NCT07372430|Recruiting
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Sponsor study identifier
observational
54
1 country
1
Study Start
December 12, 2025
Actual (reported)Primary Completion
July 1, 2026
Actual (reported)Study Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Superior cluneal nerve (SCN) entrapment is an underdiagnosed cause of chronic low back and gluteal pain. Although diagnostic nerve block is considered the gold standard for confirming SCN entrapment, there is no consensus regarding the optimal injection approach. This prospective observational study aims to compare the clinical effectiveness of proximal and distal ultrasound-guided SCN block techniques in patients diagnosed with SCN entrapment. Pain intensity and functional outcomes will be evaluated over the follow-up period to assess differences between the two approaches.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2025
Actual (reported)January 6, 2026
Actual (reported)January 28, 2026
Actual (reported)July 1, 2026
Actual (reported)August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Visual Analog Scale (VAS)
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
Baseline, 1 month, and 3 months
Oswestry Disability Index (ODI)
Baseline, 1 month, and 3 months
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Baseline, 1 month, and 3 months
Short Form-12 Health Survey (SF-12)
Baseline, 1 month, and 3 months
Baseline Postural and Radiological Characteristics in Patients with Superior Cluneal Nerve Entrapment
Baseline (pre-intervention)
Ultrasound-guided proximal interfascial (plane block) approach for suspected superior cluneal nerve entrapment.
Ultrasound-guided distal perineural approach for suspected superior cluneal nerve entrapment.
The ultrasound probe will be placed over the posterior superior iliac crest to visualize the fibro-osseous tunnel where the superior cluneal nerve passes. Using an in-plane approach, the needle will be advanced toward the target area, and the injection will be administered at the fascial exit point of the nerve. A total injectate volume of 5 cc (2 cc bupivacaine, 2 cc dexamethasone, and 1 cc normal saline) will be administered. All procedures will be performed in the prone position under standard aseptic conditions.
The study population will consist of adult patients aged 18 to 75 years presenting with chronic low back and/or gluteal pain lasting longer than three months, who are clinically suspected of having superior cluneal nerve entrapment based on physical examination findings. Eligible participants will be those who have not responded to conservative treatment and who attend the Algology Outpatient Clinic during the study period. Only patients with unilateral symptoms who meet all inclusion and exclusion criteria and who provide written informed consent will be included in the study.
Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospita
Istanbul, 34255, Turkey (Türkiye)
Nielsen TD, Moriggl B, Barckman J, Jensen JM, Kolsen-Petersen JA, Soballe K, Borglum J, Bendtsen TF. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100174. doi: 10.1136/rapm-2018-100174. Online ahead of print.
Bodner G, Platzgummer H, Meng S, Brugger PC, Gruber GM, Lieba-Samal D. Successful Identification and Assessment of the Superior Cluneal Nerves with High-Resolution Sonography. Pain Physician. 2016 Mar;19(3):197-202.
Tugce Yavuz Mollavelioglu, MD
Gaziosmanapasa Educational and Training Hospital
First Submitted
January 6, 2026
First Posted
January 28, 2026
Study Start
December 12, 2025
Actual (reported)Primary Completion
July 1, 2026
Actual (reported)Patients randomized to the proximal injection group will undergo ultrasound-guided injection above the iliac crest level. The target will be the plane beneath the posterior layer of the thoracolumbar fascia. Using an in-plane approach, the injectate will be delivered into the interfascial plane. A total injectate volume of 5 cc (2 cc bupivacaine, 2 cc dexamethasone, and 1 cc normal saline) will be administered under ultrasound guidance. Patient positioning and aseptic conditions will be identical to those used in the distal perineural injection group.
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Study Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 15, 2026
Record last verified: 2026-01
Individual participant data will not be shared due to institutional data protection policies and the absence of participant consent for data sharing beyond the scope of the current study.
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Source: ClinicalTrials.gov.
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