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

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

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.

Study Overview

• Status: Completed
• Conditions: Superior Cluneal Nerve Entrapment
• Intervention / Treatment: Procedure: injection

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Superior cluneal nerve entrapment (SCN) will be treated with local steroid injection	Procedure: injection; steroid injection into superior cluneal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale (NRS)	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	at baseline (day 0)
numerical rating scale (NRS)	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	after 45 days
Owestry Disability Index (ODI)	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.	at baseline (day 0)
Owestry Disability Index (ODI)	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.	after 45 days

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Kuniya H, Aota Y, Kawai T, Kaneko K, Konno T, Saito T. Prospective study of superior cluneal nerve disorder as a potential cause of low back pain and leg symptoms. J Orthop Surg Res. 2014 Dec 31;9:139. doi: 10.1186/s13018-014-0139-7.
• Morimoto D, Isu T, Kim K, Chiba Y, Iwamoto N, Isobe M, Morita A. Long-term Outcome of Surgical Treatment for Superior Cluneal Nerve Entrapment Neuropathy. Spine (Phila Pa 1976). 2017 May 15;42(10):783-788. doi: 10.1097/BRS.0000000000001913.
• Bodner G, Platzgummer H, Meng S, Brugger PC, Gruber GM, Lieba-Samal D. Successful Identification and Assessment of the Superior Cluneal Nerves with High-Resolution Sonography. Pain Physician. 2016 Mar;19(3):197-202.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Superior cluneal nerve; nerve entrapment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: CLU-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No