Clinical trial NCT05912504: Long Term Follow-up of Vertebral Compression Fracture In-patients Treated: A Retrospective Chart Review and Survey
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Compression Fracture
Korean Traditional Medicine
Integrative Korean Medicine
Vertebral Compression
Keywords: Compression Fracture
Integrated Complementary and Alternative Medicine:
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruit people who meet the selection criteria and conduct a telephone survey.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. 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.)
2. Patient hospitalized for more than a week
3. Pateints above 19 years old and below 80 years old
4. Patients who have agreed to participate the study

Exclusion Criteria:

1. Where the vertebral fracture is not a vertebral body, but a transverse protrusion, a polar protrusion, etc.
2. Other chronic conditions that may interfere with the interpretation of treatment effects or outcomes: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
3. If the cause of pain is due to soft tissue disease, not the spine: tumor, fibromyalgia, rheumatoid arthritis, gout, etc.
4. a person with a congenital spinal disorder
5. For patients within 3 months of spinal surgery
6. A person who is unable to communicate normally due to dementia or mild cognitive impairment;
7. Other cases where the researcher is not suitable for participation in the study.
8. Those who do not agree to participate in the study.

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: [Time Frame: Finish survey by November 2023]
Secondary outcomes:
measure: Oswestry Disability Index(ODI)
timeFrame: [Time Frame: Finish survey by November 2023]
measure: The five level version of EuroQol-5 Dimension (EQ-5D)
timeFrame: [Time Frame: Finish survey by November 2023]
measure: Patient Global Impression of Change (PGIC)
timeFrame: [Time Frame: Finish survey by November 2023]
measure: Spine Operation
timeFrame: [Time Frame: Finish survey by November 2023]
measure: Treatment after discharge survey
timeFrame: [Time Frame: Finish survey by November 2023]
measure: Satisfaction with integrative Korean medicine survey
timeFrame: [Time Frame: Finish survey by November 2023]
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
Study officials:
affiliation: Bucheon Jaseng Hospital of Korean Medicine
name: In-Hyuk Ha, Dr
role: STUDY_CHAIR
References: