Efficacy and Safety of Cettum for Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion) for patients with knee osteoarthritis.

Detailed Description
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The investigator targets the patients with knee osteoarthritis. After treatment in 3 groups - Cettum treatment, traditional indirect moxibustion treatment, and usual care groups - the investigators will compare the effects of pain relieving and daily performing improvement. So the investigators will confirm the efficacy of Cettum, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Official Title
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Clinical Research on the Efficacy and Safety of Cettum on Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Cettum
* Procedure: Traditional indirect moxibustion
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 40 years of age, but below 70 years of age Presence of knee osteoarthritis diagnosed according to American College of Rheumatology classification criteria and satisfying the following 2 conditions Knee pain when weight load in one or both knees in the last 6 months Knee pain rated >4cm on a 10cm Visual Analog Scale (VAS) Feeling temperature sense to distinguish temperature differences An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months Exclusion Criteria: Trauma to the knee(s) within 6 months prior to enrollment, causing pain or functional problems Surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems A history of intra-articular injection within the last 3 months A physical or laboratory finding indicating presence of an inflammatory arthritis (e.g. rheumatoid arthritis, autoimmune disease) Presence of physical or psychiatric disorder that may affect moxibustion treatment Presence of neurological disorder including paralysis symptoms on local or general sensation A female who is pregnant or is lactating Being afraid of moxibustion treatment or expected to cause side effects When researchers evaluate that it is not appropriate to participate in this clinical test

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cettum (Electric moxibustion)<br>The patients in this group receive Cettum (Electric moxibustion) treatment prescribed by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education. | Device: Cettum<br>* The treatment is applied twice a week for 15 minutes for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Electric moxibustion, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea) is used.<br>* Other names: Electric moxibustion;|
| Active Comparator: Traditional indirect moxibustion<br>The patients in this group receive traditional indirect moxibustion treatment using the same points, applied by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education. | Procedure: Traditional indirect moxibustion<br>* The treatment is applied twice a week for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Traditional indirect moxibustion, Taekeukttum manufactured by Haenglim Seowon Medical Co.(China) is used. A total of three moxibustion cones are applied indirectly to each point per treatment session.<br>|
| Other: Usual care<br>The patients in this group maintain the usual treatment and self-care. | Other: Usual care<br>* The patients in this group maintain the usual treatment and self-care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain NRS (Numeric Rating Scale) change | The Numeric Rating Scale is a unidimensional measure of pain intensity. The 11-point numeric scale ranges from '0' representing 'no pain' to '10' representing 'worst pain imaginable'. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100mm Pain VAS (Visual Analogue Scale) | The patient is asked to indicate their perceived pain intensity along a 100mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. | 6 weeks | 
| WOMAC (Western Ontario and McMaster Universities) total | WOMAC scale is widely used to evaluate the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the joints. The WOMAC scale measures 5 items for pain, 2 for stiffness, and 17 for functional limitation. | 6 weeks | 
| EQ-5D-5L (EuroQol 5-Dimensions 5-Levels) | The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | 6 weeks | 
| PGA (Patient Global Assessment) | The patient may choose to answer the question of how much better the symptom has improved compared to the previous treatment: Very good, Good, Fair, Poor, Very poor. | 6 weeks | 
| Temperature sense threshold | Investigator attaches the temperature sensor to the measurement area and increase or decrease the temperature by starting with reference temperature. Warm pain threshold and heat pain threshold are recorded to compare the difference between the value at baseline and the value at the end of the treatment. | 6 weeks | 
| Adverse Events | Any unpredicted symptoms are checked at each visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Moxibustion