UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016625
Receipt number 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 09:33:39

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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 or person

Institute

Suzuka University of Medical Science

Institute

Department

Personal name



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

Value
https://center6.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