Characteristics and Medical Resource Utilization of Postoperative Patients

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293212
• Other study ID #: JS-CT-2017-03
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: February 2018
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 prognosis and preference for conventional and Korean medicine treatment by previous treatment history in postoperative patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Medical Foundation	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Jaseng Medical Foundation	Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS) of pain	11-point pain scale	Within 7 days after 1st visit
Secondary	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)	Within 7 days after 1st visit
Secondary	Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)	Oswestry Disability Index (ODI)	Within 7 days after 1st visit
Secondary	Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)	Neck Disability Index (NDI)	Within 7 days after 1st visit
Secondary	Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)	Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)	Within 7 days after 1st visit
Secondary	Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)	Shoulder Pain and Disability Index (SPADI)	Within 7 days after 1st visit
Secondary	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	Within 7 days after 1st visit
Secondary	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.	Within 7 days after 1st visit
Secondary	Medical service use	Type(s) of medical service use before and after surgery post-onset	Within 7 days after 1st visit
Secondary	Medical costs	Medical costs from medical service use before and after surgery post-onset	Within 7 days after 1st visit
Secondary	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	Within 7 days after 1st visit