Clinical trial NCT06059612: Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain
Official title: Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain: Single-arm Experimental Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Superior Cluneal Nerve Entrapment
Keywords: Superior cluneal nerve
nerve entrapment
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: numerical rating scale (NRS)
timeFrame: at baseline (day 0)
measure: numerical rating scale (NRS)
timeFrame: after 45 days
measure: Owestry Disability Index (ODI)
timeFrame: at baseline (day 0)
measure: Owestry Disability Index (ODI)
timeFrame: after 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.