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Completed

NCT Number: 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

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

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Key information

Conditions

Total Knee Replacement Manipulation

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Catholic Kwandong University International St. Mary'S Hospita

Incheon, 22711, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Change from baseline K-WOMAC score at week 4

    Time frame: Week 0, Week 4

    Assess the recovery of knee function

Secondary outcomes

  1. Change from baseline K-WOMAC score at every visit

    Time frame: Week 0, Week 2, Week 4, Week 8

    Assess the recovery of knee function

  2. Change from baseline EQ-5D score at every visit

    Time frame: Week 0, Week 2, Week 4, Week 8

    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).

  3. Change from baseline Numeric rating scale score at every visit

    Time frame: Week 0, Week 2, Week 4, Week 8

    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'.

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

    Time frame: Week 0, Week 2, Week 4, Week 8, Week 12

    mobility (5 meters walking test at comfortable speed - 5mWT) (meters/second)

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

    Time frame: Week 0, Week 2, Week 4, Week 8, Week 12

    endurance (Sit-to-stand test - STS) (seconds)

  6. Change from baseline in Timed Up and Go Test at every visit

    Time frame: Week 0, Week 2, Week 4, Week 8, Week 12

    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).

  7. Change from baseline in Alternative-Step Test at every visit

    Time frame: Week 0, Week 2, Week 4, Week 8, Week 12

    a functional test measuring clinical balance performance, and it has been shown to predict fall risk among elderly subjects (seconds)

  8. Change from baseline in Range of motion score at every visit

    Time frame: Week 0, Week 2, Week 4, Week 8

    Compare flexion and extension angle using long arm goniometer between experimental and comparator group

  9. 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

    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.

  10. Cost per QALY(Quality Adjusted Life Years) gained

    Time frame: Week 0, Week 4, Week 8, Week 12

    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

Sponsors and collaborators

Lead sponsor

Gachon University Gil Oriental Medical Hospital

Other

Collaborators

  • Catholic Kwandong University

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 10, 2018
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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