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

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625050
• Other study ID #: ISEE_2018_TKA_CN
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Manipulation
• Total Knee Replacement

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