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

Not Applicable

Completed

• Conditions: Knee Replacement; Acupuncture
• Interventions: Other: Acupuncture and Usual care; Drug: Usual care

• Registration Number: NCT03633097
• Lead Sponsor: Gachon University Gil Oriental Medical Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Study Start: 2018-11-30
• Primary Completion: 2020-12-30
• Study Completion: 2021-05-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture + Usual care	Acupuncture and Usual care	Acupuncture with Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet
Usual care	Usual care	Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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).
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 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.

Trial Locations

Locations (2)

Catholic Kwandong University International St. Mary'S Hospital; 🇰🇷 Incheon, Korea, Republic of

Catholic Kwandong University International St. Mary'S Hospita; 🇰🇷 Incheon, Korea, Republic of