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

Primary Purpose

Superior Cluneal Nerve Entrapment

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
injection
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superior Cluneal Nerve Entrapment focused on measuring Superior cluneal nerve, nerve entrapment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT06059612
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superior Cluneal Nerve Entrapment
Keywords
Superior cluneal nerve, nerve entrapment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Superior cluneal nerve entrapment (SCN) will be treated with local steroid injection
Intervention Type
Procedure
Intervention Name(s)
injection
Intervention Description
steroid injection into superior cluneal nerve
Primary Outcome Measure Information:
Title
numerical rating scale (NRS)
Description
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
Time Frame
at baseline (day 0)
Title
numerical rating scale (NRS)
Description
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
Time Frame
after 45 days
Title
Owestry Disability Index (ODI)
Description
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.
Time Frame
at baseline (day 0)
Title
Owestry Disability Index (ODI)
Description
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.
Time Frame
after 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Boriani, MD
Phone
+390516366233
Email
luca.boriani@ior.it
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruna Maccaferri
Phone
+39-051636163
Email
bruna.maccaferri@ior.it
First Name & Middle Initial & Last Name & Degree
Alessandro Gasbarrini, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25551470
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.
Results Reference
result
PubMed Identifier
27669049
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.
Results Reference
result
PubMed Identifier
27008294
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.
Results Reference
result

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

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