UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of neurnal mechanism in electroacupuncture at myofascial trigger points for musculoskeletal pain.
Acronym	Elucidation of neurnal mechanism in electroacupuncture at myofascial trigger points for musculoskeletal pain.
Scientific Title	Elucidation of neurnal mechanism in electroacupuncture at myofascial trigger points for musculoskeletal pain.
Scientific Title:Acronym	Elucidation of neurnal mechanism in electroacupuncture at myofascial trigger points for musculoskeletal pain.
Region	Japan

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

Objectives
Narrative objectives1	The aim of the study is to investigate the effects of electroacupuncture with different frequencies at myofascial trigger point for musculoskeletal pain on cerebral hemodynamic response using a near infrared spectroscopy (NIRS).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective feeling of pain score (Visual analog Scale)
Key secondary outcomes	Cerebral hemodynamics Pressure Pain threshold

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Electro acupuncture with 2000 Hz at trigger point
Interventions/Control_2	Electro acupuncture with 250 Hz at trigger point
Interventions/Control_3	Electro acupuncture with 5Hz at trigger point
Interventions/Control_4	Electro acupuncture with 2000 Hz at non-trigger point
Interventions/Control_5	Electro acupuncture with 250 Hz at non-trigger point
Interventions/Control_6	Electro acupuncture with 5 Hz at non-trigger point
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects who complain of neck pain. 2) Subjects who had myofascial trigger point located in their trapezius muscle.
Key exclusion criteria	1) Patients with The past history of spinal surgery. 2) Patients with spinal fracture or dislocation. 3) Patients with neurological signs. 4)Patients with analgesics. 5)Patients with complain of systemic pain, or those with a history of rheumatoid arthritis, metastasis such as tumor, fibromyalgia,Tumors of the spine or intervertebral disc, infections, or other diseases responsible for systemic pain. 6) Patient with neck or low back pain due to heart diseases. 7) Pregnant subjects. 8) The presence of malignant tumor, or the past history of the malignant tumor. 9) Patients with psychiatric disorders. 10) Patients with severe osteoporosis. 11) Patients who complain weight loss and fever of unknown cause. 12) Patients who received treatments such as massage, acupuncture, never block, etc, for their back pain at other hospitals or clinics within 1 month from the start of the study. 13) Patients with a history of whiplash injury due to traffic accidents. 14) Patients whom are recognized as inadequate subjects by the experimenters.
Target sample size	78

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

Public contact
1st name of contact person	1st name Middle name Last name Kouich Takamoto
Organization	University of Toyama
Division name	Department of system emotional science
Zip code
Address	2630, Sugitani, Toyama, Japan
TEL	076-434-7218
Homepage URL
Email	ktakamo@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	1)Grants-in-Aid for Scientific Research 2)University of Toyama
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 08 Month 27 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 08 Month 25 Day
Date of IRB	2016 Year 04 Month 27 Day
Anticipated trial start date	2018 Year 08 Month 27 Day
Last follow-up date	2019 Year 04 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 27 Day
Last modified on	2019 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038658