Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.

July 22, 2022 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.

Study Type

Observational

Enrollment (Actual)

378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.

Description

Inclusion Criteria:

  • Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
  • Patients undergone MRI readings of central spinal stenosis
  • Patients have no communication problems
  • Patients have agreed to participate the study.

Exclusion Criteria:

  • Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
  • Patient hospitalized for pain caused by a traffic accident
  • Patients with serious mental illness
  • Patients deemed unable to participate in the clinical research by other researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale (NRS)
Time Frame: Finish survey by August 2020
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.
Finish survey by August 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index (ODI)
Time Frame: Finish survey by August 2020
he ODI is a 10-item questionnaire developed to evaluate the degree of disability for low 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 ODI questionnaire
Finish survey by August 2020
The five level version of EuroQol-5 Dimension (EQ-5D)
Time Frame: Finish survey by August 2020
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
Finish survey by August 2020
Patient Global Impression of Change (PGIC)
Time Frame: Finish survey by August 2020
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).
Finish survey by August 2020
Spine surgery
Time Frame: Finish survey by August 2020
The number of spinal surgery after discharge
Finish survey by August 2020
Current symptoms
Time Frame: Finish survey by August 2020
Possible walking time without pain, neurological claudication
Finish survey by August 2020
Treatment after discharge
Time Frame: Finish survey by August 2020
Treatment history in the last month
Finish survey by August 2020
hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine
Time Frame: Finish survey by August 2020
Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.
Finish survey by August 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Medical Foundation

Investigators

  • Study Director: In-Hyuk Ha, Dr., Jaseng Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2020

Primary Completion (ACTUAL)

September 16, 2020

Study Completion (ACTUAL)

September 16, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 21, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2020-06

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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