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

Acupuncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633097
• Other study ID #: ISEE_2018_TKA_A
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: May 30, 2021

Study information

• Verified date: July 2021
• Source: Gachon University Gil Oriental Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Knee Replacement

Intervention

Other:
• Acupuncture 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

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

Locations

Country	Name	City	State
Korea, Republic of	Catholic Kwandong University International St. Mary'S Hospita	Incheon
Korea, Republic of	Catholic Kwandong University International St. Mary'S Hospital	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Gachon University Gil Oriental Medical Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in Physical Condition related with endurance at every visit	endurance (Sit-to-stand test - STS) (seconds)	Screening, day 11, day 84
Secondary	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
Secondary	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
Secondary	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