UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015637
Receipt number R000009353
Scientific Title Effectiveness of Press Tack Needle among patients with knee pain.
Date of disclosure of the study information 2014/11/10
Last modified on 2014/11/08 07:46:33

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Basic information

Public title

Effectiveness of Press Tack Needle among patients with knee pain.

Acronym

Effectiveness of Press Needle among elderly with chronic knee pain
-Double blind randomized controlled trial-

Scientific Title

Effectiveness of Press Tack Needle among patients with knee pain.

Scientific Title:Acronym

Effectiveness of Press Needle among elderly with chronic knee pain
-Double blind randomized controlled trial-

Region

Japan


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this trial was to clarify the effectiveness of Press Needle on the subjective knee pain, disease-specific quality of life and health related qol.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

WOMAC (western ontario mcmaster universities osteoarthritis index), japanese version .

Key secondary outcomes

Visual analog scale
SF-8
Questionnaire on adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

A computer program was used to randomly allocate 100 participants with chronic knee pain to either a Press Needle group or a Sham Press Needle group. Participants in both groups received intervention at the painful points "5 points", they were pressed for two days. The Press Needle used in this trial was Press Needle manufactured by SEIRIN Inc "length;0.6mm, diameter;0.2mm". For the Sham Press Needle group, Sham Press Needle by which the needle was removed was used. Evaluation was performed before the first intervention, after the two days, seven days and one month.

Interventions/Control_2

In the second intervention, not using Sham Press Needle, both groups intervene by Press Needle. Other procedure is the same as that of first time intervention.

Interventions/Control_3


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1,Man and Woman aged 65 and over.
2,Kellgren-Lawrence clasification, grad 1 or more.
3,Duration of disease more than 3 months.
4,Injection in an articulation genus is not carried out within four weeks.
5,Tere is no acupuncture to knee within three months.
6,A neurological unusual view is not seen.

Key exclusion criteria

1,Central-nerves system disease (stroke, Parkinson disease dementia etc.)
2,Orthopedic disease (osteoarthritis of the hip, foot sprain etc.)
3,Autoimmune disease (chronic rheumatoid arthritis, systematic lupus erythematosus.)
4,Psychiatric disorder.
5,Rash in the plaster easy.
6,When it has allergy to metal.
7,When an inflammatory reaction is strong.
8,When it is judged for reasons of mind and body that the participation in this study is impossible.



Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name junichi Watanabe

Organization

Project Research Institutes, Comprehensive Research Organization, WASEDA University.

Division name

Research Institute for Elderly Helth.

Zip code


Address

Mikashima2-579-15,Tokorozawa,Saitama Prefecture. Isao Muraoka, the labolatory of Sports Sciences, WASEDA University.

TEL

09043366896

Email

ptiwemonat@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name junichi watanabe

Organization

Project research institutes, comprehensive research organization, WASEDA university

Division name

Research Institute for Elderly Helth.

Zip code


Address

2-579-15, Mikajima, Tokorozawa city, Saitama.

TEL

09043366896

Homepage URL


Email

ptiwemonat@yahoo.co.jp


Sponsor or person

Institute

Project research institutes, comprehensive research organization, WASEDA university

Institute

Department

Personal name



Funding Source

Organization

WASEDA University, Ibuka Fund Project.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

かとう内科外来(愛媛県)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 10 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

For the continuous change after the two and seven days assessment, there was a significant difference in changes in the vas scores, womac japanese version, sf-8 both groups. Between two groups, there was a significant difference in change in the PCS score (SF-8) with more favorable results in the Press Needle group than in the Sham Press Needle group after one month.

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

Preinitiation

Date of protocol fixation

2012 Year 07 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 11 Month 08 Day

Last modified on

2014 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name