UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046299 |
|---|---|
| Receipt number | R000052716 |
| Scientific Title | Factors affecting the response of acupuncture on nonspecific low back pain. - Focus on the Roland-Morris Disability Questionnaire - |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2022/01/08 12:01:06 |
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Basic information
Public title
Factors affecting the response of acupuncture on nonspecific low back pain.
- Focus on the Roland-Morris Disability Questionnaire -
Acronym
Factors affecting the response of acupuncture on nonspecific low back pain.
- Focus on the Roland-Morris Disability Questionnaire -
Scientific Title
Factors affecting the response of acupuncture on nonspecific low back pain.
- Focus on the Roland-Morris Disability Questionnaire -
Scientific Title:Acronym
Factors affecting the response of acupuncture on nonspecific low back pain.
- Focus on the Roland-Morris Disability Questionnaire -
Region
| Japan |
Condition
Condition
Non-Specific Low Back Pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study that factors affecting the response of acupuncture on nonspecific low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Visual Analogue Scale (VAS) of pain induced by trunk movements.
(Evaluation before and after acupuncture.)
Key secondary outcomes
Before acupuncture, RDQ, patient information (gender, age, height, weight, BMI, etc.)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with non-specific low back pain who received acupuncture treatment at the Tokyo Ariake Medical University Acupuncture Center
2. Those who can induce pain during trunk movement
Key exclusion criteria
1. Patients with specific low back pain
2. Patients with lower neurological symptoms of low back pain.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Fujimoto |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL
+08-3-6703-7014
5119004@tau.ac.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Nagumo |
Organization
Tokyo Ariake University of Medical and Health Science, Tokyo, Japan
Division name
Graduate School of Health Science
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL
+08-3-6703-7014
Homepage URL
5119004@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical and Health Science
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
Tokyo Ariake University of Medical and Health Science
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel
+08-3-6703-7014
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case-control study
The subjects were patients with non-specific low back pain who visited the Tokyo Ariake Medical University Acupuncture Center from January 2013 to June 11, 2021, and who satisfy selection criteria.
The evaluation items are VAS of pain induced by trunk movements before and after treatment, and RDQ and patient information before treatment.
Management information
Registered date
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052716
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
