Pain, PostoperativeNCT03293212
Characteristics and Medical Resource Utilization of Postoperative Patients
An observational study of Pain, Postoperative, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2017to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients newly visiting 4 sites of Jaseng Hospital of Korean Medicine due to postoperative pain
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative pain, Failed back surgery syndrome, Korean medicine
- Medical subject headings
- Pain, Postoperative, Failed Back Surgery Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) of pain
11-point pain scale
Measured: Within 7 days after 1st visit
Secondary outcomes (10)
Five level version of EuroQol-5 Dimension (EQ-5D-5L)
Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)
Measured: Within 7 days after 1st visit
Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)
Oswestry Disability Index (ODI)
Measured: Within 7 days after 1st visit
Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
Neck Disability Index (NDI)
Measured: Within 7 days after 1st visit
Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Within 7 days after 1st visit
Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)
Shoulder Pain and Disability Index (SPADI)
Measured: Within 7 days after 1st visit
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Questionnaire assessing the effect of health problems on the ability to work and to perform regular activities
Measured: Within 7 days after 1st visit
Beck Depression Inventory-II (BDI-II)
The Korean version of the BDI-II has been validated and consists of 21 multiple choice items for diagnosis of depression.
Measured: Within 7 days after 1st visit
Medical service use
Type(s) of medical service use before and after surgery post-onset
Measured: Within 7 days after 1st visit
Medical costs
Medical costs from medical service use before and after surgery post-onset
Measured: Within 7 days after 1st visit
Satisfaction with and preference for conventional and Korean medicine
Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale
Measured: Within 7 days after 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start29 Jun 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, KMD, M.Sc., Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293212
- Sponsor's protocol ID
- JS-CT-2017-03
- Status last verified
- Feb 2018
- First submitted
- 19 Sep 2017
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
- ClinicalTrials.gov ID
- NCT03293212
- Acronym / sponsor ID
- JS-CT-2017-03
- Conditions
- Pain, Postoperative
- Keywords
- Postoperative pain, Failed back surgery syndrome, Korean medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients newly visiting 4 sites of Jaseng Hospital of Korean Medicine due to postoperative pain
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numeric rating scale (NRS) of pain
Time frame: Within 7 days after 1st visit
11-point pain scale
10 secondary outcomes
Five level version of EuroQol-5 Dimension (EQ-5D-5L)
Time frame: 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
Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
Time frame: 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
Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)
Time frame: Within 7 days after 1st visit
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Time frame: Within 7 days after 1st visit
Beck Depression Inventory-II (BDI-II)
Time frame: Within 7 days after 1st visit
Medical service use
Time frame: Within 7 days after 1st visit
Medical costs
Time frame: Within 7 days after 1st visit
Satisfaction with and preference for conventional and Korean medicine
Time frame: Within 7 days after 1st visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, KMD, M.Sc. principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) of pain (time frame: Within 7 days after 1st visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.