UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042256
Receipt number R000046656
Scientific Title Randomized controlled trial of acupuncture and pelvic belt wearing on postpartum low back pain
Date of disclosure of the study information 2020/10/27
Last modified on 2021/03/17 10:07:49

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Basic information

Public title

Randomized controlled trial of acupuncture and pelvic belt wearing on postpartum low back pain

Acronym

Effects of acupuncture on postpartum low back pain

Scientific Title

Randomized controlled trial of acupuncture and pelvic belt wearing on postpartum low back pain

Scientific Title:Acronym

Effects of acupuncture on postpartum Low back pain

Region

Japan


Condition

Condition

Postnatal low back pain

Classification by specialty

Obstetrics and Gynecology Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of acupuncture on postpartum low back pain with usual care (pelvic belt) and usual care in a randomized controlled trial

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

100 mm Visual Analogue Scale (VAS)

Key secondary outcomes

Roland-Morris Disability Questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Acupuncture at least twice a day from 2 to 4 days after delivery

Interventions/Control_2

wearing a low back pain band.

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

18 years-old <=

Age-upper limit

42 years-old >=

Gender

Female

Key inclusion criteria

Pregnant women with lumbago complaints at 36 weeks gestation

Key exclusion criteria

Those who have had a Caesarean delivery, those who have gestational hypertension and unstable blood pressure during pregnancy and after delivery

Target sample size

24


Research contact person

Name of lead principal investigator

1st name keiko
Middle name
Last name Tsujiuchi

Organization

Serie Womens Health Care Acupuncture and moxibustion room

Division name

Clinical

Zip code

231-0063

Address

1-5-704 Hanasaki-cho Naka-ku Yokohama-shi, Kanagawa, Japan

TEL

0452629562

Email

czw06225@nifty.com


Public contact

Name of contact person

1st name Shunji
Middle name
Last name Sakaguchi

Organization

Kansai University of Health Sciences

Division name

Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences

Zip code

590-0433

Address

2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan

TEL

072-453-8409

Homepage URL


Email

sakaguti@kansai.ac.jp


Sponsor or person

Institute

Kansai University of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

General Incorporated Association Japan Hot Spring Climate Physics Society

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

Serie Womens Health Care Acupuncture and moxibustion room

Address

1-5-704 Hanasaki-cho Naka-ku Yokohama-shi, Kanagawa, Japan

Tel

0452625550

Email

info@aerie89.com


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

医療法人定生会 谷口病院(大阪府)


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 27 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

22

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

Completed

Date of protocol fixation

2020 Year 09 Month 23 Day

Date of IRB

2020 Year 10 Month 21 Day

Anticipated trial start date

2020 Year 10 Month 27 Day

Last follow-up date

2020 Year 12 Month 29 Day

Date of closure to data entry

2021 Year 02 Month 28 Day

Date trial data considered complete

2021 Year 03 Month 01 Day

Date analysis concluded

2021 Year 03 Month 20 Day


Other

Other related information



Management information

Registered date

2020 Year 10 Month 27 Day

Last modified on

2021 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name