UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063257 |
|---|---|
| Receipt number | R000070819 |
| Scientific Title | Cervical Muscle Stiffness and Clinical Outcomes in Patients with Spontaneous Intracranial Hypotension: An Exploratory Comparative Study |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/13 17:23:12 |
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Basic information
Public title
Cervical Muscle Stiffness and Clinical Outcomes in Patients with Spontaneous Intracranial Hypotension: An Exploratory Comparative Study
Acronym
Cervical Muscle Stiffness and Clinical Outcomes in Patients with Spontaneous Intracranial Hypotension: An Exploratory Comparative Study
Scientific Title
Cervical Muscle Stiffness and Clinical Outcomes in Patients with Spontaneous Intracranial Hypotension: An Exploratory Comparative Study
Scientific Title:Acronym
Cervical Muscle Stiffness and Clinical Outcomes in Patients with Spontaneous Intracranial Hypotension: An Exploratory Comparative Study
Region
| Japan |
Condition
Condition
Spontaneous intracranial hypotension
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to measure cervical muscle stiffness in patients with spontaneous intracranial hypotension (SIH) and compare it with that of healthy controls. In addition, changes in cervical muscle stiffness before and after epidural blood patch treatment will be evaluated, and their associations with clinical outcomes, including pain intensity, quality of life (QOL), and psychological factors, will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure will be the change in cervical muscle stiffness, expressed as the mean shear wave velocity (SWV mean), from before to after epidural blood patch treatment.
Key secondary outcomes
Secondary outcomes
Between-group differences in cervical muscle stiffness between patients with spontaneous intracranial hypotension (SIH) and healthy controls.
Neck pain and headache intensity assessed using the Visual Analogue Scale (VAS).
Neck-related disability assessed using the Neck Disability Index (NDI).
Quality of life assessed using the EuroQol 5-Dimension (EQ-5D).
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS).
Associations between cervical muscle stiffness and VAS, NDI, EQ-5D, and HADS scores.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals diagnosed with spontaneous intracranial hypotension (SIH) according to the ICHD-3. Specifically, participants must present with persistent orthostatic headache and associated symptoms such as neck pain, dizziness, visual disturbances, and fatigue, with evidence of cerebrospinal fluid leakage on MRI and/or radionuclide cisternography.
Aged 18 years or older at enrollment.
Able to provide written informed consent.
Key exclusion criteria
Individuals with neuromuscular disorders or cervical spine diseases that may affect cervical muscle stiffness.
Individuals who are pregnant or breastfeeding.
Individuals for whom the date of symptom onset, medical history, or medication history is unavailable or cannot be adequately ascertained.
Individuals who lack the capacity to provide informed consent due to severe psychiatric disorders, dementia, or other conditions.
Individuals who request exclusion from participation in this study.
Individuals deemed unsuitable for participation by the principal investigator for any other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Murahashi |
Organization
Saitama Medical University Hospital
Division name
Traditional Medicine
Zip code
3500495
Address
38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1111
murahashi.masaki@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Murahashi |
Organization
Saitama Medical University Hospital
Division name
Traditional medicine
Zip code
3500495
Address
38 Morohongo Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1111
Homepage URL
murahashi.masaki@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
Tel
049-276-1111
saitama-med@esct.bvits.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
| 2026 | Year | 10 | Month | 14 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070819
