UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012683
Receipt number R000014670
Scientific Title JAPAN Multicenter, Randomized, Open-label, Parallel-Group Comparison Study on Clinical Efficacy and Responders to Acupuncture for Osteoarthritis of the Knee
Date of disclosure of the study information 2013/12/25
Last modified on 2023/12/05 17:58:37

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Basic information

Public title

JAPAN Multicenter, Randomized, Open-label, Parallel-Group Comparison Study on Clinical Efficacy and Responders to Acupuncture for Osteoarthritis of the Knee

Acronym

JEAK study

Scientific Title

JAPAN Multicenter, Randomized, Open-label, Parallel-Group Comparison Study on Clinical Efficacy and Responders to Acupuncture for Osteoarthritis of the Knee

Scientific Title:Acronym

JEAK study

Region

Japan


Condition

Condition

osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A meta analysis has found that patients with osteoarthritis of the knee treated with acupuncture show better clinical improvement than patients treated with ordinary therapies such as NSAIDs or NSAIDs + exercise when compared in a short period of time. The analysis has also indicated that acupuncture is more effective than sham procedures, although the difference is not statistically significant.
Yet, many unresolved questions there still remain regarding how much stimulus on the affected sites can induce a response to acupuncture therapy and from what types of patients.
The purpose of this study is, together working with an orthopedist, to elucidate what makes a patient with osteoarthritis of the knee a responder or non-responder to treatment with acupuncture.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

VAS

Key secondary outcomes

WOMAC SF-36


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Thumb Tack Needles

Interventions/Control_2

sham

Interventions/Control_3

acupuncture

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

45 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

1)Kellgren and Lawrence grade 2 or lower
2)No intra-articular injection within 4weeks prior to enrollment
3)No history of acupuncture therapy within 6 months prior to enrollment
4)No evident disease in hip joints and lumbar spine parts impairing walking
5)No evident trauma, arthritis not caused by age related alteration such as septic arthritis, and history of surgery
6)Patients must have oral communication ability; can provide written informed consent signed by him/her or from a family member under their free will after receiving full explanation of the study.

Key exclusion criteria

1)Patients who do not consent to the nature of the study
2)Patients who are currently participating in other study(ies)
3)Patients who have any change in their current treatment drugs, exercise therapy or orthosis for knee pain during the study period
4)Patients with internal derangement of the knee joint such as a meniscal tear detected using MRI.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Yamaguchi

Organization

Saitama Medical University

Division name

The Center for Oriental and Integrated Medicine,Saitama Medical University, Saitama, Japan.

Zip code

049-276-1193

Address

38,Morohongo,Moroyamamachi,Iruma-gun,Saitama

TEL

049-276-1193

Email

sayama@saitama-med.ac.jp


Public contact

Name of contact person

1st name satoru
Middle name
Last name Yamaguchi

Organization

Saitama Medical University

Division name

The Center for Oriental and Integrated Medicine,Saitama Medical University, Saitama, Japan.

Zip code

3500845

Address

38,Morohongo,Moroyamamachi,Iruma-gun,Saitama

TEL

049-276-1193

Homepage URL


Email

sayama@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

The Japan Society of Acupuncture and Moxibustion

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Japanese Red Cross Ogawa Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Center for Oriental and lntegrated Medicine Saitama Medical University

Address

38 Morohongo, Moroyama-machi, Saitama Prefecture

Tel

049-276-1193

Email

sayama@saitama-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 11 Month 01 Day

Date of IRB

2014 Year 04 Month 01 Day

Anticipated trial start date

2014 Year 01 Month 06 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 25 Day

Last modified on

2023 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014670


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name