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NCT Number: NCT07712406

Ultrasound-Guided Proximal Superior Cluneal Nerve Block for Superior Cluneal Nerve Entrapment

Superior cluneal nerve entrapment (SCNE) is an underrecognized cause of chronic low back pain and gluteal pain that may mimic lumbar spine disorders. Ultrasound-guided proximal superior cluneal nerve block has increasingly been used in routine clinical practice .Diagnostic superior cluneal nerve block is commonly used to confirm the diagnosis, whereas ultrasound-guided proximal superior cluneal nerve block has emerged as a therapeutic option.

This prospective observational cohort study aims to evaluate the clinical outcomes of ultrasound-guided proximal superior cluneal nerve block in patients with clinically diagnosed superior cluneal nerve entrapment who undergo the procedure as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be assessed at baseline and during follow-up to evaluate treatment outcomes.

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Key information

Conditions

Superior Cluneal Nerve Entrapment Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziosmanpasa Research and Education Hospital

Gaziosmanpaşa, Istanbul, 34255, Turkey (Türkiye)

Location status: Recruiting

Location contact

Tuğçe Yavuz Mollavelioğlu, Medical Doctor

CONTACT

[email protected]

+905056751666

About this study

Superior cluneal nerve entrapment (SCNE) is an increasingly recognized cause of chronic low back pain that may be overlooked or misdiagnosed as lumbar radiculopathy or other degenerative lumbar disorders. Accurate diagnosis is essential because patients with SCNE may benefit from targeted peripheral nerve interventions rather than treatments directed at the lumbar spine.

Ultrasound-guided proximal superior cluneal nerve block has emerged as a practical technique for both diagnostic confirmation and therapeutic management of SCNE. Compared with landmark-based approaches, ultrasound guidance enables real-time visualization of relevant anatomical structures and standardized needle placement. Despite increasing clinical use, prospective evidence evaluating the clinical outcomes of this technique remains limited.

This prospective observational cohort study will enroll patients with clinically diagnosed superior cluneal nerve entrapment who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be evaluated at baseline and at 1- and 3-month follow-up visits using validated clinical outcome measures.

The primary objective is to evaluate changes in pain intensity following ultrasound-guided proximal superior cluneal nerve block. Secondary objectives include evaluating changes in disability and neuropathic pain characteristics after treatment and documenting the clinical outcomes of this intervention during routine practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years.
  • Chronic low back and/or gluteal pain persisting for at least 3 months.
  • Localized pain and/or tenderness over the posterior iliac crest.
  • At least 50% reduction in pain intensity following diagnostic superior cluneal nerve block.
  • Failure of conservative treatment.
  • Ability to provide written informed consent.

Exclusion criteria

  • Previous superior cluneal nerve surgery.
  • Active local or systemic infection.
  • Bleeding disorders or contraindications to the procedure.
  • Allergy to study medications.
  • Pregnancy.
  • Severe cognitive impairment or inability to complete study assessments.
  • Additional interventional pain procedures involving the affected region during follow-up.

Treatment and study plan

Ultrasound-Guided Proximal Superior Cluneal Nerve Block

Procedure

Ultrasound-guided proximal superior cluneal nerve block will be performed as part of routine clinical care in patients with clinically diagnosed superior cluneal nerve entrapment. The proximal superior cluneal nerve will be targeted using a standardized ultrasound-guided interfascial technique. A standardized injectate will be administered according to the study protocol. All procedures will be performed by an experienced pain physician using the same technique for all participants.

Primary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline, 1 month, and 3 months

    Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), a unidimensional pain assessment tool ranging from 0 (no pain) to 10 (the worst imaginable/unbearable pain). Patients will be asked to select the number that best reflects their pain intensity. The change in NRS pain score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.

Secondary outcomes

  1. Change in Oswestry Disability Index (ODI) Score

    Time frame: Baseline, 1 month, and 3 months

    Oswestry Disability Index (ODI): Change in disability related to low back pain assessed using the Oswestry Disability Index (ODI).The validated and reliability-tested Turkish version of the ODI will be used in this study.The ODI consists of 10 items, each scored from 0 to 5, yielding a maximum total raw score of 50.The total score is converted to a percentage using the following formula:ODI percentage = (Total score / 50) × 100

    Higher percentage scores indicate greater disability. Disability levels are interpreted as follows:

    0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerated symptoms A decrease in ODI percentage score indicates improvement in functional status. The change in ODI score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.

  2. Douleur Neuropathique 4 (DN4)

    Time frame: Baseline, 1 month, and 3 months

    Neuropathic pain will be assessed using the Douleur Neuropathique en 4 Questions (DN4) questionnaire, a validated 10-item screening tool with scores ranging from 0 to 10, where higher scores indicate a greater likelihood of neuropathic pain and a score of ≥4 is considered indicative of neuropathic pain. The change in DN4 score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.

  3. Treatment Response

    Time frame: 1 month and 3 months

    Treatment response will be defined as a ≥50% reduction in NRS pain score compared with baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuğba Bayraktar Çelebioğlu, Medical Doctor

CONTACT

[email protected]

Tuğçe Yavuz Mollavelioğlu, Medical Doctor

CONTACT

[email protected]

+905056751666

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Clinical Outcomes of Ultrasound-Guided Proximal Superior Cluneal Nerve Block in Patients With Superior Cluneal Nerve Entrapment

Acronym: PRO-SCN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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