UMIN-CTR Clinical Trial

Basic information
Public title	Effects of acupuncture on patients with non-specific low back pain -The world's first double-blind placebo-controlled clinical trial-
Acronym	Clinical study on the effect of acupuncture on low back pain
Scientific Title	Effects of acupuncture on patients with non-specific low back pain -The world's first double-blind placebo-controlled clinical trial-
Scientific Title:Acronym	Clinical study on the effect of acupuncture on low back pain
Region	Japan

Condition
Condition	Non-specific low back pain
Classification by specialty	Medicine in general Orthopedics Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of acupuncture on non-specific low back pain patients with abnormal excitability of muscle will be compared using electromyograms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surface electromyography
Key secondary outcomes	1)X-ray findings 2)Japanese version of Roland-Morris Disability Questionnaire 3)Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) 4)Intensity of low back pain (Visual Analogue Scale) 5)Japanese version of Massachusetts General Hospital Acupuncture Sensation Scale 6)Practitioner and patient guess at the needle authenticity (Visual Analogue Scale)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Acupuncture stimulation that uses penetrating needle with a depth of 5 mm to 20 mm for the acupuncture points of the lumbar region, gluteal region and lower limb.
Interventions/Control_2	Pressing acupuncture stimulation that uses skin-touch placebo needle with a compression depth of 2 mm (needle that the acupuncture tip comes out 2 mm from the acupuncture tube and presses the skin without sticking to the skin) for the acupuncture points of the lumbar region, gluteal region and lower limb.
Interventions/Control_3	No-touch acupuncture stimulation that uses no-touch placebo needles (needles the tip of which cannot reach the skin) for acupuncture points in the lumbar region, buttocks and lower limb.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with nonspecific low back pain with high excitability of the erector spinae muscles
Key exclusion criteria	1) Patients with underlying diseases related to low back pain (infection, lumbar herniation, spinal tumor, spinal cord tumor, rheumatism, lumbar vertebral compression fracture, osteoporosis, other central or peripheral neuropathy, circulatory disturbance of lower lumbar limb and other internal organ disease). 2) Those who are scheduled to receive treatment or therapy for the purpose of improving low back pain within 24 hours of after acupuncture treatment. 3) Pregnant subjects. 4) Persons with low back pain related to menstruation, etc.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroyoshi Middle name Last name Yajima
Organization	Tokyo Ariake University of Medical and Health Science
Division name	Department of Acupuncture and Moxibustion
Zip code	135-0063
Address	135-0063 Japan 2-9-1 Ariake Koto-ku, Tokyo
TEL	+08-3-6703-7000
Email	yajima@tau.ac.jp

Public contact
Name of contact person	1st name Hiroyoshi Middle name Last name Yajima
Organization	Tokyo Ariake University of Medical and Health Science
Division name	Department of Acupuncture and Moxibustion
Zip code	135-0063
Address	135-0063 Japan 2-9-1 Ariake Koto-ku, Tokyo
TEL	+08-3-6703-7000
Homepage URL
Email	yajima@tau.ac.jp

Sponsor
Institute	Tokyo Ariake University of Medical and Health Science
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Ariake University of Medical and Health Sciences IRB
Address	2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel	+08-3-6703-7000
Email	kida@tau.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	東京有明医療大学附属鍼灸センター(東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 01 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	2017 Year 07 Month 19 Day
Date of IRB	2018 Year 04 Month 23 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 10 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	2021 Year 03 Month 24 Day
Last modified on	2021 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049927

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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