Osteoarthritis, KneeNCT03287570
Efficacy and Safety of Cettum for Knee Osteoarthritis
A study testing Cettum and Traditional indirect moxibustion in people with Osteoarthritis, Knee, run by Eun Jung Kim at 2 sites in South Korea.
Trial summary
The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion) for patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cettum and Traditional indirect moxibustion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Sep 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, 10326
Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, 13601
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cettum, Traditional indirect moxibustion, Usual care
- Keywords
- Osteoarthritis, Knee, Moxibustion
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CettumDevice
Also called Electric moxibustion
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.
Traditional indirect moxibustionProcedure or surgery
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.
Usual careOther
The patients in this group maintain the usual treatment and self-care.
| Study group | Role | What they receive |
|---|---|---|
| Cettum (Electric moxibustion) | Experimental | 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. Receives: Device: Cettum |
| Traditional indirect moxibustion | Active comparator | 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. Receives: Procedure: Traditional indirect moxibustion |
| Usual care | Other | The patients in this group maintain the usual treatment and self-care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 6 weeks
Secondary outcomes (6)
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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start20 Sep 2017
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eun Jung Kim
- Sponsor type
- University, hospital or other
- Collaborators
- DongGuk University
- Responsible party
- Sponsor-investigator, Eun Jung Kim, DongGuk University
- Investigators
- Eun Jung Kim, Ph. D., Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287570
- Sponsor's protocol ID
- DUBH2017-0002
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29506572
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Efficacy and Safety of Cettum on Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03287570
- Acronym / sponsor ID
- DUBH2017-0002
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Moxibustion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Eun Jung KimUniversity, hospital or other
- Collaborators
- DongGuk University
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cettum (Electric moxibustion) | Experimental | Device: CettumThe 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 comparator | Procedure: Traditional indirect moxibustionThe 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 | Other | Other: Usual careThe patients in this group maintain the usual treatment and self-care. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CettumAlso: Electric moxibustionThe 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. | Device | Cettum (Electric moxibustion) |
| Traditional indirect moxibustionThe 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. | Procedure or surgery | Traditional indirect moxibustion |
| Usual careThe patients in this group maintain the usual treatment and self-care. | Other | Usual care |
Primary outcome
Pain NRS (Numeric Rating Scale) change
Time frame: 6 weeks
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 secondary outcomes
100mm Pain VAS (Visual Analogue Scale)
Time frame: 6 weeks
WOMAC (Western Ontario and McMaster Universities) total
Time frame: 6 weeks
EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)
Time frame: 6 weeks
PGA (Patient Global Assessment)
Time frame: 6 weeks
Temperature sense threshold
Time frame: 6 weeks
Adverse Events
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Derived from this study: PubMed 29506572Kang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Jung Kim, Ph. D. principal investigator
DongGuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cettum and Traditional indirect moxibustion in people with Osteoarthritis, Knee, run by Eun Jung Kim at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain NRS (Numeric Rating Scale) change (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.