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

NCT06059612 | Completed

• 1 other identifier: CLU-1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Superior Cluneal Nerve Entrapment

Keywords

Superior cluneal nerve; nerve entrapment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Superior cluneal nerve entrapment (SCN) will be treated with local steroid injection

Procedure: injection

Interventions

injection PROCEDURE

steroid injection into superior cluneal nerve

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (3)

• 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.

  PMID: 25551470 RESULT

• 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.

  PMID: 27669049 RESULT

• 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.

  PMID: 27008294 RESULT

MeSH Terms

Conditions

Nerve Compression Syndromes

Interventions

Injections

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: January 20, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 10, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)