UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037520
Receipt number R000042781
Scientific Title The effect of circular acupuncture and self-exercises on the prevention of locomotive syndrome
Date of disclosure of the study information 2019/07/29
Last modified on 2019/07/29 15:32:38

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Basic information

Public title

The effect of circular acupuncture and self-exercises on the prevention of locomotive syndrome:a randomized controlled trial

Acronym

The effect of circular acupuncture and self-exercises on the prevention of locomotive syndrome

Scientific Title

The effect of circular acupuncture and self-exercises on the prevention of locomotive syndrome

Scientific Title:Acronym

The effect of circular acupuncture and self-exercises on the prevention of locomotive syndrome

Region

Japan


Condition

Condition

locomotive syndrome

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the combined effects of circular acupuncture and self-exercises on the prevention of locomotive syndrome

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual analogue scale
before and after the intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

self-exercises
1 month

Interventions/Control_2

self-exercises and circular acupuncture
1 month

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

participants with chronic low back pain

Key exclusion criteria

participants suspected of having coexisting low back pain due to reasons other than musculoskeletal disorders, and participants who had received other treatment for low back pain within 1 month of the start of the trial

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Motohiro
Middle name
Last name Inoue

Organization

Meiji University of Integrative Medicine

Division name

Faculity of Acupuncture and Moxibustion

Zip code

6290392

Address

Hiyoshi-cho, Nantan-shi, Kyoto, Japan

TEL

0771721181

Email

mo_inoue@meiji-u.ac.jp


Public contact

Name of contact person

1st name Motohiro
Middle name
Last name Inoue

Organization

Meiji University of Integrative Medicine

Division name

Faculity of Acupuncture and Moxibustion

Zip code

6290392

Address

Hiyoshi-cho, Nantan-shi, Kyoto, Japan

TEL

0771721181

Homepage URL


Email

mo_inoue@meiji-u.ac.jp


Sponsor or person

Institute

Meiji University of Integrative Medicine

Institute

Department

Personal name



Funding Source

Organization

Meiji University of Integrative Medicine

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

Meiji University of Integrative Medicine

Address

Hiyoshi-cho, Nantan-shi, Kyoto, Japan

Tel

0771721181

Email

mo_inoue@meiji-u.ac.jp


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

2019 Year 07 Month 29 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

2018 Year 04 Month 01 Day

Date of IRB

2018 Year 05 Month 01 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 29 Day

Last modified on

2019 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042781


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name