Long Term Follow up of Failed Back Surgery Syndrome(FBSS)

Sponsor

Jaseng Medical Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT04905927

Collaborator

(none)

106

Enrollment

Location

5.2

Actual Duration (Months)

20.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome Integrative Medicine Medicine, Korean Traditional	Other: phone survey

Study Design

Study Type:

Observational

Actual Enrollment :

106 participants

Observational Model:

Other

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 14, 2021

Actual Primary Completion Date :

Nov 18, 2021

Actual Study Completion Date :

Nov 18, 2021

Outcome Measures

Primary Outcome Measures

Numeric rating scale (NRS) [Finish survey by June 2021]
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

Oswestry disability index (ODI) [Finish survey by June 2021]
The 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
Korean-Short Form Healthy Survey 36 [Finish survey by June 2021]
Short Form Healthy Survey 36(SF-36) is used as a method of indirectly calculating the Health related quality of life from various aspects. The Short Form Healthy Survey 36(SF-36) consists of 36 questions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health) that ask about the current state of health. In this study, SF-36v2™ Health Survey 1996, 2004 Health Assessment Lab, Medical Outcomes Trust and QualityMetric Incorporated. All rights reserved. SF-36® is a registered trademark of Medical Outcomes Trust. (IQOLA SF-36v2 Standard, Korea (Korean)) will be used
Patient Global Impression of Change (PGIC) [Finish survey by June 2021]
PGIC is an indicator that evaluates the improvement of patients in 5 steps, and the subject responds with improvement of functional limitation after treatment with 5 likert. (1=completely improved, 2=distinctly improved, 3=improved, 4=no significant difference, 5=worsened)
Spine surgery [Finish survey by June 2021]
The number of spinal surgery after treatment
Latest treatment [Finish survey by June 2021]
Latest treatment history about Failed Back Surgery Syndrome
Improvement of patients [Finish survey by June 2021]
5 steps (1=completely improved, 2=distinctly improved, 3=improved, 4=no significant difference, 5=worsened) are used to evaluate the improvement of patients
Patient satisfaction [Finish survey by June 2021]
7 steps (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse) are used to evaluate the satisfaction of patients
Return to daily life [Finish survey by June 2021]
How helpful treatment has been for returning to work and adjusting to daily life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province	Korea, Republic of	14598

Sponsors and Collaborators

Jaseng Medical Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation

ClinicalTrials.gov Identifier:

NCT04905927

Other Study ID Numbers:

JS-CT-2021-03

First Posted:

May 28, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation

integrative Korean medicine

Additional relevant MeSH terms:

Syndrome

Failed Back Surgery Syndrome

Study Results

No Results Posted as of Nov 19, 2021