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
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/
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
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
