Acupuncture, Knee Replacement
Conditions
Brief summary
Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement
Interventions
OTHERAcupuncture and Usual care
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
DRUGUsual care
patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)
Sponsors
Korea Health Industry Development Institute
Gachon University Gil Oriental Medical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single blinded, outcome assessor blinded
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Korean version of Western Ontario and McMaster Universities Arthritis Index | Screening, day 11, day 21 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Physical Condition related with mobility at every visit | Screening, day 11, day 84 | mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second) |
| Change from baseline in Physical Condition related with endurance at every visit | Screening, day 11, day 84 | endurance (Sit-to-stand test - STS) (seconds) |
| Change from baseline in Numeric rating scale | Screening, baseline, day 5, 11, 21, 28, 84 | NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. |
| Change from baseline in Alternative-Step Test at every visit | Screening, day 11, day 84 | a functional test measuring clinical balance performance, and it has been shown to predict fall risk among elderly subjects (seconds) |
| Change from baseline in Range of motion | Screening, baseline, day 5, 11, 28, 84 | Compare flexion and extension angle using long arm goniometer between experimental and comparator group |
| Change from baseline in Timed Up and Go Test at every visit | Screening, day 11, day 84 | 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). |
Countries
South Korea
Outcome results
None listed