Efficacy and Safety of Cettum for Knee Osteoarthritis

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

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

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Cettum; Procedure: Traditional indirect moxibustion; Other: Usual care

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
      • Dongguk University Ilsan Oriental Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13601
      • Dongguk University Bundang Oriental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cettum (Electric moxibustion); 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.	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.; Other Names: Electric moxibustion
Active Comparator: 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.	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.	Other: Usual care; The patients in this group maintain the usual treatment and self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eun Jung Kim
• Collaborators: DongGuk University
• Investigators: Principal Investigator: Eun Jung Kim, Ph. D., DongGuk University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Osteoarthritis, Knee; Moxibustion
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DUBH2017-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No