UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043725 |
|---|---|
| Receipt number | 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 | 2025/05/12 15:10:33 |
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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
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
yajima@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Science
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
akiyama@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
Completed
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
Other related information
The last follow-up date for this clinical study was set for 03/31/2024; however, it has been delayed for the following reasons.
1) From 2020 to 2022, the spread of SARS-CoV-2 infection led to restrictions on the number of people allowed in the treatment room as a countermeasure. This situation caused significant delays due to the lack of staff to measure electromyograms and to check the operation of double-blind acupuncture needles by research collaborators.
2) For this infectious disease, the study participants and the staff of this research were infected with SARS-CoV-2; therefore, planned studies had to be post-phone.
3) The X-rays of the participants revealed the scoliosis and osteoarthritis of the lumbar spine, which are exclusion criteria.
Management information
Registered date
| 2021 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049927
