Vertebral Compression FractureNCT05912504
Long Term Follow-up of Vertebral Compression Fracture In-patients Treated: A Retrospective Chart Review and Survey
An observational study of Vertebral Compression Fracture and Korean Traditional 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 safety of integrative Korean medicine for Vertebral Compression Fracture in-patients 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 80 years
- Conditions the study is for
- Vertebral Compression Fracture, Korean Traditional Medicine, Integrative Korean Medicine
- What is being tested?
- Phoen survey
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2023to 20 Feb 2024
- How long will I take part?
- 2 Years
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Recruit people who meet the selection criteria and conduct a telephone survey.
Who may be able to join
- Patients diagnosed with Acute Compression Fracture' of thoracic or lumbar vertebrae from EMR X-ray or MRI, CT imaging (The temporal criterion for dividing acute and chronic compression fractures was based on 3 months after symptoms began in the case of compression fractures caused by osteoporosis, and acute and chronic were also divided based on 3 months after trauma.)
- Patient hospitalized for more than a week
- Pateints above 19 years old and below 80 years old
- Patients who have agreed to participate the study
Who cannot join
- Where the vertebral fracture is not a vertebral body, but a transverse protrusion, a polar protrusion, etc.
- Other chronic conditions that may interfere with the interpretation of treatment effects or outcomes: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
- If the cause of pain is due to soft tissue disease, not the spine: tumor, fibromyalgia, rheumatoid arthritis, gout, etc.
- a person with a congenital spinal disorder
- For patients within 3 months of spinal surgery
- A person who is unable to communicate normally due to dementia or mild cognitive impairment;
- Other cases where the researcher is not suitable for participation in the study.
- Those who do not agree to participate in the study.
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 Vertebral Compression Fracture In-patients Treated With Integrated Complementary and Alternative Medicine: A Retrospective Chart Review and Survey
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Vertebral Compression Fracture in-patients by observing inpatients treated with integrative Korean medicine.
This study is a retrospective observational study. The subjects for study are patients diagnosed with Vertebral Compression Fracture and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2022.06.30.
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
- Vertebral Compression Fracture, Korean Traditional Medicine, Integrative Korean Medicine, Vertebral Compression
- Being tested
- Phoen survey
- Keywords
- Compression Fracture, Integrated Complementary and Alternative Medicine:
- Medical subject headings
- Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phoen 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: [Time Frame: Finish survey by November 2023]
Secondary outcomes (6)
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. The investigators will conduct an validated Korean NDI questionnaire
Measured: [Time Frame: Finish survey by November 2023]
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: [Time Frame: Finish survey by November 2023]
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: [Time Frame: Finish survey by November 2023]
Spine Operation
Operation status
Measured: [Time Frame: Finish survey by November 2023]
Treatment after discharge survey
Treatment history after discharge
Measured: [Time Frame: Finish survey by November 2023]
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: [Time Frame: Finish survey by November 2023]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Jan 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebral Compression FractureStudies 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
- Cross-sectional
- Enrolment
- 70 participants (actual)
- Target duration
- 2 Years
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
- Investigators
- In-Hyuk Ha, Dr, Study chair, Bucheon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912504
- Sponsor's protocol ID
- JS-CT-2023-01
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sim HA, Jung W, Kim SD, Park H, Lee J, Jo H, Lee Y, Heo I, Seo BK, Shin WC, Cho JH, Lee YJ, Kim D, Ha IH. Long-term follow-up of vertebral compression fractures in inpatients treated with integrative Korean medicine: An observational study. Medicine (Baltimore). 2026 Jan 9;105(2):e46883. doi: 10.1097/MD.0000000000046883.
PubMed 41517687
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Vertebral Compression Fracture In-patients Treated With Integrated Complementary and Alternative Medicine: A Retrospective Chart Review and Survey
- ClinicalTrials.gov ID
- NCT05912504
- Acronym / sponsor ID
- JS-CT-2023-01
- Conditions
- Vertebral Compression Fracture, Korean Traditional Medicine, Integrative Korean Medicine, Vertebral Compression
- Keywords
- Compression Fracture, Integrated Complementary and Alternative Medicine:
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 22 Jun 2023 (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 Vertebral Compression Fracture in-patients by observing inpatients treated with integrative Korean medicine.
This study is a retrospective observational study. The subjects for study are patients diagnosed with Vertebral Compression Fracture and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2022.06.30.
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
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recruit people who meet the selection criteria and conduct a telephone survey.
Key inclusion criteria (4 listed)
- Patients diagnosed with Acute Compression Fracture' of thoracic or lumbar vertebrae from EMR X-ray or MRI, CT imaging (The temporal criterion for dividing acute and chronic compression fractures was based on 3 months after symptoms began in the case of compression fractures caused by osteoporosis, and acute and chronic were also divided based on 3 months after trauma.)
- Patient hospitalized for more than a week
- Pateints above 19 years old and below 80 years old
- Patients who have agreed to participate the study
Key exclusion criteria (8 listed)
- Where the vertebral fracture is not a vertebral body, but a transverse protrusion, a polar protrusion, etc.
- Other chronic conditions that may interfere with the interpretation of treatment effects or outcomes: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
- If the cause of pain is due to soft tissue disease, not the spine: tumor, fibromyalgia, rheumatoid arthritis, gout, etc.
- a person with a congenital spinal disorder
- For patients within 3 months of spinal surgery
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 |
|---|---|---|
| Phoen 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: [Time Frame: Finish survey by November 2023]
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.
6 secondary outcomes
Oswestry Disability Index(ODI)
Time frame: [Time Frame: Finish survey by November 2023]
The five level version of EuroQol-5 Dimension (EQ-5D)
Time frame: [Time Frame: Finish survey by November 2023]
Patient Global Impression of Change (PGIC)
Time frame: [Time Frame: Finish survey by November 2023]
Spine Operation
Time frame: [Time Frame: Finish survey by November 2023]
Treatment after discharge survey
Time frame: [Time Frame: Finish survey by November 2023]
Satisfaction with integrative Korean medicine survey
Time frame: [Time Frame: Finish survey by November 2023]
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 5 Mar 2026.
- Results publication: PubMed 41517687Sim HA, Jung W, Kim SD, Park H, Lee J, Jo H, Lee Y, Heo I, Seo BK, Shin WC, Cho JH, Lee YJ, Kim D, Ha IH. Long-term follow-up of vertebral compression fractures in inpatients treated with integrative Korean medicine: An observational study. Medicine (Baltimore). 2026 Jan 9;105(2):e46883. doi: 10.1097/MD.0000000000046883.
- Individual participant dataSharing planned: No
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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.
In-Hyuk Ha, Dr study chair
Bucheon Jaseng Hospital of Korean Medicine
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 Vertebral Compression Fracture and Korean Traditional 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 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 5 Mar 2026. 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: [Time Frame: Finish survey by November 2023]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912504, which also lists 1 linked publication.
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 5 Mar 2026.