FBSSNCT04655833
Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey
An observational study of FBSS and Medicine, Korean Traditional, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine. This study is a retrospective observational study. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- FBSS, Medicine, Korean Traditional
- What is being tested?
- phone survey
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2020to 24 Dec 2020
- 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
- Adult, Older adult
Study population: The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31
Who may be able to join
- Patient who has a past history of lumbar surgery and has been hospitalized for persistent or recurrent pain and discomfort
- Patient hospitalized for more than a week
- Pateints above 19 years old and below 70 years old
- Patients who have agreed to participate the study
Who cannot join
- Patients who have been diagnosed with certain serious diseases that may cause back pain or limb pain (tumor metastases to the spine, spinal infections, ankylosing spondylitis(AS), acute fractures, spinal dislocation and so on)
- Patients who have progressive neurological defects or severe synchronic neurological symptoms
- The cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine
- Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
- Patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization
- Patient who has visited this medical institution within the last six months.
- Patients deemed unable to participate in the clinical research by other researchers
- Patients who haven't agreed to participate the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine.
This study is a retrospective observational study. The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Oswestry Disability Index(ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.
- Conditions
- FBSS, Medicine, Korean Traditional
- Being tested
- phone survey
- Keywords
- acupuncture therapy, herbal medicine
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 November 2020
Secondary outcomes (7)
Oswestry Disability Index(ODI)
ODI is a 10-item questionnaire developed to evaluate the degree of disability for lower 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 NDI questionnaire
Measured: Finish survey by November 2020
The five level version of EuroQol-5 Dimension (EQ-5D)
EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used.
Measured: Finish survey by November 2020
Patient Global Impression of Change (PGIC)
PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Measured: Finish survey by November 2020
Spine surgery
The number of spinal surgery after discharge
Measured: Finish survey by November 2020
Current symptoms survey
Pain, neurological problems, etc.
Measured: Finish survey by November 2020
Treatment after discharge survey
Treatment history in the last 3 month
Measured: Finish survey by November 2020
Satisfaction with integrative Korean medicine survey
Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.
Measured: Finish survey by November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start22 Oct 2020
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FBSSStudies 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
- Retrospective
- 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
- NCT04655833
- Sponsor's protocol ID
- JS-CT-2020-09-017
- Status last verified
- Jan 2021
- First submitted
- 30 Nov 2020
- Last updated
- 20 Jan 2021
- Results posted
- 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey
- ClinicalTrials.gov ID
- NCT04655833
- Acronym / sponsor ID
- JS-CT-2020-09-017
- Conditions
- FBSS, Medicine, Korean Traditional
- Keywords
- acupuncture therapy, herbal medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 7 Dec 2020 (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 safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine.
This study is a retrospective observational study. The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Oswestry Disability Index(ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31
Key inclusion criteria (4 listed)
- Patient who has a past history of lumbar surgery and has been hospitalized for persistent or recurrent pain and discomfort
- Patient hospitalized for more than a week
- Pateints above 19 years old and below 70 years old
- Patients who have agreed to participate the study
Key exclusion criteria (8 listed)
- Patients who have been diagnosed with certain serious diseases that may cause back pain or limb pain (tumor metastases to the spine, spinal infections, ankylosing spondylitis(AS), acute fractures, spinal dislocation and so on)
- Patients who have progressive neurological defects or severe synchronic neurological symptoms
- The cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine
- Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
- Patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization
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 November 2020
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.
7 secondary outcomes
Oswestry Disability Index(ODI)
Time frame: Finish survey by November 2020
The five level version of EuroQol-5 Dimension (EQ-5D)
Time frame: Finish survey by November 2020
Patient Global Impression of Change (PGIC)
Time frame: Finish survey by November 2020
Spine surgery
Time frame: Finish survey by November 2020
Current symptoms survey
Time frame: Finish survey by November 2020
Treatment after discharge survey
Time frame: Finish survey by November 2020
Satisfaction with integrative Korean medicine survey
Time frame: Finish survey by November 2020
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 20 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for FBSS
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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
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Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
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Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Recruiting
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
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 FBSS and Medicine, Korean Traditional, 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 8 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 20 Jan 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 November 2020). 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 20 Jan 2021.