Clinical trial NCT03293212: Characteristics and Medical Resource Utilization of Postoperative Patients
Official title: Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Postoperative pain
Failed back surgery syndrome
Korean medicine
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2017-09-26
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly visiting 4 sites of Jaseng Hospital of Korean Medicine due to postoperative pain

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Numeric rating scale (NRS) of pain
timeFrame: Within 7 days after 1st visit
Secondary outcomes:
measure: Five level version of EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: Within 7 days after 1st visit
measure: Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)
timeFrame: Within 7 days after 1st visit
measure: Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
timeFrame: Within 7 days after 1st visit
measure: Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)
timeFrame: Within 7 days after 1st visit
measure: Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)
timeFrame: Within 7 days after 1st visit
measure: Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
timeFrame: Within 7 days after 1st visit
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Within 7 days after 1st visit
measure: Medical service use
timeFrame: Within 7 days after 1st visit
measure: Medical costs
timeFrame: Within 7 days after 1st visit
measure: Satisfaction with and preference for conventional and Korean medicine
timeFrame: Within 7 days after 1st visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: