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Efficacy and Safety of Cettum for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Cettum

Traditional indirect moxibustion

Usual care

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Moxibustion

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dongguk University Ilsan Oriental Hospital
Dongguk University Bundang Oriental Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Cettum (Electric moxibustion)

Traditional indirect moxibustion

Usual care

Arm Description

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.

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.

The patients in this group maintain the usual treatment and self-care.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03287570

First Posted

September 13, 2017

Last Updated

October 18, 2017

Sponsor

Eun Jung Kim

Collaborators

DongGuk University

1. Study Identification

Unique Protocol Identification Number

NCT03287570

Brief Title

Efficacy and Safety of Cettum for Knee Osteoarthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 20, 2017 (Actual)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eun Jung Kim

Collaborators

DongGuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee, Moxibustion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cettum (Electric moxibustion)

Arm Type

Experimental

Arm Description

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.

Arm Title

Traditional indirect moxibustion

Arm Type

Active Comparator

Arm Description

Arm Title

Usual care

Arm Type

Other

Arm Description

The patients in this group maintain the usual treatment and self-care.

Intervention Type

Device

Intervention Name(s)

Cettum

Other Intervention Name(s)

Electric moxibustion

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Traditional indirect moxibustion

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

The patients in this group maintain the usual treatment and self-care.

Primary Outcome Measure Information:

Title

Pain NRS (Numeric Rating Scale) change

Description

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

Secondary Outcome Measure Information:

Title

100mm Pain VAS (Visual Analogue Scale)

Description

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

Title

WOMAC (Western Ontario and McMaster Universities) total

Description

Time Frame

6 weeks

Title

EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)

Description

Time Frame

6 weeks

Title

PGA (Patient Global Assessment)

Description

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

Title

Temperature sense threshold

Description

Time Frame

6 weeks

Title

Adverse Events

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eun Jung Kim, Ph. D.

Organizational Affiliation

DongGuk University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dongguk University Ilsan Oriental Hospital

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

10326

Country

Korea, Republic of

Facility Name

Dongguk University Bundang Oriental Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13601

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29506572

Citation

Kang HR, Jung CY, Lee SD, Kim KH, Kim KS, Kim EJ. Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2018 Mar 5;19(1):159. doi: 10.1186/s13063-018-2514-x.

Results Reference

derived

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Efficacy and Safety of Cettum for Knee Osteoarthritis

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