UMIN-CTR Clinical Trial

Basic information
Public title	Involvement of Cervical Muscle Lesions and Parasympathetic Nervous System in Chronic Fatigue Syndrome
Acronym	CFS
Scientific Title	Involvement of Cervical Muscle Lesions and Parasympathetic Nervous System in Chronic Fatigue Syndrome
Scientific Title:Acronym	Involvement of Cervical Muscle Lesions and Parasympathetic Nervous System in Chronic Fatigue Syndrome: CFS
Region	Japan

Condition
Condition	To clarify the involvement of cervical muscle lesions as well as the parasympathetic nervous system in the chronic fatigue (CFS) patients
Classification by specialty	Medicine in general Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the involvement of cervical muscle lesions as well as the parasympathetic nervous system in the CFS patients, this prospective study examined the effects of local modulation of cervical muscles by physical therapies in patients with CFS.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Number of patients complaining cervical disorders in the self-rated records on the medical interview sheets before and after the physical treatments 2) Pupil light reflex parameters (the initial pupil diameter before the stimulus, the percentage of constriction rate and the velocity of the constriction) before and after the physical treatments
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	During hospitalization, all patients underwent local modulation of the cervical muscles through physical therapies: low-frequency electrical stimulation therapy and far-infrared irradiation for 15 minutes 2 or 3 times daily
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	1) CFS patients over the age of 10, who visited our institutions from May 2006 through Jan 2019. 2) Resistant to outpatient care 3) Patients who were hospitalized for 5 to 120 days were enrolled.
Key exclusion criteria	1) Diagnosed to have specific diseases in other organs after admission 2) Underwent surgeries of the cervical spine 3) Received other pharmacological or non-pharmacological treatments in addition to the physical therapies at their insistence 4) Quit the physical therapies due to adverse events that were judged to be therapy-related by the physicians 5) Dischaged themselves from the hospital based on their own judgement with unknown reasons.
Target sample size	1500

Research contact person
Last name of lead principal investigator	1st name Hiroshi Middle name Last name Kawaguchi
Organization	Tokyo Neurological Center
Division name	Orthopaedics and Spine Department
Zip code	105-0001
Address	Toranomon 4-1-17, Minato-ku, Tokyo, Japan
TEL	+81-90-3002-5156
Email	kawaguchi0126@gmail.com

Public contact
1st name of contact person	1st name Hiroki Middle name Last name Fujii
Organization	Tokyo Neurological Center
Division name	Office
Zip code	105-0001
Address	Toranomon 4-1-17, Minato-ku, Tokyo 105-0001, Japan
TEL	+81-35776-1200
Homepage URL
Email	fujii@tokyo-neurological-center.com

Sponsor
Institute	There is no outside sponsor associated with this study.
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	Tokyo Neurological Center
Address	Toranomon 4-1-17, Minato-ku, Tokyo 105-0001, Japan
Tel	+81-35776-1200
Email	fujii@tokyo-neurological-center.com

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 05 Month 01 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	1500
Results
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 11 Month 01 Day
Date of IRB	2007 Year 02 Month 01 Day
Anticipated trial start date	2007 Year 05 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 01 Day
Last modified on	2019 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041736