Efficacy and Safety of Cettum for Knee Osteoarthritis

NCT ID: NCT03287570

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Osteoarthritis, Knee Moxibustion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cettum

Intervention Type DEVICE

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 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.

Group Type ACTIVE_COMPARATOR

Traditional indirect moxibustion

Intervention Type PROCEDURE

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 care

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

Group Type OTHER

Usual care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Usual care

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Electric moxibustion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DongGuk University

OTHER

Sponsor Role collaborator

Eun Jung Kim

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eun Jung Kim

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eun Jung Kim, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dongguk University Ilsan Oriental Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status

Dongguk University Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29506572 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DUBH2017-0002

Identifier Type: -

Identifier Source: org_study_id