Failed Back Surgery SyndromeNCT04905927
Long Term Follow up of Failed Back Surgery Syndrome(FBSS)
An observational study of Failed Back Surgery Syndrome and Integrative Medicine, run by Jaseng Medical Foundation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Failed Back Surgery Syndrome, Integrative Medicine, Medicine, Korean Traditional
- What is being tested?
- phone survey
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jun 2021to 18 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
About this study
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
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.
- Being tested
- phone survey
- Keywords
- integrative Korean medicine
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone surveyOther
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Finish survey by June 2021
Secondary outcomes (8)
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
Measured: 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
Measured: 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)
Measured: Finish survey by June 2021
Spine surgery
The number of spinal surgery after treatment
Measured: Finish survey by June 2021
Latest treatment
Latest treatment history about Failed Back Surgery Syndrome
Measured: 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
Measured: 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
Measured: Finish survey by June 2021
Return to daily life
How helpful treatment has been for returning to work and adjusting to daily life.
Measured: Finish survey by June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start14 Jun 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905927
- Sponsor's protocol ID
- JS-CT-2021-03
- Status last verified
- Nov 2021
- First submitted
- 25 May 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04905927
- Acronym / sponsor ID
- JS-CT-2021-03
- Keywords
- integrative Korean medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phone surveyA questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients. | Other | – |
Primary outcome
Numeric rating scale (NRS)
Time frame: 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.
8 secondary outcomes
Oswestry disability index (ODI)
Time frame: Finish survey by June 2021
Korean-Short Form Healthy Survey 36
Time frame: Finish survey by June 2021
Patient Global Impression of Change (PGIC)
Time frame: Finish survey by June 2021
Spine surgery
Time frame: Finish survey by June 2021
Latest treatment
Time frame: Finish survey by June 2021
Improvement of patients
Time frame: Finish survey by June 2021
Patient satisfaction
Time frame: Finish survey by June 2021
Return to daily life
Time frame: Finish survey by June 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
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Failed Back Surgery Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome and Integrative Medicine, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) (time frame: Finish survey by June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.