Long Term Follow-up of Vertebral Compression Fracture In-patients Treated: A Retrospective Chart Review and Survey

NCT05912504 | Completed

• 1 other identifier: JS-CT-2023-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Compression Fracture; Korean Traditional Medicine; Integrative Korean Medicine; Vertebral Compression

Keywords

Compression Fracture; Integrated Complementary and Alternative 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.

  [Time Frame: Finish survey by November 2023]

Secondary Outcomes (6)

• Oswestry Disability Index(ODI)

  [Time Frame: Finish survey by November 2023]

• The five level version of EuroQol-5 Dimension (EQ-5D)

  [Time Frame: Finish survey by November 2023]

• Patient Global Impression of Change (PGIC)

  [Time Frame: Finish survey by November 2023]

• Spine Operation

  [Time Frame: Finish survey by November 2023]

• Treatment after discharge survey

  [Time Frame: Finish survey by November 2023]

Interventions

Phoen 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 - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruit people who meet the selection criteria and conduct a telephone survey.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Related Publications (1)

• 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.

  PMID: 41517687 RESULT

MeSH Terms

Conditions

Fractures, Compression

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• In-Hyuk Ha, Dr

  Bucheon Jaseng Hospital of Korean Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: January 20, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)