Characteristics and Medical Resource Utilization of Postoperative Patients

NCT03293212 | Completed

• 1 other identifier: JS-CT-2017-03
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Postoperative pain; Failed back surgery syndrome; Korean medicine

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) of pain

  11-point pain scale

  Within 7 days after 1st visit

Secondary Outcomes (10)

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

  Within 7 days after 1st visit

• Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)

  Within 7 days after 1st visit

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

  Within 7 days after 1st visit

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

  Within 7 days after 1st visit

• Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)

  Within 7 days after 1st visit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly visiting 4 sites of Jaseng Hospital of Korean Medicine due to postoperative pain

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jaseng Medical Foundation: lead
• Korea Institute of Oriental Medicine: collaborator

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative; Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Back Pain

Study Officials

• In-Hyuk Ha, KMD, M.Sc.

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 26, 2017
• Study Start: June 29, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: March 29, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)