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

Long Term Follow up of Failed Back Surgery Syndrome(FBSS) Patients With Korean Integrative Medicine Treatment: 10-year Follow-up Prospective Study With Survey

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.

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome; Integrative Medicine; Medicine, Korean Traditional
• Intervention / Treatment: Other: phone survey

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi Province
    • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
      • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Spine surgery	The number of spinal surgery after treatment	Finish survey by June 2021
Latest treatment	Latest treatment history about Failed Back Surgery Syndrome	Finish survey by June 2021
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
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
Return to daily life	How helpful treatment has been for returning to work and adjusting to daily life.	Finish survey by June 2021

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: integrative Korean medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: JS-CT-2021-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No