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

Gachon University Gil Oriental Medical Hospital

Status and phase

Completed

Phase 2

Conditions

Manipulation

Total Knee Replacement

Treatments

Drug: Usual care(Celecoxib and esomeprazole)

Procedure: Chuna + Usual care(Celecoxib and esomeprazole)

Study type

Interventional

Funder types

Other

Identifiers

ISEE_2018_TKA_CN

Details and patient eligibility

About

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

Enrollment

22 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.