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

Failed Back Surgery Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905927
• Other study ID #: JS-CT-2021-03
• Status: Completed
• Start date: June 14, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: November 2021
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Integrative Medicine
• Medicine, Korean Traditional
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 June 2021
Secondary	Oswestry disability index (ODI)	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	Finish survey by June 2021
Secondary	Korean-Short Form Healthy Survey 36	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	Finish survey by June 2021
Secondary	Patient Global Impression of Change (PGIC)	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)	Finish survey by June 2021
Secondary	Spine surgery	The number of spinal surgery after treatment	Finish survey by June 2021
Secondary	Latest treatment	Latest treatment history about Failed Back Surgery Syndrome	Finish survey by June 2021
Secondary	Improvement of patients	5 steps (1=completely improved, 2=distinctly improved, 3=improved, 4=no significant difference, 5=worsened) are used to evaluate the improvement of patients	Finish survey by June 2021
Secondary	Patient satisfaction	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	Finish survey by June 2021
Secondary	Return to daily life	How helpful treatment has been for returning to work and adjusting to daily life.	Finish survey by June 2021