The Safety of Pharmacopuncture on Musculoskeletal Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of pharmacopuncture by observing any adverse events that may occur after pharmacopuncture treatment in with spinal joint disease hospitalized patients at 7 Korean medicine hospitals and analyzing blood test results.

Detailed Description
-----------------
This study was an registry observational study, and was conducted in 7 Korean medicine hospitals (160 patients at Jaseng Korean medicine Hospital, 140 patients at Daejeon Jaseng Hospital of Korean Medicine, 140 patients at Bucheon Jaseng Hospital of Korean Medicine, 140 patients at Haeundae Jaseng Korean medicine Hospital, 140 patients at Kyunghee University of Korean medicine Hospital, 140 patients at Kyung Hee University of Korean Medicine Hospital at Gangdong, and 140 patients at Dongguk University Bundang Oriental Hospital).

Official Title
-----------------
The Safety Assessment of Pharmacopuncture on Musculoskeletal Patients: a Multi-center, Registry

Conditions
-----------------
Musculoskeletal Diseases or Conditions, Spine; Arthrosis

Intervention / Treatment
-----------------
* Other: Pharmacopuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients with diagnosed spinal joint disease Patients who received pharmacopuncture treatment during hospitalization Patients who are 19 years of age or older and less than 70 years old Patients who agreed to participate in the clinical study and voluntarily given written informed consent Exclusion Criteria: Patients with difficulty or refusal to give sign written informed consent Patients for whom the researchers judge participation in the clinical study to be difficult

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pharmacopuncture|Registry (observational study)|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection cases | Infection is one of the representative adverse events for subcutaneous and intramuscular interventions. Infection cases will be collected to evaluate the safety of pharmacopuncture. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events refers to undesirable and unintended signs (eg, abnormalities in laboratory test values), symptoms, or diseases that appear after a procedure in the course of a clinical study. Any reported adverse events will be collected to evaluate the safety of pharmacopuncture. | during admission (from day 2 to until discharge), 1 month | 
| Number of abnormal cases that appeared on the blood analysis | Any blood analysis result including liver function and renal function will be measured at admission day and discharge moment. The researcher records every abnormal result cases that appeared on the blood analysis and number of abnormal cases will be counted, to evaluate the safety of pharmacopuncture. | Day 2, discharge day, 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal joint, Safety, Pharmacopuncture, Adverse Event