Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058521) titled 'Effectiveness of ultrasound-guided fascia hydrorelease of ligamentum flavum in patients with posterior neck pain and change in the spinal blood flow' on July 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kimura Pain Clinic

Condition: Condition - posterior neck pain Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 14

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066920

Disclaimer: Curated by HT Syndication.