<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/NCT04499911</url>
  </required_header>
  <id_info>
    <org_study_id>0303901</org_study_id>
    <nct_id>NCT04499911</nct_id>
  </id_info>
  <brief_title>Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica</brief_title>
  <official_title>Efficacy of Neural Prolotherapy in Treatment of Meralgia Paresthetica</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Meralgia paresthetica is an entrapment neuropathy of the lateral femoral cutaneous nerve. Its&#xD;
      main manifestation is neuropathic pain on the lateral aspect of the thigh. Neural&#xD;
      prolotherapy has shown improvement and relieve of neuropathic pain.&#xD;
&#xD;
      The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous&#xD;
      perineural injection of dextrose 5% solution) on reliving pain and improvement of function&#xD;
      and quality of life in patients with meralgia paresthetica.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Meralgia paresthetica is a mononeuropathy of the lateral femoral cutaneous nerve (i.e.&#xD;
      lateral cutaneous nerve of the thigh). It is known as the lateral cutaneous nerve of the&#xD;
      thigh neuralgia. It is due to a lot of etiologies. It is characterized by neuropathic pain,&#xD;
      tingling, paresthesia and numbness in the anterolateral aspect of the thigh. The symptoms may&#xD;
      be provoked or worsened by prolonged standing and walking. Sitting may alleviate the pain&#xD;
      because there is reduction of the tension over the nerve, The treatment of meralgia&#xD;
      paresthetica is directed towards the improvement of the symptoms which is mainly pain with&#xD;
      subsequent improvement of function and quality of life, as well as, treatment of the&#xD;
      etiology. The treatment includes conservative and surgical treatment. Conservative treatment&#xD;
      consists of non-pharmacologic treatment and pharmacologic treatment. Surgical treatment takes&#xD;
      place in case of failure of the conservative treatment. Surgical options consist of&#xD;
      neurolysis and neurectomy.&#xD;
&#xD;
      Neural prolotherapy was reported to improve and relieve of neuropathic pain including that of&#xD;
      meralgia paresthetica. Neural prolotherapy is the subcutaneous perineural injection of&#xD;
      isotonic dextrose (5%) solution especially at the points of fascial penetration of the&#xD;
      sensory nerve. It is the site where the sensory nerve reaches the subcutaneous plane. There&#xD;
      are scanty studies assessed this issue.&#xD;
&#xD;
      The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous&#xD;
      perineural injection of dextrose 5% solution) on reliving pain and improvement of function&#xD;
      and quality of life in patients with meralgia paresthetica.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia) by using visual analogue scale were evaluated collectively by using VAS. It is a 10-cm horizontal scale) which range from 0 (no meralgia paresthetica symptoms), to 10 (severe intolerable symptoms).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient assessment of meralgia paresthetica pain</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patient assessment of meralgia paresthetica pain was evaluated by using visual analogue scale. It is a 10-cm horizontal scale which range from 0 (no pain), to 10 (severe intolerable pain).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Meralgia Paresthetica</condition>
  <arm_group>
    <arm_group_label>Neural prolotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neural prolotherapy using isotonic dextrose 5% in water solution (about 5 ml). The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isotonic dextrose 5% in water solution</intervention_name>
    <description>The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.</description>
    <arm_group_label>Neural prolotherapy</arm_group_label>
    <other_name>Subcutaneous nerual prolotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients had clinical evidence of meralgia paresthetica which was based on the&#xD;
             following: (i) the presence of pain, paraesthesia and numbness over the anterior and&#xD;
             lateral aspect of the thigh; (ii) exacerbation of these symptoms on walking, standing&#xD;
             and hip extension; and (iii) meralgia paresthetica was confirmed&#xD;
             electrophysiologically by nerve conduction study with or without somatosensory evoked&#xD;
             potentials.&#xD;
&#xD;
          -  The symptoms needed to be present for at least three months.&#xD;
&#xD;
          -  The patients should be unresponsive to conservative treatment. The conservative&#xD;
             treatment included lifestyle modification including weight reduction, activity&#xD;
             modification (avoid the use of seat belts) and avoidance of tight underwear (tight&#xD;
             garments such as jeans, uniforms); non-steroidal anti-inflammatory drugs and&#xD;
             anticonvulsants for neuropathic pain; and physiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus.&#xD;
&#xD;
          -  Endocrine disorders.&#xD;
&#xD;
          -  Metabolic disorders.&#xD;
&#xD;
          -  Systemic rheumatologic disorders.&#xD;
&#xD;
          -  Neurological disorders including peripheral neuropathy, lumbar radiculopathy and&#xD;
             lumbar plexopathy.&#xD;
&#xD;
          -  Coagulopathy.&#xD;
&#xD;
          -  Anticoagulant treatment.&#xD;
&#xD;
          -  Current skin or soft tissue infection at or near the site of injection.&#xD;
&#xD;
          -  Prior local injection of corticosteroid in the past year for meralgia paresthetica.&#xD;
&#xD;
          -  Prior neural prolotherapy in the past year for meralgia paresthetica.&#xD;
&#xD;
          -  Prior surgery in the affected thigh region.&#xD;
&#xD;
          -  Patients presented with a systemic active inflammatory condition or infection.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patients refused to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel K Saba, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21131</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Emmanuel Kamal Aziz Saba</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Meralgia paresthetica</keyword>
  <keyword>Neural Prolotherapy</keyword>
  <keyword>lateral femoral cutaneous nerve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femoral Neuropathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
  </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/NCT04499911
org study id: 0303901
nct id: NCT04499911
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Meralgia paresthetica is an entrapment neuropathy of the lateral femoral cutaneous nerve. Its
      main manifestation is neuropathic pain on the lateral aspect of the thigh. Neural
      prolotherapy has shown improvement and relieve of neuropathic pain.

      The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous
      perineural injection of dextrose 5% solution) on reliving pain and improvement of function
      and quality of life in patients with meralgia paresthetica.
Meralgia paresthetica is a mononeuropathy of the lateral femoral cutaneous nerve (i.e.
      lateral cutaneous nerve of the thigh). It is known as the lateral cutaneous nerve of the
      thigh neuralgia. It is due to a lot of etiologies. It is characterized by neuropathic pain,
      tingling, paresthesia and numbness in the anterolateral aspect of the thigh. The symptoms may
      be provoked or worsened by prolonged standing and walking. Sitting may alleviate the pain
      because there is reduction of the tension over the nerve, The treatment of meralgia
      paresthetica is directed towards the improvement of the symptoms which is mainly pain with
      subsequent improvement of function and quality of life, as well as, treatment of the
      etiology. The treatment includes conservative and surgical treatment. Conservative treatment
      consists of non-pharmacologic treatment and pharmacologic treatment. Surgical treatment takes
      place in case of failure of the conservative treatment. Surgical options consist of
      neurolysis and neurectomy.

      Neural prolotherapy was reported to improve and relieve of neuropathic pain including that of
      meralgia paresthetica. Neural prolotherapy is the subcutaneous perineural injection of
      isotonic dextrose (5%) solution especially at the points of fascial penetration of the
      sensory nerve. It is the site where the sensory nerve reaches the subcutaneous plane. There
      are scanty studies assessed this issue.

      The aim of the current study was to assess the efficacy of neural prolotherapy (subcutaneous
      perineural injection of dextrose 5% solution) on reliving pain and improvement of function
      and quality of life in patients with meralgia paresthetica.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia)
time frame: 4 weeks
description: Patient assessment of the overall symptoms of meralgia paresthetica (pain/ burning sensation/paraesthesia) by using visual analogue scale were evaluated collectively by using VAS. It is a 10-cm horizontal scale) which range from 0 (no meralgia paresthetica symptoms), to 10 (severe intolerable symptoms).
measure: Patient assessment of meralgia paresthetica pain
time frame: 4 weeks
description: Patient assessment of meralgia paresthetica pain was evaluated by using visual analogue scale. It is a 10-cm horizontal scale which range from 0 (no pain), to 10 (severe intolerable pain).
arm group label: Neural prolotherapy
arm group type: Experimental
description: Neural prolotherapy using isotonic dextrose 5% in water solution (about 5 ml). The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.
intervention type: Drug
intervention name: Isotonic dextrose 5% in water solution
description: The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.
arm group label: Neural prolotherapy
other name: Subcutaneous nerual prolotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Emmanuel K Saba, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Alexandria University, Alexandria Governorate, Egypt.
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Emmanuel Kamal Aziz Saba
investigator title: Assistant professor
mesh term: Femoral Neuropathy
sharing ipd: No
ipd description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.