Efficacy and Safety of Cettum for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03287570
• Other study ID #: DUBH2017-0002
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 13, 2017
• Last updated: October 18, 2017
• Start date: September 20, 2017
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 138
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Cettum
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.

Procedure:
• Traditional indirect moxibustion
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.

Other:
• Usual care
The patients in this group maintain the usual treatment and self-care.

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Oriental Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Dongguk University Bundang Oriental Hospital	Seongnam-si	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Eun Jung Kim	Dongguk University Bundang Oriental Hospital, Dongguk University Ilsan Oriental Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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