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

NCT04905927 | Completed

• 1 other identifier: JS-CT-2021-03
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

integrative Korean 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 June 2021

Secondary Outcomes (8)

• Oswestry disability index (ODI)

  Finish survey by June 2021

• Korean-Short Form Healthy Survey 36

  Finish survey by June 2021

• Patient Global Impression of Change (PGIC)

  Finish survey by June 2021

• Spine surgery

  Finish survey by June 2021

• Latest treatment

  Finish survey by June 2021

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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: June 14, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)