UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025301 |
|---|---|
| Receipt number | R000029105 |
| Scientific Title | Difference between therapeutic effects of deep and superficial acupuncture needle insertion for shoulder stiffness:A randomized controlled clinical trial |
| Date of disclosure of the study information | 2016/12/16 |
| Last modified on | 2016/12/16 14:35:27 |
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Basic information
Public title
Difference between therapeutic effects of deep and superficial acupuncture needle insertion for shoulder stiffness:A randomized controlled clinical trial
Acronym
Difference between therapeutic effects of deep and superficial acupuncture needle insertion for shoulder stiffness:A randomized controlled clinical trial
Scientific Title
Difference between therapeutic effects of deep and superficial acupuncture needle insertion for shoulder stiffness:A randomized controlled clinical trial
Scientific Title:Acronym
Difference between therapeutic effects of deep and superficial acupuncture needle insertion for shoulder stiffness:A randomized controlled clinical trial
Region
| Japan |
Condition
Condition
Shoulder stiffness
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of superficial and deep insertion of acupuncture needles for shoulder stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analogue scale(VAS).
Key secondary outcomes
shoulder pain and disability index(SPADI).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture treatment is applied once a week for 4 weeks.
Needles are placed at sites of the tender points. A needle is inserted 10-20mm.
Interventions/Control_2
Acupuncture treatment is applied once a week for 4 weeks.
Needles are placed at sites of the tender points. A needle is inserted 5mm.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have chronic shoulder stiffness.
Key exclusion criteria
1. Patients who have neurological abnormality findings.
2. Patients who have internal organ disease.
3. Patients who have mild symptom.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Inoue |
Organization
Meiji University of Integrative Medicine, Kyoto, Japan
Division name
Department of Clinical Acupuncture and Moxibustion
Zip code
Address
Hiyoshicho, Nantan-city, Kyoto 629-0392, Japan
TEL
0771-72-1181
mo_inoue@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Inoue |
Organization
Meiji University of Integrative Medicine, Kyoto, Japan
Division name
Department of Clinical Acupuncture and Moxibustion
Zip code
Address
Hiyoshicho, Nantan-city, Kyoto 629-0392, Japan
TEL
0771-72-1181
Homepage URL
mo_inoue@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine, Kyoto, Japan
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Integrative Medicine, Kyoto, Japan
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 16 | Day |
Last modified on
| 2016 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029105
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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