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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000035435 |
Receipt No. | 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 |
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 |
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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 |
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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.
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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 |
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Interventions/Control_1 | Daily physical therapies by low-frequency electrical stimulation therapy combined with far-infrared irradiation to the cervical muscles | |
Interventions/Control_2 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 200 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Tokyo Neurological Center and Matsui Hospital |
Institute | |
Department |
Funding Source | |
Organization | There is no funding associated with this study from outside of Tokyo Neurological Center and Matsui Hospital. |
Organization | |
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Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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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. |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Terminated | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | 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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Research case data | |
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