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NCT Number: NCT03293212

Characteristics and Medical Resource Utilization of Postoperative Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Medical Foundation

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Numeric rating scale (NRS) of pain

    Time frame: Within 7 days after 1st visit

    11-point pain scale

Secondary outcomes

  1. Five level version of EuroQol-5 Dimension (EQ-5D-5L)

    Time frame: 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)

    Time frame: Within 7 days after 1st visit

    Oswestry Disability Index (ODI)

  3. Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)

    Time frame: Within 7 days after 1st visit

    Neck Disability Index (NDI)

  4. Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)

    Time frame: 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)

    Time frame: Within 7 days after 1st visit

    Shoulder Pain and Disability Index (SPADI)

  6. Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)

    Time frame: 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)

    Time frame: 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

    Time frame: Within 7 days after 1st visit

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

  9. Medical costs

    Time frame: 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

    Time frame: Within 7 days after 1st visit

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

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Collaborators

  • Korea Institute of Oriental Medicine

Registry information

Official study title

Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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