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

NCT ID: NCT03633097

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2021-05-30

Brief Summary

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

Detailed Description

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Conditions

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Knee Replacement Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
single blinded, outcome assessor blinded

Study Groups

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Acupuncture + Usual care

Acupuncture with Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet

Group Type EXPERIMENTAL

Acupuncture and Usual care

Intervention Type OTHER

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

Usual care

Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type DRUG

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

Interventions

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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

Intervention Type OTHER

Usual care

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

Gachon University Gil Oriental Medical Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yun-Kyung Song

Sponsor-principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun Kyung Song, PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon university of Gil oriental hospital

Locations

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Catholic Kwandong University International St. Mary'S Hospital

Incheon, , South Korea

Site Status

Catholic Kwandong University International St. Mary'S Hospita

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 33725856 (View on PubMed)

Other Identifiers

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ISEE_2018_TKA_A

Identifier Type: -

Identifier Source: org_study_id

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