The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion) for patients with knee osteoarthritis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
138
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.
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.
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, South Korea
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, South Korea
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'.
Time frame: 6 weeks
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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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The patients in this group maintain the usual treatment and self-care.
Time frame: 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.
Time frame: 6 weeks