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

Vertebral Compression Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912504
• Other study ID #: JS-CT-2023-01
• Status: Recruiting
• Start date: January 20, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: March 2024
• Source: Jaseng Medical Foundation
• Contact: In-Hyuk Ha, Dr
• Phone: 1577-0007
• Email: hanihata[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 20, 2024
• Est. primary completion date: August 20, 2024
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Vertebral Compression
• Vertebral Compression Fracture

Intervention

Other:
• Phoen survey
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi Province

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	Spine Operation	Operation status	[Time Frame: Finish survey by November 2023]
Secondary	Treatment after discharge survey	Treatment history after discharge	[Time Frame: Finish survey by November 2023]
Secondary	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]