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NCT Number: NCT06059612

Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain

Superior cluneal nerve entrapment (SCN) is a painful symptomatic condition related to compression by the thoracolumbar and gluteal bands of nerve outcrop, above the iliac crest. This syndrome is not considered in the classical differential diagnosis of lumbosacral spine disorders and is almost unknown in Italy.

It is a neuropathic pain, acute, subacute, or chronic, evoked by mechanical stress at the level of the sensory territory corresponding to the superior cluneal nerve, easily found anatomically and evoked at a trigger point on the posterior iliac crest approximately 70mm from the midline and 45mm from the posterior superior iliac spine.

SCN entrapment syndrome represents a not so infrequent syndrome. It is easily framed and treatment is effective in most cases. Therefore, diagnosis and treatment of this syndrome represents an excellent option in all those patients with low back pain that cannot be otherwise framed and resolved.

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Key information

Conditions

Superior Cluneal Nerve Entrapment Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with age between 18 and 99 years
  • male and female sex
  • superior cluneal nerve trigger point positivity at clinical evaluation
  • absence of urgent criteria for spinal surgery

Exclusion criteria

  • patients younger than 18 years old
  • patients who have not given consent to be included in the study
  • patients with negative upper cluneal nerve trigger point - emergency criteria for spine surgery
  • pregnant women - patients allergic to local anesthetic
  • patients with language barrier

Treatment and study plan

Injection

Procedure

steroid injection into superior cluneal nerve

Primary outcomes

  1. numerical rating scale (NRS)

    Time frame: at baseline (day 0)

    NRS is a numerical scale for assessing pain exclusively. It is precisely a numerical scale ranging from 0 to 10 where the degree of pain perceived by the patient is expressed in an increasing manner. The value 0 corresponds to the 'absence of pain, the valor

  2. numerical rating scale (NRS)

    Time frame: after 45 days

    NRS is a numerical scale for assessing pain exclusively. It is precisely a numerical scale ranging from 0 to 10 where the degree of pain perceived by the patient is expressed in an increasing manner. The value 0 corresponds to the 'absence of pain, the valor

  3. Owestry Disability Index (ODI)

    Time frame: at baseline (day 0)

    The ODI score is a scorecard on daily activities and the degree of limitation experienced by the patient with low back pain.

    The form consists of 10 multiple-choice questions (5 options) regarding different aspects of daily life such as pain intensity, personal care, walking, climbing stairs, standing up, sleeping, sexual sphere, social sphere, and traveling. At the end of the assessment, a percentage is assigned where 100% expresses the absence of limitations in performing daily activities. The further away from the maximum threshold, the greater the degree of disability the patient experiences.

  4. Owestry Disability Index (ODI)

    Time frame: after 45 days

    The ODI score is a scorecard on daily activities and the degree of limitation experienced by the patient with low back pain.

    The form consists of 10 multiple-choice questions (5 options) regarding different aspects of daily life such as pain intensity, personal care, walking, climbing stairs, standing up, sleeping, sexual sphere, social sphere, and traveling. At the end of the assessment, a percentage is assigned where 100% expresses the absence of limitations in performing daily activities. The further away from the maximum threshold, the greater the degree of disability the patient experiences.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain: Single-arm Experimental Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
Dec 30, 2025

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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