UMIN-CTR Clinical Trial

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
Email	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
Email	5119004@tau.ac.jp

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

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052716