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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035435
Receipt No. R000040365
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
Date of disclosure of the study information 2019/01/10
Last modified on 2019/01/03

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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
Last 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
1st 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://upload.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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