Efficacy and Safety of Cettum for Knee Osteoarthritis
Clinical Research on the Efficacy and Safety of Cettum on Knee Osteoarthritis
1 other identifier
interventional
138
1 country
2
Brief Summary
The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion) for patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
September 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 19, 2017
October 1, 2017
11 months
September 13, 2017
October 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
100mm Pain VAS (Visual Analogue Scale)
6 weeks
WOMAC (Western Ontario and McMaster Universities) total
6 weeks
EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)
6 weeks
PGA (Patient Global Assessment)
6 weeks
Temperature sense threshold
6 weeks
- +1 more secondary outcomes
Study Arms (3)
Cettum (Electric moxibustion)
EXPERIMENTALThe 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
ACTIVE COMPARATORThe 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
OTHERThe patients in this group maintain the usual treatment and self-care.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eun Jung Kimlead
- DongGuk Universitycollaborator
Study Sites (2)
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, 13601, South Korea
Related Publications (1)
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.
PMID: 29506572DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun Jung Kim, Ph. D.
DongGuk University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
September 13, 2017
First Posted
September 19, 2017
Study Start
September 20, 2017
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
October 19, 2017
Record last verified: 2017-10