Clinical trial NCT03633097: 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-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Replacement
Acupuncture
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2018-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change from baseline in Korean version of Western Ontario and McMaster Universities Arthritis Index
timeFrame: Screening, day 11, day 21
Secondary outcomes:
measure: Change from baseline in Numeric rating scale
timeFrame: Screening, baseline, day 5, 11, 21, 28, 84
measure: Change from baseline in Physical Condition related with mobility at every visit
timeFrame: Screening, day 11, day 84
measure: Change from baseline in Physical Condition related with endurance at every visit
timeFrame: Screening, day 11, day 84
measure: Change from baseline in Timed Up and Go Test at every visit
timeFrame: Screening, day 11, day 84
measure: Change from baseline in Alternative-Step Test at every visit
timeFrame: Screening, day 11, day 84
measure: Change from baseline in Range of motion
timeFrame: Screening, baseline, day 5, 11, 28, 84
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary'S Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary'S Hospita
Study officials:
affiliation: Gachon university of Gil oriental hospital
name: Yun Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park TY, Kim HJ, Lee JH, Sunwoo YY, Do KS, Han SN, Song YK, Chae DS. Efficacy and safety of acupuncture treatment as an adjunctive therapy after knee replacement: Single-center, pragmatic, randomized, assessor blinded, pilot study. Medicine (Baltimore). 2021 Mar 12;100(10):e24941. doi: 10.1097/MD.0000000000024941.