Proximal Versus Distal Superior Cluneal Nerve Block in Entrapment Neuropathy

NCT07372430 | Recruiting

• 1 other identifier: 1496
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cluneal Syndrome

Keywords

Neuralgia; Peripheral Nerve Entrapment; low back pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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)

Study Arms (2)

Proximal SCN Injection (Ultrasound-Guided)

Ultrasound-guided proximal interfascial (plane block) approach for suspected superior cluneal nerve entrapment.

Procedure: Ultrasound-guided proximal superior cluneal nerve injection

Distal SCN Injection (Ultrasound-Guided)

Ultrasound-guided distal perineural approach for suspected superior cluneal nerve entrapment.

Procedure: Ultrasound-guided distal superior cluneal nerve injection

Interventions

Ultrasound-guided distal superior cluneal nerve injection PROCEDURE

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.

Distal SCN Injection (Ultrasound-Guided)

Ultrasound-guided proximal superior cluneal nerve injection PROCEDURE

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.

Proximal SCN Injection (Ultrasound-Guided)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age between 18 and 75 years
• Chronic low back and/or gluteal pain lasting longer than 3 months
• Localized point tenderness and/or paresthesia on palpation over the unilateral posterior iliac crest
• Clinical suspicion of superior cluneal nerve entrapment based on physical examination
• Failure to respond to conservative treatment
• Ability and willingness to provide written informed consent

You may not qualify if:

• Active local or systemic infection
• Cognitive impairment or psychiatric disorders interfering with study participation
• History of malignancy or cancer-related pain
• Uncontrolled diabetes mellitus or severe comorbid conditions adversely affecting general health
• Pregnancy
• Known allergy to the medications used in the injection
• Prominent radicular pain associated with neurological deficit
• History of interventional procedures applied to the lumbar region within the last 6 months
• Initiation of another lumbar interventional or medical treatment during the follow-up period
• Suspected bilateral superior cluneal nerve entrapment
• Sphincter dysfunction related to neurological disease
• Bleeding diathesis or coagulation disorders

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospita

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Nielsen TD, Moriggl B, Barckman J, et al. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med Epub. 2019;44(8):772-780. doi:10.1136/rapm-2018-100174

  BACKGROUND

• Bodner G, Platzgummer H, Meng S, Bruve muayeneer GM, Lieba-Samal D. Successful identification and assessment of the superior cluneal nerves with high-resolution sonography. Pain Physician. 2016;19(3):197-202.

  BACKGROUND

MeSH Terms

Conditions

Neuralgia; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Tugce Yavuz Mollavelioglu, MD

  Gaziosmanapasa Educational and Training Hospital

  STUDY CHAIR

Central Study Contacts

Tugce Yavuz Mollavelioglu, M.D

CONTACT

+905056751666; tugceyavuz@hotmail.com.tr

tugba bayraktar celebioglu, M.D

CONTACT

+905444720367; t.byrktr@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 28, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)