UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain: Randomized controlled trial
Acronym	Elucidation of the neuronal mechanism of analgesic action of TENS for chronic musculoskeletal pain
Scientific Title	Elucidation of the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain: Randomized controlled trial
Scientific Title:Acronym	Elucidation of the neuronal mechanism of analgesic action of TENS for chronic musculoskeletal pain
Region	Japan

Condition
Condition	Chronic neck pain
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To shed light on the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain, we examine the changes in resting-state functional connectivity before and after electrical stimulation therapy in patients with musculoskeletal pain using Near-infrared spectroscopy and electroencephalography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Cerebral hemodynamics (Oxy-Hb, Deoxy-Hb, Total-Hb)
Key secondary outcomes	Neuronal Activity Visual Analog Scale (VAS) Pain Pressure Threshold (PPT)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Trigger point
Interventions/Control_2	Non-Trigger point
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients over 20 years of age 2)Patients who complain of neck pain over 3month from the onset 3)Patients with trapezius myofascial trigger points
Key exclusion criteria	1)Patients with a history of neck surgery 2)Patients with cervical fracture or dislocation 3)Patients with an abnormality in neurologic findings 4)Patients who take analgesic drug 5)Patients who have a history of complaints of systemic pain or a history of rheumatoid arthritis, metastasis such as tumor, fibromyalgia, tumors of the spine or intervertebral disc, infectious diseases, or systemic pain 6)pregnant woman 7)Patients who had treatments (massage, acupuncture, nerve block treatment, etc.) for neck pain within one month 8) Patients with a history of whiplash injury caused by traffic accidents
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Hisao Middle name Last name Nishijo
Organization	University of Toyama
Division name	Department of system emotional science
Zip code	930-0194
Address	2630,Sugitani, Toyama, Japan
TEL	076-434-7218
Email	nishijo@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Hibi
Organization	University of Toyama
Division name	Department of anesthesiology
Zip code	930-0194
Address	2630,Sugitani, Toyama, Japan
TEL	076-434-7218
Homepage URL
Email	d1661011@ems.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee, University of Toyama
Address	2630,Sugitani, Toyama, Japan
Tel	076-434-7681
Email	rinri@adm.u-toyama.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	2019 Year 08 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	Preinitiation
Date of protocol fixation	2019 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 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

Management information
Registered date	2019 Year 07 Month 31 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042813