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
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
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
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
