UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058521 |
|---|---|
| Receipt number | R000066920 |
| Scientific Title | Effectiveness of ultrasound-guided fascia hydrorelease of ligamentum flavum in patients with posterior neck pain and change in the spinal blood flow. |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/19 09:14:58 |
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Basic information
Public title
Effectiveness of ultrasound-guided fascia hydrorelease of ligamentum flavum in patients with posterior neck pain and change in the spinal blood flow.
Acronym
Effectiveness of ultrasound-guided fascia hydrorelease of ligamentum flavum in patients with posterior neck pain and change in the spinal blood flow.
Scientific Title
Effectiveness of ultrasound-guided fascia hydrorelease of ligamentum flavum in patients with posterior neck pain and change in the spinal blood flow.
Scientific Title:Acronym
Effectiveness of ultrasound-guided fascia hydrorelease of ligamentum flavum in patients with posterior neck pain and change in the spinal blood flow.
Region
| Japan |
Condition
Condition
posterior neck pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ultrasound-guided fascial hydrorelease (US-FHR) targeting the tender points of the ligamentum flavum in patients with neck and shoulder pain.
To assess changes in intramedullary spinal blood flow before and after US-FHR and examine the correlation with improvements in range of motion (ROM) and pain visual analog scale (VAS) scores.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: Change in cervical range of motion (ROM) during flexion and extension before and after US-FHR.
Key secondary outcomes
Secondary outcomes:
- Change in pain visual analog scale (VAS) during cervical flexion and extension before and after US-FHR.
- Change in vascularity index (VI) of intramedullary spinal blood flow measured by SMI (Superb Microvascular Imaging) mode on ultrasound.
- Change in cervical ROM and pain VAS during flexion and extension at the second visit.
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
| Maneuver |
Interventions/Control_1
US-FHR will be performed on the ligamentum flavum at the site of maximal tenderness while the cervical spine is in maximal flexion.
If multiple tender points are present, the site with the greatest tenderness will be selected as the intervention point.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with restricted cervical extension due to posterior neck pain will be evaluated. Using ultrasound, the ligamentum flavum will be identified at a point one fingerbreadth lateral to the midline at the interspinous level of the cervical spine, on either the left or right side, depending on the site of symptoms. Under ultrasound guidance, the presence of tenderness in the ligamentum flavum will be confirmed. In the same ultrasound plane, the visibility of the intradural spinal cord space will also be assessed. Patients who exhibit both tenderness in the ligamentum flavum and good visibility of the intradural space on ultrasound will be included.
Key exclusion criteria
To exclude conditions requiring urgent intervention, as well as radiculopathy and facet joint syndrome, patients presenting with red flag signs, obvious neurological findings, or facet joint tenderness on ultrasound-guided palpation will be excluded.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Masei |
| Middle name | |
| Last name | Suda |
Organization
Suwa Central Hospital
Division name
Rheumatology
Zip code
3918503
Address
4300, Tamagawa, Chino-shi, Nagano, Japan
TEL
0266721000
maseisuda@gmail.com
Public contact
Name of contact person
| 1st name | Masei |
| Middle name | |
| Last name | Suda |
Organization
Suwa Central Hospital
Division name
Rheumatology
Zip code
391-8503
Address
4300, Tamagawa, Chino-shi, Nagano, Japan
TEL
0266721000
Homepage URL
maseisuda@gmail.com
Sponsor or person
Institute
Kimura Pain Clinic
Institute
Department
Personal name
Masei Suda
Funding Source
Organization
Japanese Non-surgical Orthopedics Society (JNOS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suwa Central Hospital
Address
4300, Tamagawa, Chino-shi, Nagano, Japan
Tel
0266721000
maseisuda@gmail.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
長野県
Institutions
Institutions
木村ペインクリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 22 | 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
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066920
