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The Importance of the Superior Cluneal Nerve in Patients With Low Back Pain

Primary Purpose

Low Back Pain, Nerve Entrapment Syndrome, Radiating Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound-guided diagnostic nerve block with lidocaine
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older with mechanical low back pain for more than 3 months
  • Without a history of neurological or psychiatric disease
  • No history of inflammatory disease
  • Patients without a history of trauma in the last 3 months

Exclusion Criteria:

  • Age younger than 18 and over 75
  • Having a history of acute trauma in the last 3 months
  • Presence of inflammatory rheumatic disease (RA, Ankylosing spondylitis, Polymyalgia rheumatica, vasculitides etc.)
  • Patients who have been injected (steroid, hyaluronic acid, etc.) in the last 6 weeks
  • Presence of active infection
  • The use of anticoagulants that may interfere with the injection
  • Presence of bleeding disorder
  • Known allergy to injection agents
  • Presence of uncontrolled diabetes mellitus and/or hypertension
  • Presence of heart failure
  • History of malignancy
  • Having a history of neurological disease
  • Pregnancy, lactation
  • Psychiatric disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    diagnostic superior cluneal nerve block

    Arm Description

    Patients with low back pain will be evaluated by two physicians. The clinical history and physical examination of all patients with low back pain will be taken by the first physician. Patients with a trigger point in the posterior iliac crest will be evaluated by a second physician and diagnostic nerve block will be performed ultrasound-guided with the preliminary diagnosis of superior cluneal nerve entrapment. General Electric LogiqP5 model ultrasound device will be used and lidocaine will be applied between the posterior iliac crest and thoracolumbar fascia, which is viewed under the guidance of ultrasonography, for diagnosis and treatment. Patients who have had a diagnostic injection will be re-evaluated 1 hour later. Patients whose pain is reduced by more than 50% will be diagnosed with superior cluneal nerve entrapment.

    Outcomes

    Primary Outcome Measures

    More than 50% reduction in pain with diagnostic nerve block
    250 patients who applied to the outpatient clinic with low back pain will be examined and patients with posterior iliac crest pain will be given a diagnostic injection under ultrasound guidance with a preliminary diagnosis of superior cluneal nerve entrapment.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    March 22, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05303597
    Brief Title
    The Importance of the Superior Cluneal Nerve in Patients With Low Back Pain
    Official Title
    The Importance of the Superior Cluneal Nerve in Patients With Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    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
    The cluneal nerves are a group of pure sensory nerves that provide direct cutaneous innervation to the buttocks. In recent years, pain syndromes secondary to cluneal nerve pathology ,have been implicated as the cause of chronic pain that both arises directly from the buttocks and is referred from the lower back, pelvic area, or even lower extremity regions . Cluneal syndromes are the causes of neuropathic pain, often underdiagnosed and overlooked, and other anatomical sources are often cited as the cause of pain in the etiology.The cluneal nerve complex includes the superior cluneal nerves (SCN), the middle cluneal nerves (MCN), and the inferior cluneal nerves (ICN). These nerves are susceptible to entrapment neuropathy due to direct or indirect compression and cause different clinical symptoms depending on their location. The superior cluneal nerve(SCN) originates from the T11-L5 nerve roots and has at least 3 branches from medial to lateral; these are the medial, intermediate, and lateral branches. Anatomy studies have shown that the medial branch passes 6-7 cm lateral to the midline on the posterior iliac crest. Nerve branches pass through the osteofibrous tunnel formed by the thoracolumbar fascia and the superior edge of the iliac crest, where they can be trapped. Controversial data exist regarding the osteofibrous tunnel. It may not be present in all cases, and in some cases more than one nerve has been shown to pass through the osteofibrous tunnel. As a result, there are discussions about superior cluneal nerve anatomy and there is not enough information. In patients with superior cluneal nerve entrapment syndrome, low back pain radiates to the upper part of the hip and may cause leg pain that mimics radiculopathy. The diagnosis is clinical. Diagnostic criteria for superior cluneal nerve (SCN) entrapment; Low back pain involving the iliac crest and buttocks, symptoms aggravated by lumbar movement or posture, trigger point over the posterior iliac crest corresponding to the nerve compression zone, patients report numbness and radiating pain in the SCN area (Tinel sign) when the trigger point is compressed, symptom relief by SCN block at the trigger point. Prevalence studies of superior cluneal nerve entrapment syndrome are very few. Maigne et al reported superior cluneal nerve entrapment in 1.6% of 1,800 patients with low back pain. Kuniya et al showed that 14% of 834 patients with low back pain met the criteria for superior cluneal nerve entrapment. Superior cluneal nerve entrapment is not as rare as it is thought to be among the causes of low back pain. In Turkey, there is no study showing the prevalence of the superior cluneal nerve or its importance in patients with low back pain. The aim of this study is to examine the patients who applied to Cerrahpasa Faculty of Medicine, Department of Physical Medicine and Rehabilitation polyclinic with low back pain; To confirm the diagnosis with an ultrasound-guided diagnostic injection test, to determine the importance of superior cluneal nerve entrapment.
    Detailed Description
    Patients with low back pain will be examined by two doctors. The clinical history and physical examination of all patients with low back pain will be taken by the first physician. Patients with a trigger point in the posterior iliac crest will be evaluated by a second physician and diagnostic nerve block will be performed ultrasound-guided with the preliminary diagnosis of superior cluneal nerve entrapment. General Electric LogiqP5 model ultrasound device will be used and lidocaine will be applied between the posterior iliac crest and thoracolumbar fascia, which is viewed under the guidance of ultrasonography, for diagnosis and treatment. Patients who have had a diagnostic injection will be re-evaluated 1 hour later. Patients whose pain is reduced by more than 50% will be diagnosed with superior cluneal nerve entrapment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Nerve Entrapment Syndrome, Radiating Pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    diagnostic superior cluneal nerve block
    Arm Type
    Other
    Arm Description
    Patients with low back pain will be evaluated by two physicians. The clinical history and physical examination of all patients with low back pain will be taken by the first physician. Patients with a trigger point in the posterior iliac crest will be evaluated by a second physician and diagnostic nerve block will be performed ultrasound-guided with the preliminary diagnosis of superior cluneal nerve entrapment. General Electric LogiqP5 model ultrasound device will be used and lidocaine will be applied between the posterior iliac crest and thoracolumbar fascia, which is viewed under the guidance of ultrasonography, for diagnosis and treatment. Patients who have had a diagnostic injection will be re-evaluated 1 hour later. Patients whose pain is reduced by more than 50% will be diagnosed with superior cluneal nerve entrapment.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ultrasound-guided diagnostic nerve block with lidocaine
    Intervention Description
    Patients with a trigger point in the posterior iliac crest will be evaluated by a second physician and diagnostic nerve block will be performed ultrasound-guided with the preliminary diagnosis of superior cluneal nerve entrapment. General Electric LogiqP5 model ultrasound device will be used and lidocaine will be applied between the posterior iliac crest and thoracolumbar fascia, which is viewed under the guidance of ultrasonography, for diagnosis and treatment.
    Primary Outcome Measure Information:
    Title
    More than 50% reduction in pain with diagnostic nerve block
    Description
    250 patients who applied to the outpatient clinic with low back pain will be examined and patients with posterior iliac crest pain will be given a diagnostic injection under ultrasound guidance with a preliminary diagnosis of superior cluneal nerve entrapment.
    Time Frame
    two months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older with mechanical low back pain for more than 3 months Without a history of neurological or psychiatric disease No history of inflammatory disease Patients without a history of trauma in the last 3 months Exclusion Criteria: Age younger than 18 and over 75 Having a history of acute trauma in the last 3 months Presence of inflammatory rheumatic disease (RA, Ankylosing spondylitis, Polymyalgia rheumatica, vasculitides etc.) Patients who have been injected (steroid, hyaluronic acid, etc.) in the last 6 weeks Presence of active infection The use of anticoagulants that may interfere with the injection Presence of bleeding disorder Known allergy to injection agents Presence of uncontrolled diabetes mellitus and/or hypertension Presence of heart failure History of malignancy Having a history of neurological disease Pregnancy, lactation Psychiatric disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    busra sezer kıral
    Phone
    +905548922307
    Email
    bsezer91@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenan Akgun
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Importance of the Superior Cluneal Nerve in Patients With Low Back Pain

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