The Effect of Integrated CAM Treatment in Hospitalized Patients

September 26, 2023 updated by: Jaseng Hospital of Korean Medicine

The Effect of Integrated CAM Treatment in Patients Hospitalized at a Korean Medicine Hospital

This study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study investigates the effect of hospital-based intensive non-surgical treatment in musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Inpatients received treatment according to a CAM treatment protocol (herbal medicine, acupuncture, bee venom pharmacopuncture, and Chuna manipulation) and conventional medicine treatment as needed. The main outcome measures were the duration of pain, NRS of back pain, radiating leg pain, neck pain, radiating arm pain, knee pain, shoulder pain, previous surgery, previous interventions (injections), Oswestry Disability Index (ODI), Vernon-Mior Neck Disability Index, the Korean Western Ontario McMaster Index, Shoulder Pain and Disability Index, range of motion (ROM), Straight leg raise test (SLR), alcohol use, smoking at admission, 2 weeks, and discharge.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Me-riong Kim, Master
  • Phone Number: +82 2 2222 2746
  • Email: krmkmr@naver.com

Study Locations

  • Korea, Republic of
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, Korea, Republic of, 06110
        • Recruiting
        • Jaseng Hospital of Korean Medicine
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Musculoskeletal patients admitted to an integrated hospital that offers both complementary and alternative medicine (CAM) and conventional medicine treatment.

Description

Inclusion Criteria:

  • Patients hospitalized due to spine or joint diseases

Exclusion Criteria:

  • Main complaint other than back pain, radiating leg pain, neck pain, radiating arm pain, knee pain or shoulder pain
  • Cause of pain non-related to spine, joint or soft tissue; for example, spinal tumors, pregnancy, urolithiasis, etc.
  • Refusal to provide the information needed for clinical research

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS of low back pain (LBP)
Time Frame: Admission (baseline), 2 weeks, Discharge
The patients were asked to quantify their current LBP, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
Admission (baseline), 2 weeks, Discharge
NRS of radiating leg pain
Time Frame: Admission (baseline), 2 weeks, Discharge
The patients were asked to quantify their current leg pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
Admission (baseline), 2 weeks, Discharge
NRS of neck pain
Time Frame: Admission (baseline), 2 weeks, Discharge
The patients were asked to quantify their current neck pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
Admission (baseline), 2 weeks, Discharge
NRS of radiating arm pain
Time Frame: Admission (baseline), 2 weeks, Discharge
The patients were asked to quantify their current radiating arm pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
Admission (baseline), 2 weeks, Discharge
NRS of knee pain
Time Frame: Admission (baseline), 2 weeks, Discharge
The patients were asked to quantify their current knee pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
Admission (baseline), 2 weeks, Discharge
NRS of shoulder pain
Time Frame: Admission (baseline), 2 weeks, Discharge
The patients were asked to quantify their current shoulder pain, setting no pain as 0 and the most severe pain that they could possibly imagine as 10.
Admission (baseline), 2 weeks, Discharge
Oswestry disability index (ODI)
Time Frame: Admission (baseline), 2 weeks, Discharge
The ODI is a survey assessing the patients' degree of functional disability in daily life consisting of 10 questions with 6 choices each corresponding to 0-5 points. The scores for each item are added, divided by 50, then multiplied by 100 to calculate the degree of disability. The Korean version of the ODI of which the reliability and validity have been verified through the research of Jeon et al. was used in this study.
Admission (baseline), 2 weeks, Discharge
Vernon-Mior Neck Disability Index (NDI)
Time Frame: Admission (baseline), 2 weeks, Discharge
NDI is a survey for evaluating disabilities that can be caused by neck pain in daily life performance. It consists of a total of 50 points by selecting a number from 0 to 5 for each item in 10 questions. The higher the score, the greater the daily disability.
Admission (baseline), 2 weeks, Discharge
The Korean Western Ontario McMaster Index
Time Frame: Admission (baseline), 2 weeks, Discharge

WOMAC is one of the most widely used indicators of the overall joint function score of the knee joint. A tool for evaluating disorders related to osteoarthritis of the lower extremities, including joints or knee joints.

WOMAC consists of a total of 24 questions and three subscales. It consists of 5 questions about pain, 2 questions about stiffness, and 17 questions about difficulty in performing daily life related to the rest of the physical functions, so it is designed to measure the overall functional state of the joint.
Admission (baseline), 2 weeks, Discharge
Shoulder Pain and Disability Index
Time Frame: Admission (baseline), 2 weeks, Discharge
SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Admission (baseline), 2 weeks, Discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical and neurological examinations
Time Frame: Admission (baseline), 2 weeks, Discharge
The range of flexion and extension was assessed to objectively measure mobility, and straight leg raising (SLR), sensory function, muscle strength, and deep tendon reflex tests were conducted for neurological assessment.
Admission (baseline), 2 weeks, Discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other baseline variables
Time Frame: Admission (baseline)
The duration of pain, previous surgery, previous interventions (injections), alcohol use, smoking
Admission (baseline)

Collaborators and Investigators

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

Sponsor

Jaseng Hospital of Korean Medicine

Investigators

  • Principal Investigator: In-Hyuk Ha, PhD, 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)

January 1, 2012

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimated)

October 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2012-03

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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