Efficacy and Safety of Chuna Manual Treatment as an Adjunctive Therapy After Total Knee Arthroplasty: A Study Protocol for a Single-Center, Randomized, Assessor Blind, Parallel-Group Clinical Trial
NCT ID: NCT03625050
Last Updated: 2021-07-08
Study Results
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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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2018-11-01
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chuna + Usual care
Chuna + Usual care(Celecoxib and esomeprazole)
Chuna therapy (CT), 2 sessions/week, 4 weeks (8 sessions in total) Usual care therapy (UC, Celecoxib 200mg, qd and esomeprazole 20mg, qd), 4 weeks
Usual care consists of physical therapy, CP based medications and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
CT and UC group will receive the same UC regimen.
Usual care
Usual care(Celecoxib and esomeprazole)
Usual care therapy (UC, Celecoxib 200mg, qd and esomeprazole 20mg, qd), 4 weeks
Usual care consists of physical therapy, CP based medications and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
Interventions
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Chuna + Usual care(Celecoxib and esomeprazole)
Chuna therapy (CT), 2 sessions/week, 4 weeks (8 sessions in total) Usual care therapy (UC, Celecoxib 200mg, qd and esomeprazole 20mg, qd), 4 weeks
Usual care consists of physical therapy, CP based medications and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
CT and UC group will receive the same UC regimen.
Usual care(Celecoxib and esomeprazole)
Usual care therapy (UC, Celecoxib 200mg, qd and esomeprazole 20mg, qd), 4 weeks
Usual care consists of physical therapy, CP based medications and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
Eligibility Criteria
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Inclusion Criteria
* Patients who have agreed to trial participation and provided written informed consent
Exclusion Criteria
* Those taking analgesics for the purpose of relieving pain, fever and inflammation within 7 days
* Those with progressive neurological deficits or with severe neurological symptoms
* Those who have other chronic conditions that may interfere with the interpretation of treatment effects or outcomes : Cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Those who are not fit or unsafe to chuna therapy: clotting disorders, Those receiving anticoagulant therapy, Severe diabetes patients who are at risk of infection, severe cardiovascular disease
* 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.
60 Years
ALL
No
Sponsors
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Catholic Kwandong University
OTHER
Gachon University Gil Oriental Medical Hospital
OTHER
Responsible Party
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Yun-Kyung Song
Sponsor-principle 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 Hospita
Incheon, , South Korea
Countries
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Other Identifiers
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ISEE_2018_TKA_CN
Identifier Type: -
Identifier Source: org_study_id
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