UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035435 |
|---|---|
| Receipt number | R000040365 |
| Scientific Title | Effect of low-frequency electrical stimulation therapy combined with far-infrared irradiation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2019/01/03 22:43:30 |
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Basic information
Public title
Effect of low-frequency electrical stimulation therapy combined with far-infrared irradiation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Acronym
Effect of local modulation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Scientific Title
Effect of low-frequency electrical stimulation therapy combined with far-infrared irradiation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Scientific Title:Acronym
Effect of local modulation of cervical muscles on whole-body indefinite symptoms in patients with whiplash-associated disorders: a prospective case series
Region
| Japan |
Condition
Condition
A considerable number of patients with whiplash-associated disorders (WAD) report variable and indefinite symptoms in the whole body, despite there being no evidence of direct injuries in organs other than the neck. However, little is known about the mechanism or management.
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine the effect of daily physical therapies by low-frequency electrical stimulation therapy combined with far-infrared irradiation to the cervical muscles of WAD patients during hospitalization.
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 the representative 22 whole-body symptoms at admission
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
Daily physical therapies by low-frequency electrical stimulation therapy combined with far-infrared irradiation to the cervical muscles
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 over the age of 10, who visited Tokyo Neurological Center and Matsi Hospital with WAD after motor vehicle accidents, patients who are resistant to outpatient care based on their reporting of one or more indefinite symptoms in the whole body besides neck or shoulder symptoms and needing hospitalization for further treatment are enrolled. Admission and discharge are decided by consent between patients and physicians in charge, independent of the severity of concerns.
Key exclusion criteria
1) Patients who were hospitalized for more than 90 days.
2) Patients with a history of any of the aforementioned symptoms before the motor vehicle accident.
3) Patients with cervical spondylosis, disk degeneration or herniation, ligament ossification, spinal deformity or scoliosis on plain radiographs and MRI at admission
Target sample size
200
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
kawaguchi0126@gmail.com
Sponsor or person
Institute
Tokyo Neurological Center and Matsui Hospital
Institute
Department
Personal name
Funding Source
Organization
There is no funding associated with this study from outside of Tokyo Neurological Center and 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 | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The number of symptoms was markedly decreased by the physical therapies during hospitalization. Almost all symptoms showed recovery rates of more than 80% at discharge as compared to those at admission. Although the percentage of patients reporting at least 4 of the representative 22 indefinite symptoms was 99.0% at admission, it decreased to 7.7% at discharge. Sixteen percent of patients recovered completely without any residual symptoms. The mean number of symptoms significantly decreased from 13.1 at admission to 2.0 at discharge. 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
Terminated
Date of protocol fixation
| 2006 | Year | 04 | Month | 01 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040365
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
