Ultrasound-Guided Proximal Superior Cluneal Nerve Block for Superior Cluneal Nerve Entrapment (PRO-SCN)

July 25, 2026 updated by: Gaziosmanpasa Research and Education Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Gaziosmanpaşa, Istanbul, Turkey (Türkiye), 34255
        • Recruiting
        • Gaziosmanpasa Research and Education Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with chronic low back and/or gluteal pain and a positive diagnostic superior cluneal nerve block response who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will be prospectively followed for clinical outcomes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients With Superior Cluneal Nerve Entrapment Undergoing Ultrasound-Guided Proximal Superior Clune
Adults with clinically diagnosed superior cluneal nerve entrapment undergoing ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will undergo baseline clinical assessment followed by follow-up evaluations at 1 and 3 months.
Procedure: Ultrasound-Guided Proximal Superior Cluneal Nerve Block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month and 3 months
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.
Baseline, 1 month, and 3 months
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.
Baseline, 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 25, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEDIPOL-EC-846-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet made a final decision regarding individual participant data (IPD) sharing. Data sharing will be considered after study completion in accordance with institutional policies, ethical requirements, and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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