UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035435
Receipt number 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 22:43:30

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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

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 or person

Institute

Tokyo Neurological Center and Matsui Hospital

Institute

Department

Personal name



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

Value
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