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

N/ACompletedNCT03633097

Gachon University Gil Oriental Medical Hospital50 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Knee Replacement Acupuncture

Interventions

Acupuncture and Usual careOTHER

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

Usual careDRUG

patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

Catholic Kwandong University International St. Mary'S Hospital

Incheon, South Korea

Catholic Kwandong University International St. Mary'S Hospita

Incheon, South Korea

Outcomes

Primary Outcomes

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

Time frame: Screening, day 11, day 21

Secondary Outcomes

Change from baseline in Numeric rating scale

NRS range was 0-10 with 0 being no pain and 10 the worst pain possible.

Time frame: 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)

Time frame: Screening, day 11, day 84

Change from baseline in Physical Condition related with endurance at every visit

endurance (Sit-to-stand test - STS) (seconds)

Time frame: 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).

Time frame: 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)

Time frame: Screening, day 11, day 84

Change from baseline in Range of motion

Data from ClinicalTrials.gov

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