Long Term Follow-up of Acute Vertebral Compression Fracture In-patients Treated With Integrat ed Complementary and Alternative Medicine: A Retrospective Chart Review and Survey

Sponsor
Jaseng Medical Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05912504
Collaborator
(none)
70
1
11
6.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Phoen survey

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Long Term Follow-up of Acute Vertebral Compression Fracture In-patients Treated With Integrat ed Complementary and Alternative Medicine: A Retrospective Chart Review and Survey
Actual Study Start Date :
Jan 20, 2023
Anticipated Primary Completion Date :
Aug 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Outcome Measures

Primary Outcome Measures

  1. Numeric rating scale (NRS) [[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.

Secondary Outcome Measures

  1. Oswestry Disability Index(ODI) [[Time Frame: Finish survey by November 2023]]

    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. We will conduct an validated Korean NDI questionnaire

  2. The five level version of EuroQol-5 Dimension (EQ-5D) [[Time Frame: Finish survey by November 2023]]

    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.

  3. Patient Global Impression of Change (PGIC) [[Time Frame: Finish survey by November 2023]]

    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).

  4. Spine Operation [[Time Frame: Finish survey by November 2023]]

    Operation status

  5. Treatment after discharge survey [[Time Frame: Finish survey by November 2023]]

    Treatment history after discharge

  6. Satisfaction with integrative Korean medicine survey [[Time Frame: Finish survey by November 2023]]

    Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 80 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bucheon Jaseng Hospital of Korean Medicine Bucheon Gyeonggi Province Korea, Republic of 14598

Sponsors and Collaborators

  • Jaseng Medical Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier:
NCT05912504
Other Study ID Numbers:
  • JS-CT-2023-01-006
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023