UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiroshi Kawaguchi
Organization	Tokyo Neurological Center
Division name	Orthopaedics and Spine Department
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	Hiroshi Kawaguchi
Organization	Tokyo Neurological Center
Division name	Orthopaedics and Spine Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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