Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement

Official Title
-----------------
Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement - Single-center, Pragmatic, Randomized, Assessor Blinded, Pilot Study-

Conditions
-----------------
Knee Replacement, Acupuncture

Intervention / Treatment
-----------------
* Other: Acupuncture and Usual care
* Drug: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a diagnosis of osteoarthritis and listed for an unilateral total knee replacement. Subject has a normal cognitive function Subject is willing and able to give informed consent for participation in the study. Exclusion Criteria: Those who have undergone total knee arthroplasty due to gout Those who have had total knee arthroplasty due to trauma Those who have had total knee arthroplasty due to autoimmune related diseases such as rheumatoid arthritis Those who are participating in other clinical trials Those who have a history of participating in other clinical trials within one month Those who are difficult to write a research consent form Those who are judged to be inappropriate for the clinical study by the researchers.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture + Usual care<br>Acupuncture with Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet | Other: Acupuncture and Usual care<br>* patients after surgery receive usual care(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet) as well as acupuncture treatment as an adjunctive therapy<br>|
| Active Comparator: Usual care<br>Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet | Drug: Usual care<br>* patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Korean version of Western Ontario and McMaster Universities Arthritis Index | K-WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales | Screening, day 11, day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Numeric rating scale | NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. | Screening, baseline, day 5, 11, 21, 28, 84 | 
| Change from baseline in Physical Condition related with mobility at every visit | mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second) | Screening, day 11, day 84 | 
| Change from baseline in Physical Condition related with endurance at every visit | endurance (Sit-to-stand test - STS) (seconds) | Screening, day 11, day 84 | 
| Change from baseline in Timed Up and Go Test at every visit | a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds). | Screening, day 11, day 84 | 
| Change from baseline in Alternative-Step Test at every visit | a functional test measuring clinical balance performance, and it has been shown to predict fall risk among elderly subjects (seconds) | Screening, day 11, day 84 | 
| Change from baseline in Range of motion | Compare flexion and extension angle using long arm goniometer between experimental and comparator group | Screening, baseline, day 5, 11, 28, 84 |