UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056321 |
|---|---|
| Receipt number | R000064353 |
| 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 | 2024/12/02 |
| Last modified on | 2024/11/30 22:37:13 |
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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
neck pain
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to
-prove the efficacy on the posterior neck pain/range of motion (ROM)
-see the change in the spinal blood flow
with the ultrasound-guided fascia hydrorelease (US-FHR) on the ligamentum flavum in patients with neck pain.
In addition, we aim to see the relationship between the change in neck pain (visual analogue scale: VAS)/ROM and the change in spinal blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the range of motion (neck flexion and extension) before and right after the US-FHR (on the first visit)
Key secondary outcomes
Change in the pain VAS (on neck flexion and extension), change in spinal blood flow (Vascular Index: VI) before and right after the US-FHR (on the first visit).
Change in the range of motion (neck flexion and extension) and pain VAS (on neck flexion and extension) on 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 for the ligamentum flavum, which shows tenderness when the cervical spine is in the maximum forward flexion position.
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 over or equal to the 20 years of age with limited cervical spine extension due to posterior neck pain, whose ligamentum flavum and intra-cervical space can be clearly identified by the ultrasound to the tender point one lateral finger on either side of the center line at the level between the spinous processes of the cervical spine.
Key exclusion criteria
Patients with red flag signs, obvious neurological abnormalities, and tenderness of the facet joints under ultrasound are 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-city, Nagano, Japan
TEL
0266-72-1000
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
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kimura pain clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suwa Central Hospital
Address
4300 Tamagawa, Chino-shi, Nagano, Japan
Tel
0266721000
kensyu@suwachuo.jp
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
木村ペインクリニック（群馬県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 02 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064353
