UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors-A surface electromyogram study
Acronym	Muscle activity at the movement of chronic low back pain patients
Scientific Title	The relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors-A surface electromyogram study
Scientific Title:Acronym	Muscle activity at the movement of chronic low back pain patients
Region	Japan

Condition
Condition	Chronic low back pain
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the relationship between muscle activity at the movement of chronic low back pain patients and pain-related factors
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle activation of surface EMG (first time and after 1 month)
Key secondary outcomes	Numerical Rating Scale Short-Form McGill Pain Questionnaire 2 Tampa Scale for Kinesiophobia-11 Pain Catastrophizing Scale-4 Hospital Anxiety and Depression Scale The Fremantle Back Awareness Questionnaire Central Sensitization Inventory Pain Self Efficacy Questionnaire-2 Roland-Morris Disability Questionnaire EuroQol 5-dimension

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic low back pain
Key exclusion criteria	Dementia
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hayato Middle name Last name Shigetoh
Organization	Graduate School of Kio University
Division name	Health Science
Zip code	635-0832
Address	Koryo-cho, Kitakaturagi-gun, Nara,Japan
TEL	0745-54-1601
Email	hayato.pt1121@gmail.com

Public contact
Name of contact person	1st name Hayato Middle name Last name Shigetoh
Organization	Graduate School of Kio University
Division name	Health Science
Zip code	635-0832
Address	Koryo-cho, Kitakaturagi-gun, Nara,Japan
TEL	090-7147-8059
Homepage URL
Email	hayato.pt1121@gmail.com

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
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	Graduate School of Kio University
Address	Koryo-cho, Kitakaturagi-gun, Nara,Japan
Tel	0745-54-1601
Email	hayato.pt1121@gmail.com

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	2018 Year 04 Month 25 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	2018 Year 04 Month 23 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 07 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Participants do trunk flextion and extension movement task. Experimenter assesses muscle activity at the movement by a surface electromyogram. Also, participants answer questionnaire that related to pain.

Management information
Registered date	2018 Year 04 Month 25 Day
Last modified on	2021 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036923