ClinicalTrials.gg
Status unknownNCT03287570Updated Oct 19, 2017

Efficacy and Safety of Cettum for Knee Osteoarthritis

An interventional study of Cettum and Traditional indirect moxibustion in Osteoarthritis, Knee, sponsored by Eun Jung Kim. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Eun Jung Kim · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Enrolling by invitation — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of — 13 open to participants now, 21 under way, 4 of them phase 3. Osteoarthritis, Knee · Korea, Republic of.

Planned enrollment
40th of 85
138 · median 124
Started
2017
with 2 others
No phase
26 of 96
6 open now
Registered
49th of 96
by date

Among the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, this one is the 40th largest by planned enrollment of the 85 interventional ones that give a count, is one of 3 that started in 2017, is one of 26 with no phase, and was the 49th registered.

Osteoarthritis, Knee

3,294 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

13 of the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 383 Osteoarthritis, Knee studies recruiting now, 177 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 40 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Osteoarthritis, Knee
  • Moxibustion
04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
138 participants (estimated)

Study arms

  • 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

  • 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

  • Other
    Usual care

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

    Other: Usual care

Interventions

  • DeviceCettum

    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.

    Also known as: Electric moxibustion

  • ProcedureTraditional 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.

  • OtherUsual care

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

06

What researchers measure

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'.

    Time frame: 6 weeks

Secondary outcomes

  1. 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'.

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

  3. 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.

    Time frame: 6 weeks

  4. 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.

    Time frame: 6 weeks

  5. 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.

    Time frame: 6 weeks

  6. 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.

    Time frame: 6 weeks

07

Study locations

2 sites
  • Dongguk University Ilsan Oriental Hospital
    Goyang-si, Gyeonggi-do 10326, Korea, Republic of
  • Dongguk University Bundang Oriental Hospital
    Seongnam-si, Gyeonggi-do 13601, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Aug 2018, 11 months after the start.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 11 months is below that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2017
First posted
Sep 19, 2017
StartActual
Sep 20, 2017
Primary completionEst.
Aug 2018
CompletionEst.
Dec 2018
Last update
Oct 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03287570
Lead sponsor
Eun Jung Kim
Collaborators
DongGuk University
Responsible party
Eun Jung Kim (Principle Investigator, DongGuk University) — Sponsor-investigator
First posted
Sep 19, 2017
Start date
Sep 20, 2017
Primary completion
Aug 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Oct 19, 2017

Study contacts

Eun Jung Kim, Ph. D.
principal investigator · DongGuk University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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