Clinical trial NCT03625050: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Total Knee Replacement
Manipulation
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Catholic Kwandong University
First posted: 2018-08-10
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline K-WOMAC score at week 4
timeFrame: Week 0, Week 4
Secondary outcomes:
measure: Change from baseline K-WOMAC score at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8
measure: Change from baseline EQ-5D score at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8
measure: Change from baseline Numeric rating scale score at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8
measure: Change from baseline in Physical Condition related with mobility at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8, Week 12
measure: Change from baseline in Physical Condition related with endurance at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8, Week 12
measure: Change from baseline in Timed Up and Go Test at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8, Week 12
measure: Change from baseline in Alternative-Step Test at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8, Week 12
measure: Change from baseline in Range of motion score at every visit
timeFrame: Week 0, Week 2, Week 4, Week 8
measure: Difference between the EuroQol Visual Analogue Scale (EQ-VAS) at each timepoint and baseline, respectively
timeFrame: Week 0, Week 2, Week 4, Week 8
measure: Cost per QALY(Quality Adjusted Life Years) gained
timeFrame: Week 0, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary'S Hospita
Study officials:
affiliation: Gachon university of Gil oriental hospital
name: Yun Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References: