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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
Sponsored by
Eun Jung Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

First Posted
September 13, 2017
Last Updated
October 18, 2017
Sponsor
Eun Jung Kim
Collaborators
DongGuk University
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
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
Title
EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)
Description
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
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
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.
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
No
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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