June 2021
measure: Patient Global Impression of Change (PGIC)
timeFrame: Finish survey by June 2021
measure: Spine surgery
timeFrame: Finish survey by June 2021
measure: Latest treatment
timeFrame: Finish survey by June 2021
measure: Improvement of patients
timeFrame: Finish survey by June 2021
measure: Patient satisfaction
timeFrame: Finish survey by June 2021
measure: Return to daily life
timeFrame: Finish survey by June 2021
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
Study officials:
References: