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

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Recruiting

CT.gov ID

NCT06059612

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Superior Cluneal Nerve Entrapment	Procedure: injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jan 20, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

numerical rating scale (NRS) [at baseline (day 0)]
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
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) [at baseline (day 0)]
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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