UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035445
Receipt number R000040382
Scientific Title Effect of physical therapies by low-frequency electrical stimulation therapy and far-infrared irradiation to cervical muscles of patients with cervical disorders reporting whole-body indefinite symptoms
Date of disclosure of the study information 2019/01/20
Last modified on 2019/01/04 19:34:54

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Basic information

Public title

Effect of physical therapies by low-frequency electrical stimulation therapy and far-infrared irradiation to cervical muscles of patients with cervical disorders reporting whole-body indefinite symptoms

Acronym

Effect of modulation of cervical muscles on indefinite and variable symptoms in the whole body

Scientific Title

Effect of physical therapies by low-frequency electrical stimulation therapy and far-infrared irradiation to cervical muscles of patients with cervical disorders reporting whole-body indefinite symptoms

Scientific Title:Acronym

Effect of modulation of cervical muscles on indefinite and variable symptoms in the whole body

Region

Japan


Condition

Condition

Patients with variable and indefinite symptoms in the whole body, whose etiology or management remains unclarified, often accompany pain or stiffness of cervical muscles.

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines the effect of local modulation of cervical muscles by daily physical therapies using low-frequency electrical stimulation therapy and far-infrared irradiation to the cervical muscles in patients with cervical disorders reporting whole-body indefinite symptoms.

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 representative 30 whole-body symptoms at admission and discharge

Key secondary outcomes

The pupil reflex parameters representing parasympathetic nerve function at admission and discharge


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

All patients undergo daily physical therapies by low-frequency electrical stimulation therapy and far-infrared irradiation to the cervical muscles during hospitalization.

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 complaining cervical pain or stiffness, we enroll patients who are resistant to outpatient care by reporting at least two indefinite symptoms in the whole body besides the cervical disorders, and needing hospitalization. These include the following 29 symptoms (total 30 including cervical pain or stiffness): headache, shoulder pain or stiffness, vertigo or dizziness, lightheaded or wobble, palpation, chest tightness, dazzling, vision loss, asthenopia, dry eyes, dry mouth, nausea or stomachache, diarrhea or constipation, thermoregulation disorder, perspiration disorder, poor circulation, lingering cold, unstable blood pressure, unknown fever, general fatigue, depression, insomnia, bedridden, lethargic, weather dependent, distraction, uneasy feeling, irritability, and impatience. Patients who were hospitalized for 5 to 120 days were enrolled.

Key exclusion criteria

1) Patients who underwent other treatments including surgery, medication, injection, external fixation, or cervical traction.
2) Patients who were diagnosed to be specific diseases in other organs after admission.
3) Patients who were hospitalized for less than 5 days and more than 120 days.

Target sample size

2000


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

https://tokyo-neurological-center.com/en/

Email

kawaguchi0126@gmail.com


Sponsor or person

Institute

Tokyo Neurological Center
Matsui Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Neurological Center
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 20 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

The number of symptoms was significantly decreased by the physical therapies during hospitalization. Almost all of the representative 30 symptoms showed recovery rates of greater than 50% (p<0.001). 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

Completed

Date of protocol fixation

2005 Year 12 Month 31 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

2019 Year 12 Month 10 Day


Other

Other related information

In four participants with a decrease of the number of symptoms by 15 or more, all showed marked improvement of the pupil reflex parameters.


Management information

Registered date

2019 Year 01 Month 04 Day

Last modified on

2019 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name