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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03625050
Other study ID # ISEE_2018_TKA_CN
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 1, 2018
Est. completion date May 31, 2021

Study information

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

Clinical Trial Summary

Evaluate the efficacy and safety of Chuna treatment as an adjunctive therapy in patients with moderate pain following total knee replacement.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 31, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Patients with NRS of knee pain =4 during the 7 days after 3 months total knee replacement - Patients who have agreed to trial participation and provided written informed consent Exclusion Criteria: - Those who have been diagnosed with certain serious diseases that can cause knee pain. : tumor, infectious or inflammatory disease, etc. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
Drug:
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).

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Gachon University Gil Oriental Medical Hospital Catholic Kwandong University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline K-WOMAC score at week 4 Assess the recovery of knee function Week 0, Week 4
Secondary Change from baseline K-WOMAC score at every visit Assess the recovery of knee function Week 0, Week 2, Week 4, Week 8
Secondary Change from baseline EQ-5D score at every visit EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem). Week 0, Week 2, Week 4, Week 8
Secondary Change from baseline Numeric rating scale score at every visit In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'. Week 0, Week 2, Week 4, Week 8
Secondary Change from baseline in Physical Condition related with mobility at every visit mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second) Week 0, Week 2, Week 4, Week 8, Week 12
Secondary Change from baseline in Physical Condition related with endurance at every visit endurance (Sit-to-stand test - STS) (seconds) Week 0, Week 2, Week 4, Week 8, Week 12
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). Week 0, Week 2, Week 4, Week 8, Week 12
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) Week 0, Week 2, Week 4, Week 8, Week 12
Secondary Change from baseline in Range of motion score at every visit Compare flexion and extension angle using long arm goniometer between experimental and comparator group Week 0, Week 2, Week 4, Week 8
Secondary Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively EQ-VAS uses a vertical 10cm line labeled at each end with scale anchors. EQ-VAS is used to indicate the patient's health state and patients are asked to mark a point that represents their health state between the anchors of 'worst health state' and 'best health state imaginable'. Scores are recorded in millimeters with a total range of 0-100 millimeters. Week 0, Week 2, Week 4, Week 8
Secondary Cost per QALY(Quality Adjusted Life Years) gained The quality of life estimation for QALY calculation will use the quality of life derived from EQ-5D as the main evaluation variable, and the calculation method is using Area under the curve method Week 0, Week 4, Week 8, Week 12
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