- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293212
Characteristics and Medical Resource Utilization of Postoperative Patients
Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of
- Jaseng Medical Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
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) of pain
Time Frame: Within 7 days after 1st visit
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11-point pain scale
|
Within 7 days after 1st visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Within 7 days after 1st visit
|
|
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)
|
Within 7 days after 1st visit
|
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Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
Time Frame: Within 7 days after 1st visit
|
Neck Disability Index (NDI)
|
Within 7 days after 1st visit
|
|
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)
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Within 7 days after 1st visit
|
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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)
|
Within 7 days after 1st visit
|
|
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
|
Within 7 days after 1st visit
|
|
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.
|
Within 7 days after 1st visit
|
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Medical service use
Time Frame: Within 7 days after 1st visit
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Type(s) of medical service use before and after surgery post-onset
|
Within 7 days after 1st visit
|
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Medical costs
Time Frame: Within 7 days after 1st visit
|
Medical costs from medical service use before and after surgery post-onset
|
Within 7 days after 1st visit
|
|
Satisfaction with and preference for conventional and Korean medicine
Time Frame: Within 7 days after 1st visit
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Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale
|
Within 7 days after 1st visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: In-Hyuk Ha, KMD, M.Sc., Jaseng Medical Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2017-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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