Efficacy and Safety of Cettum for Knee Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Cettum; Procedure: Traditional indirect moxibustion; Other: Usual care

• Registration Number: NCT03287570
• Lead Sponsor: Eun Jung Kim

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-19
• Study Start: 2017-09-20
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1. At least 40 years of age, but below 70 years of age

2. 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)

3. Feeling temperature sense to distinguish temperature differences

4. An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form

5. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months

Exclusion Criteria

1. Trauma to the knee(s) within 6 months prior to enrollment, causing pain or functional problems
2. Surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems
3. A history of intra-articular injection within the last 3 months
4. A physical or laboratory finding indicating presence of an inflammatory arthritis (e.g. rheumatoid arthritis, autoimmune disease)
5. Presence of physical or psychiatric disorder that may affect moxibustion treatment
6. Presence of neurological disorder including paralysis symptoms on local or general sensation
7. A female who is pregnant or is lactating
8. Being afraid of moxibustion treatment or expected to cause side effects
9. When researchers evaluate that it is not appropriate to participate in this clinical test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cettum (Electric moxibustion)	Cettum	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.
Traditional indirect moxibustion	Traditional indirect moxibustion	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.
Usual care	Usual care	The patients in this group maintain the usual treatment and self-care.

Primary Outcome Measures

Name	Time	Method
Pain NRS (Numeric Rating Scale) change	6 weeks	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'.

Secondary Outcome Measures

Name	Time	Method
100mm Pain VAS (Visual Analogue Scale)	6 weeks	The patient is asked to indicate their perceived pain intensity along a 100mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'.
WOMAC (Western Ontario and McMaster Universities) total	6 weeks	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.
EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)	6 weeks	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.
Temperature sense threshold	6 weeks	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.
PGA (Patient Global Assessment)	6 weeks	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.
Adverse Events	6 weeks	Any unpredicted symptoms are checked at each visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported.

Trial Locations

Locations (2)

Dongguk University Bundang Oriental Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Dongguk University Ilsan Oriental Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of