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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016625
Receipt No. R000019196
Scientific Title Single-arm study of acupuncture treatment on Low Back Pain
Date of disclosure of the study information 2015/02/26
Last modified on 2015/02/25

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Basic information
Public title Single-arm study of acupuncture treatment on Low Back Pain
Acronym Effects of acupuncture on Low Back Pain
Scientific Title Single-arm study of acupuncture treatment on Low Back Pain
Scientific Title:Acronym Effects of acupuncture on Low Back Pain
Region
Japan

Condition
Condition Low Back Pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compared the effect of acupuncture treatment with Visual Analogue Scale and Oswestry Disability Index in patients with Low Back Pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale
Key secondary outcomes Oswestry Disability Index

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 acupuncture treatment
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Low back pain patients.
2. Pain lasting for six months or longer.
3. Subjects who gave the written informed consent.
Key exclusion criteria Patients who deemed inappropriate by acupuncturist as the object of the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Suzuki
Organization Suzuka University of Medical Science
Division name Faculty of Oriental Medicine
Zip code
Address Kishioka1001-1, Suzuka, 510-0293
TEL 059-383-8991
Email s_suzuki@suzuka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Suzuki
Organization Suzuka University of Medical Science
Division name Faculty of Oriental Medicine
Zip code
Address Kishioka1001-1, Suzuka, 510-0293
TEL 059-383-8991
Homepage URL
Email s_suzuki@suzuka-u.ac.jp

Sponsor
Institute Suzuka University of Medical Science
Institute
Department

Funding Source
Organization Suzuka University of Medical Science
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 26 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
2013 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 21 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
2015 Year 02 Month 25 Day
Last modified on
2015 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019196

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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