UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041733
Receipt number R000047636
Scientific Title Effects of Low frequency electric therapy in chronic low back pain
Date of disclosure of the study information 2020/09/14
Last modified on 2021/11/26 10:43:48

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Basic information

Public title

Effects of Low frequency electric therapy in chronic low back pain

Acronym

Effects of Low frequency electric therapy in chronic low back pain

Scientific Title

Effects of Low frequency electric therapy in chronic low back pain

Scientific Title:Acronym

Effects of Low frequency electric therapy in chronic low back pain

Region

Japan


Condition

Condition

chronic low back pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of Low frequency electric therapy in chronic low back pain

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS

Key secondary outcomes

PCS, HADS, SF-MPQ, RDQ, STAI, Pain ROM, FFD


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Low frequency electric therapy (1Hz)

Interventions/Control_2

Low frequency electric therapy (20Hz)

Interventions/Control_3

Low frequency electric therapy (100Hz)

Interventions/Control_4

sham

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

more than 6M in pain

Key exclusion criteria

Taking the medicine

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Kazunori
Middle name
Last name Itoh

Organization

Meiji University of Integrative Medicine

Division name

Acupuncture and Moxibustion

Zip code

629-0392

Address

Hiyoshi-cho, Nantan, Kyoto

TEL

+8177711181

Email

k_itoh@meiji-u.ac.jp


Public contact

Name of contact person

1st name Kazunori
Middle name
Last name Itoh

Organization

Meiji University of Integrative Medicine

Division name

Acupuncture and Moxibustion

Zip code

629-0392

Address

Hiyoshi-cho, Nantan, Kyoto

TEL

+8177711181

Homepage URL


Email

k_itoh@meiji-u.ac.jp


Sponsor or person

Institute

Meiji University of Integrative Medicine

Institute

Department

Personal name



Funding Source

Organization

OMRON HEALTHCARE Co., Ltd.

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-cyo

Tel

+8177711181

Email

k_itoh@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

明治国際医療大学 附属鍼灸センター
オムロンヘルスケア株式会社


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 14 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

Preinitiation

Date of protocol fixation

2020 Year 08 Month 24 Day

Date of IRB

2019 Year 12 Month 02 Day

Anticipated trial start date

2020 Year 09 Month 14 Day

Last follow-up date

2020 Year 12 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

2020 Year 09 Month 08 Day

Last modified on

2021 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name