UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053612 |
|---|---|
| Receipt number | R000061028 |
| Scientific Title | Effectiveness of ultrasound-guided fascia hydrorelease around the blood vessels in patient with stiff neck and shoulder pain. |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2024/08/15 11:52:01 |
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Basic information
Public title
Effectiveness of ultrasound-guided fascia hydrorelease around the blood vessels in patient with stiff neck and shoulder pain.
Acronym
Effectiveness of ultrasound-guided fascia hydrorelease around the blood vessels in patient with stiff neck and shoulder pain.
Scientific Title
Effectiveness of ultrasound-guided fascia hydrorelease around the blood vessels in patient with stiff neck and shoulder pain.
Scientific Title:Acronym
Effectiveness of ultrasound-guided fascia hydrorelease around the blood vessels in patient with stiff neck and shoulder pain.
Region
| Japan |
Condition
Condition
Myofascial pain syndrome of the neck
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we performed ultrasound-guided fascia hydrorelease around the transverse carotid artery that feeds the trapezius and levator scapulae muscles and other neck tissues in patients diagnosed with stiff neck pain and myofascial pain syndrome (MPS) in the neck. We want to clarify whether or not pain symptoms can be improved by ultrasound-guided fascia hydrorelease around the transverse cervical artery or the dorsal scapular artery that feeds the trapezius, levator scapulae, and other neck tissues.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patient is evaluated by listening to the pain Visual Analog Scale (VAS) at rest and during neck movement to see if neck pain improves by performing a fascia hydrorelease targeting the transverse cervical artery or the dorsal scapular artery.
Key secondary outcomes
We will evaluate whether fascia hydrorelease targeting the transverse carotid artery or the dorsal scapular artery improves blood flow by analyzing ultrasound findings and local temperature changes in the affected area.
A questionnaire will be used to evaluate whether or not the activities of living (ADL) are improved by fascia hydrorelease.
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
Ultrasound-guided fascia hydrorelease around the transverse carotid artery or the dorsal scapular artery
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with neck pain and upper back pain with pain as the main complaint who visited Kimura Pain Clinic or Isesaki Municipal Hospital from the date of approval by the Ethics Committee to March 31, 2026, and who have been diagnosed with MPS and have complaints of pain with a maximum VAS of 30 mm or more during movement.
Key exclusion criteria
Patients who cannot give consent for this study will be excluded from the study. Patients who have difficulty with the withdrawal of anticoagulant/antithrombotic drugs, patients with bleeding tendencies, and patients with signs of infection at the site where fascia hydrorelease is to be performed will be excluded from the study. Patients will also be excluded from the study if it is difficult to assess blood flow in the transverse carotid artery using ultrasound equipment. Patients scheduled to undergo a fascia hydrorelease at another site during the study period as treatment will be excluded from the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tadanao |
| Middle name | |
| Last name | Hiroki |
Organization
Isesaki Municipal Hospital
Division name
Department of Anesthesiology
Zip code
372-0817
Address
12-1, Tsunatorihon-machi, Isesaki, Gunma, Japan.
TEL
0270255022
t-hiroki@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadanao |
| Middle name | |
| Last name | Hiroki |
Organization
Isesaki Municipal Hospital
Division name
Department of Anesthesiology
Zip code
372-0817
Address
12-1, Tsunatorihon-machi, Isesaki, Gunma, Japan.
TEL
0270255022
Homepage URL
t-hiroki@gunma-u.ac.jp
Sponsor or person
Institute
Isesaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Non-surgical Orthopedics Society
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
Isesaki Municipal Hospital Ethical Review Board
Address
12-1, Tsunatorihon-machi, Isesaki, Gunma, Japan.
Tel
0270255022
office@hospital.isesaki.gunma.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
伊勢崎市民病院（群馬県）、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 | 02 | 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
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061028
