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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015637
Receipt No. 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

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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
Institute Project research institutes, comprehensive research organization, WASEDA university
Institute
Department

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
URL(English) https://upload.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


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