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

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

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

Study Overview

• Status: Completed
• Conditions: Knee Replacement; Acupuncture
• Intervention / Treatment: Other: Acupuncture and Usual care; Drug: Usual care

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22711
    • Catholic Kwandong University International St. Mary's Hospital
  • Incheon, Korea, Republic of, 22761
    • Catholic Kwandong University International St. Mary'S Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture + Usual care; Acupuncture with Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet	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
Active Comparator: Usual care; Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet	Drug: Usual care; patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change from baseline in Physical Condition related with endurance at every visit	endurance (Sit-to-stand test - STS) (seconds)	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).	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)	Screening, day 11, day 84
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

Collaborators and Investigators

• Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: Korea Health Industry Development Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ISEE_2018_TKA_A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No