Total Knee ReplacementPhase 2NCT03625050
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
A Phase 2 study of Total Knee Replacement and Manipulation, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
Trial summary
Evaluate the efficacy and safety of Chuna treatment as an adjunctive therapy in patients with moderate pain following total knee replacement. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Knee Replacement, Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to 31 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic Kwandong University International St. Mary'S Hospita
Incheon, 22711
About this study
Evaluate the efficacy and safety of Chuna treatment as an adjunctive therapy in patients with moderate pain following total knee replacement.
- Conditions
- Total Knee Replacement, Manipulation
- Being tested
- Chuna + Usual care(Celecoxib and esomeprazole), Usual care(Celecoxib and esomeprazole)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chuna + Usual care(Celecoxib and esomeprazole)Procedure or surgery
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)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Chuna + Usual care | Experimental | Not described Receives: Procedure: Chuna + Usual care(Celecoxib and esomeprazole) |
| Usual care | Active comparator | Not described Receives: Drug: Usual care(Celecoxib and esomeprazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline K-WOMAC score at week 4
Assess the recovery of knee function
Measured: Week 0, Week 4
Secondary outcomes (10)
Change from baseline K-WOMAC score at every visit
Assess the recovery of knee function
Measured: Week 0, Week 2, Week 4, Week 8
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).
Measured: Week 0, Week 2, Week 4, Week 8
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'.
Measured: Week 0, Week 2, Week 4, Week 8
Change from baseline in Physical Condition related with mobility at every visit
mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second)
Measured: Week 0, Week 2, Week 4, Week 8, Week 12
Change from baseline in Physical Condition related with endurance at every visit
endurance (Sit-to-stand test - STS) (seconds)
Measured: Week 0, Week 2, Week 4, Week 8, Week 12
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).
Measured: Week 0, Week 2, Week 4, Week 8, Week 12
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)
Measured: Week 0, Week 2, Week 4, Week 8, Week 12
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
Measured: Week 0, Week 2, Week 4, Week 8
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.
Measured: Week 0, Week 2, Week 4, Week 8
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
Measured: Week 0, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Nov 2018
- Primary completion30 Dec 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Oriental Medical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Kwandong University
- Responsible party
- Principal investigator, Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
- Investigators
- Yun Kyung Song, PhD, Principal investigator, Gachon university of Gil oriental hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625050
- Sponsor's protocol ID
- ISEE_2018_TKA_CN
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2018
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03625050
- Acronym / sponsor ID
- ISEE_2018_TKA_CN
- Conditions
- Total Knee Replacement, Manipulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gachon University Gil Oriental Medical HospitalUniversity, hospital or other
- Collaborators
- Catholic Kwandong University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of Chuna treatment as an adjunctive therapy in patients with moderate pain following total knee replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chuna + Usual care | Experimental | Procedure: Chuna + Usual care(Celecoxib and esomeprazole) |
| Usual care | Active comparator | Drug: Usual care(Celecoxib and esomeprazole) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Chuna + 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). | Drug | Usual care |
Primary outcome
Change from baseline K-WOMAC score at week 4
Time frame: Week 0, Week 4
Assess the recovery of knee function
10 secondary outcomes
Change from baseline K-WOMAC score at every visit
Time frame: Week 0, Week 2, Week 4, Week 8
Change from baseline EQ-5D score at every visit
Time frame: Week 0, Week 2, Week 4, Week 8
Change from baseline Numeric rating scale score at every visit
Time frame: Week 0, Week 2, Week 4, Week 8
Change from baseline in Physical Condition related with mobility at every visit
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12
Change from baseline in Physical Condition related with endurance at every visit
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12
Change from baseline in Timed Up and Go Test at every visit
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12
Change from baseline in Alternative-Step Test at every visit
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12
Change from baseline in Range of motion score at every visit
Time frame: Week 0, Week 2, Week 4, Week 8
Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
Time frame: Week 0, Week 2, Week 4, Week 8
Cost per QALY(Quality Adjusted Life Years) gained
Time frame: Week 0, Week 4, Week 8, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Kyung Song, PhD principal investigator
Gachon university of Gil oriental hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Total Knee Replacement and Manipulation, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline K-WOMAC score at week 4 (time frame: Week 0, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.