UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035445
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Tokyo Neurological Center
Matsui Hospital
Institute
Department

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
URL(English) https://upload.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


Contact us.