UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041733
Receipt No. 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 2020/09/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 5
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 (58Hz)
Interventions/Control_4 Low frequency electric therapy (100Hz)
Interventions/Control_5 no treatment
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 3M in pain
Key exclusion criteria Taking the medicine
Target sample size 50

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
Institute Meiji University of Integrative Medicine
Institute
Department

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-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

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
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.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


Contact us.