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

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 Acute 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 Acute 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 Overview

• Status: Recruiting
• Conditions: Vertebral Compression Fracture; Vertebral Compression; Korean Traditional Medicine; Integrative Korean Medicine
• Intervention / Treatment: Other: Phoen survey

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: In-Hyuk Ha, Dr; Phone Number: 1577-0007; Email: hanihata@gmail.com
• Study Contact Backup: Name: Hyun A Sim, Dr; Phone Number: 82-10-63406443; Email: sha0404@jaseng.org

Study Locations

• Korea, Republic of
  • Gyeonggi Province
    • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
      • Recruiting
      • Bucheon Jaseng Hospital of Korean Medicine
      • Contact: Yeonsun Lee, KMD, M.Sc.; Phone Number: 01034466314; Email: ewidesun@jaseng.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	[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).	[Time Frame: Finish survey by November 2023]
Spine Operation	Operation status	[Time Frame: Finish survey by November 2023]
Treatment after discharge survey	Treatment history after discharge	[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.	[Time Frame: Finish survey by November 2023]
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	[Time Frame: Finish survey by November 2023]

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Chair: In-Hyuk Ha, Dr, Bucheon Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): August 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Compression Fracture; Integrated Complementary and Alternative Medicine:
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• Other Study ID Numbers: JS-CT-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No