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

NCT03625050 | Completed Phase 2

• 1 other identifier: ISEE_2018_TKA_CN
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline K-WOMAC score at week 4

  Assess the recovery of knee function

  Week 0, Week 4

Secondary Outcomes (10)

• Change from baseline K-WOMAC score at every visit

  Week 0, Week 2, Week 4, Week 8

• Change from baseline EQ-5D score at every visit

  Week 0, Week 2, Week 4, Week 8

• Change from baseline Numeric rating scale score at every visit

  Week 0, Week 2, Week 4, Week 8

• Change from baseline in Physical Condition related with mobility at every visit

  Week 0, Week 2, Week 4, Week 8, Week 12

• Change from baseline in Physical Condition related with endurance at every visit

  Week 0, Week 2, Week 4, Week 8, Week 12

Study Arms (2)

Chuna + Usual care

EXPERIMENTAL

Procedure: Chuna + Usual care(Celecoxib and esomeprazole)

Usual care

ACTIVE COMPARATOR

Drug: Usual care(Celecoxib and esomeprazole)

Interventions

Chuna + Usual care(Celecoxib and esomeprazole) PROCEDURE

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.

Chuna + Usual care

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).

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• Catholic Kwandong University: collaborator

Study Sites (1)

Catholic Kwandong University International St. Mary'S Hospita

Incheon, 22711, South Korea

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yun Kyung Song, PhD

  Gachon university of Gil oriental hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-principle investigator

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 10, 2018
• Study Start: November 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: May 31, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

KR (1)