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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043725
Receipt No. R000049927
Scientific Title Effects of acupuncture on patients with non-specific low back pain -The world's first double-blind placebo-controlled clinical trial-
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/24

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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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