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

Not Applicable

Recruiting

• Conditions: Superior Cluneal Nerve Entrapment
• Interventions: Procedure: injection

• Registration Number: NCT06059612
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Primary Completion: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	injection	Superior cluneal nerve entrapment (SCN) will be treated with local steroid injection

Primary Outcome Measures

Name	Time	Method
numerical rating scale (NRS)	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
Owestry Disability Index (ODI)	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy