<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04478344</url>
  </required_header>
  <id_info>
    <org_study_id>201912037RINC</org_study_id>
    <nct_id>NCT04478344</nct_id>
  </id_info>
  <brief_title>Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment</brief_title>
  <official_title>Precise Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain (LBP) is a common complaint in the clinical setting. Among all the differential&#xD;
      diagnosis for LBP, superior cluneal nerve (SCN) entrapment is the commonly omitted one. The&#xD;
      superior cluneal nerve is the terminal branch of the lateral branches of the posterior rami&#xD;
      of the L1-L3 spinal nerves, which passes through the osseous tunnel interposed between the&#xD;
      thoracolumbar fascia and iliac crest. This nerve can be entrapped due to poor posture, trauma&#xD;
      or stretching of the surrounding thoracolumbar fascia and osseous membrane. The cardinal&#xD;
      symptom of the superior cluneal nerve entrapment is buttock pain. Sometimes the pain may&#xD;
      radiate to the lower limb, which mimics sciatica, and makes the diagnosis difficult. Early&#xD;
      diagnosis and treatment of SCN entrapment is crucial, which can facilitate the improvement of&#xD;
      health related quality of life and decrement the socioeconomic loss due to disability.&#xD;
&#xD;
      The study aims is (1) to scan the SCN and thoracolumbar fascia by ultrasound in patients with&#xD;
      LBP and normal subjects. The transcutaneous electrical stimulation will be used to confirm&#xD;
      the location of SCN by asking the subject to depict the sensory distribution after&#xD;
      stimulation; (2) to analyze the related factors of LBP with SCN entrapment, which may help in&#xD;
      setting up the diagnostic criteria of SCN entrapment; (3) to analyze the therapeutic effect&#xD;
      of perineural injection to SCN in SCN entrapment, and to find the factors that related&#xD;
      responsiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Superior cluneal nerve (SCN) entrapment is the commonly omitted diagnosis in chronic low back&#xD;
      pain. The superior cluneal nerve is the terminal branch of the lateral branches of the&#xD;
      posterior rami of the L1-L3 spinal nerves, which passes through the osseous tunnel interposed&#xD;
      between the thoracolumbar fascia and iliac crest. This nerve can be entrapped due to poor&#xD;
      posture, trauma or stretching of the surrounding thoracolumbar fascia and osseous membrane.&#xD;
      The cardinal symptom of the superior cluneal nerve entrapment is buttock pain. Sometimes the&#xD;
      pain may radiate to the lower limb, which mimics sciatica, and makes the diagnosis difficult.&#xD;
      Early diagnosis and treatment of SCN entrapment is crucial, which can facilitate the&#xD;
      improvement of health related quality of life and decrement the socioeconomic loss due to&#xD;
      disability.&#xD;
&#xD;
      Material and methods:&#xD;
&#xD;
      Participants: Adult patients (&gt;20 year old) with low back/buttock pain. The pain consists&#xD;
      area of iliac crest.&#xD;
&#xD;
      Control : healthy adult subjects (&gt;20 year old) without low back&#xD;
&#xD;
      Exclusion criteria: non-mechanical low back pain, referred low back pain (tumor, infection,&#xD;
      inflammatory arthritis, Scheuermann disease,Paget disease, herpetic neuralgia), trauma, acute&#xD;
      compression fracture, acute herniated disc, underwent nerve block within 3 months.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      (1) To scan the SCN and thoracolumbar fascia by high-resolution ultrasound in patients with&#xD;
      LBP and normal subjects. The transcutaneous electrical stimulation will be used to confirm&#xD;
      the location of SCN by asking the subject to depict the sensory distribution after&#xD;
      stimulation; (2) to analyze the related factors of LBP with SCN entrapment, which may help in&#xD;
      setting up the diagnostic criteria of SCN entrapment; (3) to analyze the therapeutic effect&#xD;
      of perineural injection to SCN in SCN entrapment, and to find the factors that related&#xD;
      responsiveness.&#xD;
&#xD;
      Detail of the intervention&#xD;
&#xD;
        1. High-resolution ultrasound evaluation of buttock region to recognize the superior&#xD;
           cluneal nerve in patients with SCN entrapment and healthy control. The transcutaneous&#xD;
           electrical stimulation will be assisted device for confirming the diagnosis by&#xD;
           subjective response of patients.&#xD;
&#xD;
        2. Collecting the LBP-related information, including physical examination results ((SLRT,&#xD;
           Extension in one-leg standing, Gaeslen's test, Yeoman's test, compression test,&#xD;
           distraction test, FABER test and ROM), lumbosacral and pelvic X-ray. Compare the related&#xD;
           information with sonography results.&#xD;
&#xD;
        3. Intervention: single arm experiment design. Ultrasound guided perineural injection with&#xD;
           1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9 % normal saline to the site&#xD;
           where SCN being entrapment, to evaluate the clinical efficacy of perineural injection to&#xD;
           SCN entrapment.&#xD;
&#xD;
      Outcome measurement:&#xD;
&#xD;
      Primary outcome :&#xD;
&#xD;
        1. Visual analogue scale&#xD;
&#xD;
        2. Modified version of the Oswestry Disability Questionnaire used in the AAOS lumbar&#xD;
           cluster&#xD;
&#xD;
        3. Short-Form-36 (SF-36)&#xD;
&#xD;
      at baseline one month and three months after injection&#xD;
&#xD;
      Secondary outcome:&#xD;
&#xD;
        1. Sonography (gray-scale/elastography) at baseline, one month and three months after&#xD;
           injection&#xD;
&#xD;
        2. Pressure pain threshold&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Continuous variables&#xD;
&#xD;
        1. Student's t test: fit assumption of normal distribution&#xD;
&#xD;
        2. Mann-Whitney test: does not fit the assumption of normal distribution Categorical&#xD;
           variables&#xD;
&#xD;
      1. Chi-square test 2. Fisher exact test: sparse data&#xD;
&#xD;
      Multivariate analysis:&#xD;
&#xD;
      Generalized Estimating Equations&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Questionnaire</measure>
    <time_frame>Change of the score between one month and baseline, and change of the score between three months and baseline</time_frame>
    <description>Oswestry Disability Questionnaire, A 10 item questionnaire, score ranges from 0 to 100, and a higher score indicates worse function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form-36 Questionnaire</measure>
    <time_frame>Change of the score between one month and baseline, and change of the score between three month and baseline</time_frame>
    <description>Reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social func-tion, emotional role, and mental health. The categories of physical role and emotional role reflect performance at the activity and participation levels. The score will be transformed between 0 to 100. The higher score means better health condition in each domain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>Change of the score between one month and baseline, and change of the score between three months and baseline</time_frame>
    <description>The pain scale to evaluate pain, from 0 to 10. The lower means less pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasound evaluation of SCN (Grey scale)</measure>
    <time_frame>Measurement change between one month and baseline and between three months and baseline</time_frame>
    <description>Measurement of cross sectional area (square millimeters) and record image</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Nerve Entrapment Syndrome</condition>
  <arm_group>
    <arm_group_label>Ultrasound guided hydrodissection to superior cluneal nerve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with superior cluneal nerve enttrappment given by ultrasound guided perineural injection with a mixture of 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9% normal saline to superior cluneal nerve of affected side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients without superior cluneal nerve entrappment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound guided hydrodissection of superior cluneal nerve</intervention_name>
    <description>Intervention procedure: hydrodissection to the superior cluneal nerve entrapment; Device for guidance of injection: high-resolution ultrasound ; Drug for injection: a mixture of 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9% normal saline</description>
    <arm_group_label>Ultrasound guided hydrodissection to superior cluneal nerve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants:&#xD;
&#xD;
          -  Adult patients (&gt;20 year old) with low back/buttock pain.&#xD;
&#xD;
          -  The pain consists area of iliac crest Control : healthy adult subjects (&gt;20 year old)&#xD;
             without low back&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  non-mechanical low back pain&#xD;
&#xD;
          -  referred low back pain (tumor, infection, inflammatory arthritis, Scheuermann&#xD;
             disease,Paget disease, herpetic neuralgia)&#xD;
&#xD;
          -  trauma&#xD;
&#xD;
          -  acute compression fracture&#xD;
&#xD;
          -  acute herniated disc&#xD;
&#xD;
          -  underwent lumbar region nerve block within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ke-Vin Chang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital, Bei-Hu Branch</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ke-Vin Chang, MD,PhD</last_name>
    <phone>+886-23717101</phone>
    <phone_ext>5309</phone_ext>
    <email>kvchang011@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital, Bei-Hu Branch</name>
      <address>
        <city>Taipei</city>
        <state>Wanhua District</state>
        <zip>108</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>kvchang011@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 25, 2023</last_update_submitted>
  <last_update_submitted_qc>June 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasonography</keyword>
  <keyword>Superior cluneal nerve</keyword>
  <keyword>Nerve entrapment</keyword>
  <keyword>Prediction</keyword>
  <keyword>Ultrasound-guided injection</keyword>
  <keyword>Hydrodissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nerve Compression Syndromes</mesh_term>
    <mesh_term>Charcot-Marie-Tooth Disease</mesh_term>
    <mesh_term>Hereditary Sensory and Motor Neuropathy</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04478344
org study id: 201912037RINC
nct id: NCT04478344
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Low back pain (LBP) is a common complaint in the clinical setting. Among all the differential
      diagnosis for LBP, superior cluneal nerve (SCN) entrapment is the commonly omitted one. The
      superior cluneal nerve is the terminal branch of the lateral branches of the posterior rami
      of the L1-L3 spinal nerves, which passes through the osseous tunnel interposed between the
      thoracolumbar fascia and iliac crest. This nerve can be entrapped due to poor posture, trauma
      or stretching of the surrounding thoracolumbar fascia and osseous membrane. The cardinal
      symptom of the superior cluneal nerve entrapment is buttock pain. Sometimes the pain may
      radiate to the lower limb, which mimics sciatica, and makes the diagnosis difficult. Early
      diagnosis and treatment of SCN entrapment is crucial, which can facilitate the improvement of
      health related quality of life and decrement the socioeconomic loss due to disability.

      The study aims is (1) to scan the SCN and thoracolumbar fascia by ultrasound in patients with
      LBP and normal subjects. The transcutaneous electrical stimulation will be used to confirm
      the location of SCN by asking the subject to depict the sensory distribution after
      stimulation; (2) to analyze the related factors of LBP with SCN entrapment, which may help in
      setting up the diagnostic criteria of SCN entrapment; (3) to analyze the therapeutic effect
      of perineural injection to SCN in SCN entrapment, and to find the factors that related
      responsiveness.
Introduction:

      Superior cluneal nerve (SCN) entrapment is the commonly omitted diagnosis in chronic low back
      pain. The superior cluneal nerve is the terminal branch of the lateral branches of the
      posterior rami of the L1-L3 spinal nerves, which passes through the osseous tunnel interposed
      between the thoracolumbar fascia and iliac crest. This nerve can be entrapped due to poor
      posture, trauma or stretching of the surrounding thoracolumbar fascia and osseous membrane.
      The cardinal symptom of the superior cluneal nerve entrapment is buttock pain. Sometimes the
      pain may radiate to the lower limb, which mimics sciatica, and makes the diagnosis difficult.
      Early diagnosis and treatment of SCN entrapment is crucial, which can facilitate the
      improvement of health related quality of life and decrement the socioeconomic loss due to
      disability.

      Material and methods:

      Participants: Adult patients (>20 year old) with low back/buttock pain. The pain consists
      area of iliac crest.

      Control : healthy adult subjects (>20 year old) without low back

      Exclusion criteria: non-mechanical low back pain, referred low back pain (tumor, infection,
      inflammatory arthritis, Scheuermann disease,Paget disease, herpetic neuralgia), trauma, acute
      compression fracture, acute herniated disc, underwent nerve block within 3 months.

      Study design:

      (1) To scan the SCN and thoracolumbar fascia by high-resolution ultrasound in patients with
      LBP and normal subjects. The transcutaneous electrical stimulation will be used to confirm
      the location of SCN by asking the subject to depict the sensory distribution after
      stimulation; (2) to analyze the related factors of LBP with SCN entrapment, which may help in
      setting up the diagnostic criteria of SCN entrapment; (3) to analyze the therapeutic effect
      of perineural injection to SCN in SCN entrapment, and to find the factors that related
      responsiveness.

      Detail of the intervention

        1. High-resolution ultrasound evaluation of buttock region to recognize the superior
           cluneal nerve in patients with SCN entrapment and healthy control. The transcutaneous
           electrical stimulation will be assisted device for confirming the diagnosis by
           subjective response of patients.

        2. Collecting the LBP-related information, including physical examination results ((SLRT,
           Extension in one-leg standing, Gaeslen's test, Yeoman's test, compression test,
           distraction test, FABER test and ROM), lumbosacral and pelvic X-ray. Compare the related
           information with sonography results.

        3. Intervention: single arm experiment design. Ultrasound guided perineural injection with
           1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9 % normal saline to the site
           where SCN being entrapment, to evaluate the clinical efficacy of perineural injection to
           SCN entrapment.

      Outcome measurement:

      Primary outcome :

        1. Visual analogue scale

        2. Modified version of the Oswestry Disability Questionnaire used in the AAOS lumbar
           cluster

        3. Short-Form-36 (SF-36)

      at baseline one month and three months after injection

      Secondary outcome:

        1. Sonography (gray-scale/elastography) at baseline, one month and three months after
           injection

        2. Pressure pain threshold

      Statistical analysis:

      Continuous variables

        1. Student's t test: fit assumption of normal distribution

        2. Mann-Whitney test: does not fit the assumption of normal distribution Categorical
           variables

      1. Chi-square test 2. Fisher exact test: sparse data

      Multivariate analysis:

      Generalized Estimating Equations
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oswestry Disability Questionnaire
time frame: Change of the score between one month and baseline, and change of the score between three months and baseline
description: Oswestry Disability Questionnaire, A 10 item questionnaire, score ranges from 0 to 100, and a higher score indicates worse function.
measure: Short Form-36 Questionnaire
time frame: Change of the score between one month and baseline, and change of the score between three month and baseline
description: Reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social func-tion, emotional role, and mental health. The categories of physical role and emotional role reflect performance at the activity and participation levels. The score will be transformed between 0 to 100. The higher score means better health condition in each domain.
measure: Visual analogue scale
time frame: Change of the score between one month and baseline, and change of the score between three months and baseline
description: The pain scale to evaluate pain, from 0 to 10. The lower means less pain.
measure: Ultrasound evaluation of SCN (Grey scale)
time frame: Measurement change between one month and baseline and between three months and baseline
description: Measurement of cross sectional area (square millimeters) and record image
arm group label: Ultrasound guided hydrodissection to superior cluneal nerve
arm group type: Experimental
description: Patients with superior cluneal nerve enttrappment given by ultrasound guided perineural injection with a mixture of 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9% normal saline to superior cluneal nerve of affected side.
arm group label: Control arm
arm group type: No Intervention
description: Patients without superior cluneal nerve entrappment
intervention type: Other
intervention name: Ultrasound guided hydrodissection of superior cluneal nerve
description: Intervention procedure: hydrodissection to the superior cluneal nerve entrapment; Device for guidance of injection: high-resolution ultrasound ; Drug for injection: a mixture of 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9% normal saline
arm group label: Ultrasound guided hydrodissection to superior cluneal nerve
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ke-Vin Chang, MD,PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital, Bei-Hu Branch
last name: Ke-Vin Chang, MD,PhD
phone: +886-23717101
phone ext: 5309
email: kvchang011@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Nerve Compression Syndromes
mesh term: Charcot-Marie-Tooth Disease
mesh term: Hereditary Sensory and Motor Neuropathy
mesh term: Low Back Pain
sharing ipd: No