MedDataX Logo

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

NCT ID: NCT06059612

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2025-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Superior Cluneal Nerve Entrapment

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Superior cluneal nerve nerve entrapment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

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

Group Type EXPERIMENTAL

injection

Intervention Type PROCEDURE

steroid injection into superior cluneal nerve

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

injection

steroid injection into superior cluneal nerve

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25551470 (View on PubMed)

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.

Reference Type RESULT
PMID: 27669049 (View on PubMed)

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.

Reference Type RESULT
PMID: 27008294 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLU-1

Identifier Type: -

Identifier Source: org_study_id