UMIN-CTR Clinical Trial

Basic information
Public title	Effect of low-frequency electrical stimulation therapy combined with far-infrared irradiation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Acronym	Effect of local modulation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Scientific Title	Effect of low-frequency electrical stimulation therapy combined with far-infrared irradiation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Scientific Title:Acronym	Effect of local modulation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Region	Japan

Condition
Condition	A considerable number of patients with whiplash-associated disorders (WAD) report variable and indefinite symptoms in the whole body, despite there being no evidence of direct injuries in organs other than the neck. However, little is known about the mechanism or management.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine the effect of daily physical therapies by low-frequency electrical stimulation therapy combined with far-infrared irradiation to the cervical muscles of WAD patients during hospitalization.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Self-rated records in the medical interview sheets on the representative 22 whole-body symptoms at admission
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Daily physical therapies by low-frequency electrical stimulation therapy combined with far-infrared irradiation to the cervical muscles
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	10 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Among patients over the age of 10, who visited Tokyo Neurological Center and Matsi Hospital with WAD after motor vehicle accidents, patients who are resistant to outpatient care based on their reporting of one or more indefinite symptoms in the whole body besides neck or shoulder symptoms and needing hospitalization for further treatment are enrolled. Admission and discharge are decided by consent between patients and physicians in charge, independent of the severity of concerns.
Key exclusion criteria	1) Patients who were hospitalized for more than 90 days. 2) Patients with a history of any of the aforementioned symptoms before the motor vehicle accident. 3) Patients with cervical spondylosis, disk degeneration or herniation, ligament ossification, spinal deformity or scoliosis on plain radiographs and MRI at admission
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Kawaguchi
Organization	Tokyo Neurological Center
Division name	Orthopaedics and Spine Department
Zip code
Address	Toranomon 4-1-17, Minato-ku, Tokyo 105-0001, Japan
TEL	+81-35776-1200
Email	kawaguchi0126@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Kawaguchi
Organization	Tokyo Neurological Center
Division name	Orthopaedics and Spine Department
Zip code
Address	Toranomon 4-1-17, Minato-ku, Tokyo 105-0001, Japan
TEL	+81-35776-1200
Homepage URL
Email	kawaguchi0126@gmail.com

Sponsor
Institute	Tokyo Neurological Center and Matsui Hospital
Institute
Department

Funding Source
Organization	There is no funding associated with this study from outside of Tokyo Neurological Center and Matsui Hospital.
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
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	2019 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	The number of symptoms was markedly decreased by the physical therapies during hospitalization. Almost all symptoms showed recovery rates of more than 80% at discharge as compared to those at admission. Although the percentage of patients reporting at least 4 of the representative 22 indefinite symptoms was 99.0% at admission, it decreased to 7.7% at discharge. Sixteen percent of patients recovered completely without any residual symptoms. The mean number of symptoms significantly decreased from 13.1 at admission to 2.0 at discharge. Notably, symptoms other than those in the neck or shoulder recovered to a greater extent than those in the neck or shoulder.
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	Terminated
Date of protocol fixation	2006 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2006 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2018 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2019 Year 01 Month 03 Day
Last modified on	2019 Year 01 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040365

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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