Characteristics and Medical Resource Utilization of Postoperative Patients

Sponsor
Jaseng Medical Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT03293212
Collaborator
Korea Institute of Oriental Medicine (Other)
102
1
4.1
25

Study Details

Study Description

Brief Summary

The objective of this study is to assess and analyze the characteristics and usage of conventional and Korean medical services in postoperative patients. This study therefore investigates the proportion of patients with a history of surgery out of patients visiting a spine-specialty Korean medicine hospital, and the prognosis and preference for conventional and Korean medicine treatment by previous treatment history in postoperative patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A considerable number of patients suffer prolonged chronic pain that does not retract or diminish after surgery, and are thus unable to achieve the desired results in receiving surgical treatment. Postoperative pain is gradually being perceived as a social issue as opposed to a personal health condition. Meanwhile, although efforts to address chronic pain with integrative medicine are continued in answer to the lack of success of pain management through surgery, there is still a lack of supporting evidence.

    The objective of this survey study is to assess the characteristics, usage of conventional and Korean medical services, and prognosis by period before and after surgery in postoperative patients visiting a Korean medicine hospital, and analyze the associations between the preference for conventional and Korean medicine treatment. This study therefore investigates the usage of conventional and Korean medical services in postoperative patients, and is expected to provide information that will potentially aid patient decision making.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    102 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
    Actual Study Start Date :
    Jun 29, 2017
    Actual Primary Completion Date :
    Oct 31, 2017
    Actual Study Completion Date :
    Oct 31, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Numeric rating scale (NRS) of pain [Within 7 days after 1st visit]

      11-point pain scale

    Secondary Outcome Measures

    1. Five level version of EuroQol-5 Dimension (EQ-5D-5L) [Within 7 days after 1st visit]

      Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)

    2. Functional disability questionnaire (for low back pain patients as indicated by postoperative condition) [Within 7 days after 1st visit]

      Oswestry Disability Index (ODI)

    3. Functional disability questionnaire (for neck pain patients as indicated by postoperative condition) [Within 7 days after 1st visit]

      Neck Disability Index (NDI)

    4. Functional disability questionnaire (for knee pain patients as indicated by postoperative condition) [Within 7 days after 1st visit]

      Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

    5. Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition) [Within 7 days after 1st visit]

      Shoulder Pain and Disability Index (SPADI)

    6. Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) [Within 7 days after 1st visit]

      Questionnaire assessing the effect of health problems on the ability to work and to perform regular activities

    7. Beck Depression Inventory-II (BDI-II) [Within 7 days after 1st visit]

      The Korean version of the BDI-II has been validated and consists of 21 multiple choice items for diagnosis of depression.

    8. Medical service use [Within 7 days after 1st visit]

      Type(s) of medical service use before and after surgery post-onset

    9. Medical costs [Within 7 days after 1st visit]

      Medical costs from medical service use before and after surgery post-onset

    10. Satisfaction with and preference for conventional and Korean medicine [Within 7 days after 1st visit]

      Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with chief complaint(s) of at least one or more of the following: low back pain (or radiating leg pain), neck pain (or radiating arm pain), knee pain, or shoulder pain

    • Patients with a history of musculoskeletal surgery related to the chief complaint(s)

    • Patients capable of effective communication with the researcher(s) and understanding the survey items

    • Patients who have given written informed consent

    Exclusion Criteria:
    • Patients without a history of musculoskeletal surgery associated with the low back, neck, shoulder, or knee region(s)

    • Patients whose current pain is mainly attributed to traffic accident injury

    • Patients incapable of answering the researcher interviews and surveys

    • Patients with other reasons rendering study participation inappropriate as judged by the researcher(s)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jaseng Medical Foundation Seoul Korea, Republic of

    Sponsors and Collaborators

    • Jaseng Medical Foundation
    • Korea Institute of Oriental Medicine

    Investigators

    • Principal Investigator: In-Hyuk Ha, KMD, M.Sc., Jaseng Medical Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
    ClinicalTrials.gov Identifier:
    NCT03293212
    Other Study ID Numbers:
    • JS-CT-2017-03
    First Posted:
    Sep 26, 2017
    Last Update Posted:
    Mar 29, 2019
    Last Verified:
    Feb 1, 2018
    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 Mar 29, 2019