UMIN-CTR Clinical Trial

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

Non-specific low back pain

Classification by specialty

Medicine in general	Orthopedics	Laboratory medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Tokyo Ariake University of Medical and Health Science

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

akiyama@tau.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京有明医療大学附属鍼灸センター(東京都)

Date of disclosure of the study information

2021

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

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

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

03

Month

24

Day

Last modified on

2024

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049927