<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/NCT04421573</url>
  </required_header>
  <id_info>
    <org_study_id>DextrosePTSD1</org_study_id>
    <nct_id>NCT04421573</nct_id>
  </id_info>
  <brief_title>Cervical Plexus Hydrodissection With D5W for PTSD</brief_title>
  <official_title>Cervical Plexus Hydrodissection With D5W for PTSD Versus Delayed Treatment/Usual Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Dean Reeves Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Francois Louw, M.D</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jannice Bowler, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanley Lam, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr. Dean Reeves Clinic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      PTSD is a chronic mental health condition that drastically reduces an individual's quality of&#xD;
      life Dextrose injection with a small needle has been used for chronic pain patients and&#xD;
      observational results have shown it to be effective in reducing anxiety, brain fog, and&#xD;
      depression in patients with PTSD. This randomized trial will compare dextrose injection with&#xD;
      a delayed/usual treatment control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PTSD is a well-recognized debilitating mental health condition associated with previous&#xD;
      trauma exposure. It is part of the DSM-5 Trauma and Stressor related disorders category.&#xD;
      Treatments for PTSD normally involve a multi-disciplinary approach. First-line treatments&#xD;
      include psychotherapy and serotonergic reuptake inhibitors. Many patients fail&#xD;
      pharmacotherapy and psychotherapy. Unilateral stellate ganglion block performed favorably for&#xD;
      treatment of PTSD in a recent RCT, based upon an expectation that the cervical sympathetic&#xD;
      system is neuropathically upregulated in PTSD. However, inclusion of lidocaine requires the&#xD;
      presence of an emergency response team due to the potential for inadvertent intravascular&#xD;
      injection with generalized seizures or hypotension, and inadvertent laryngeal or phrenic&#xD;
      nerve block. Perineural injection of peripheral nerves, plexi, or sympathetic ganglia with&#xD;
      dextrose 5% in water (D5W), has performed well empirically in the treatment of post-traumatic&#xD;
      stress disorder. No lidocaine is utilized, which allows for avoidance of lidocaine toxicity&#xD;
      risk, or any risk of nerve block. Because of that, bilateral procedures are feasible, and&#xD;
      these procedures can be performed in any outpatient office with ultrasound availability, as&#xD;
      emergency team backup is not necessary, making the procedure readily accessible. A cumulative&#xD;
      benefit has been observed, as well. The effects of BHDCP with D5W as a stand-alone treatment&#xD;
      for PTSD has not been formally evaluated. The primary objective of this study is to determine&#xD;
      the short term effects of BHDCP with D5W on anxiety and longer-term effects on the Post&#xD;
      Traumatic Stress Disorder Check List for Civilians (PCL-C), The primary hypotheses are that&#xD;
      BHDCP with D5W will outperform a waiting/usual care group in both anxiety reduction and PCL-5&#xD;
      score improvement. A study size of 24 is planned, based on power analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 10, 2023</start_date>
  <completion_date type="Anticipated">October 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCL-C Score</measure>
    <time_frame>3 months</time_frame>
    <description>Measurement of response to very stressful experiences in the last month. Range from 0 to 80. An improvement is a reduction in the PCL-5 score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression scale</measure>
    <time_frame>3 months</time_frame>
    <description>Measurement of symptoms of anxiety and depression. Range from 0 to 21. An improvement is a reduction in the HADS score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)</measure>
    <time_frame>3 months</time_frame>
    <description>Anchors include &quot;0 = no satisfaction&quot; and &quot;10 = complete satisfaction&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQOL-5D-5L + C scale</measure>
    <time_frame>3 months</time_frame>
    <description>Measurement of general quality of life. Each question has a range from 1 to 5. An improvement is a reduction in score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>BCPHD-D5W with usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral cervical plexus hydrodissection with D5W (BCPHD-D5W) at 0, 2, 4, and 8 weeks.&#xD;
All helpful treatment methods already underway are continued. Other new treatment methods are discouraged.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting period with usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All helpful treatment methods already underway are continued. Other new treatment methods are discouraged.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BCPHD with D5W</intervention_name>
    <description>D5W is injected under the investing fascia of the sternocleidomastoid muscle (SCM) using ultrasound guidance in order to infiltrate the space containing the cervical plexus. This is performed on both sides.</description>
    <arm_group_label>BCPHD-D5W with usual care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Waiting period with usual care</intervention_name>
    <description>Same as previous group description</description>
    <arm_group_label>Waiting period with usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not involved in another study of PTSD treatment&#xD;
&#xD;
          -  Reliable transportation&#xD;
&#xD;
          -  Comfortable with computers&#xD;
&#xD;
          -  Tried 2 or more medications for treatment of PTSD symptoms&#xD;
&#xD;
          -  Tried 2 or more non-medication treatments for PTSD symptom&#xD;
&#xD;
          -  No known life-threatening illness&#xD;
&#xD;
          -  Not taking daily narcotics&#xD;
&#xD;
          -  Not having 3or more alcoholic drinks on an average day&#xD;
&#xD;
          -  No active suicidal plans&#xD;
&#xD;
          -  No major surgery plans&#xD;
&#xD;
          -  No major life stress that might interfere with completing study&#xD;
&#xD;
          -  Symptoms for more than 1 year&#xD;
&#xD;
          -  Not planning to move for next 18 months.&#xD;
&#xD;
          -  Living within an hour of Kelowna or Victoria, British Columbia, or Hong Kong&#xD;
&#xD;
          -  Wiling to provide 2 email and 2 phone contact methods&#xD;
&#xD;
          -  Willing to answer questions on multiple occasions over the course of a year.&#xD;
&#xD;
          -  Willing to be assigned to 3 months of usual care treatment&#xD;
&#xD;
          -  No diagnosis of schizophrenia, Borderline Personality Disorder, or Bipolar Disorder.&#xD;
&#xD;
          -  No severe needle phobia&#xD;
&#xD;
          -  Chronic pain ≤ 5/10&#xD;
&#xD;
          -  PCL-C score ≥ 50&#xD;
&#xD;
        Exclusion Criteria: None separate from inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth D Reeves, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dr. Dean Reeves Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kenneth D Reeves, M.D.</last_name>
    <phone>9133621600</phone>
    <email>DeanReevesMD@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Clare R Solso, R.N.</last_name>
    <phone>4058197777</phone>
    <email>cereeves2002@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Entheomed Clinic</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y6T8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francois Louw, M.D.</last_name>
      <phone>2364206854</phone>
      <email>doclouw@mail.ubc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Nina Gregoire</last_name>
      <email>nina44@student.ubc.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Bowler Medical Clinic</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jannice Bowler, MB:ChB</last_name>
      <phone>7884060077</phone>
      <email>jannicebowler@icloud.com</email>
    </contact>
    <contact_backup>
      <last_name>Nina Gregoire</last_name>
      <email>nina44@student.ubc.ca</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Stanley H.K. Lam Clinic</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stanley Lam, M.D.</last_name>
      <email>DrLamKH@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Nina Gregoire</last_name>
      <email>nina44@student.ubc.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>China</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474. Erratum In: JAMA Psychiatry. 2020 Jan 2;: JAMA Psychiatry. 2020 Sep 1;77(9):982.</citation>
    <PMID>31693083</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Dean Reeves Clinic</investigator_affiliation>
    <investigator_full_name>Dr. Dean Reeves</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dextrose</keyword>
  <keyword>Hydrodissection</keyword>
  <keyword>Cervical Plexus</keyword>
  <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/NCT04421573
org study id: DextrosePTSD1
nct id: NCT04421573
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
PTSD is a chronic mental health condition that drastically reduces an individual's quality of
      life Dextrose injection with a small needle has been used for chronic pain patients and
      observational results have shown it to be effective in reducing anxiety, brain fog, and
      depression in patients with PTSD. This randomized trial will compare dextrose injection with
      a delayed/usual treatment control.
PTSD is a well-recognized debilitating mental health condition associated with previous
      trauma exposure. It is part of the DSM-5 Trauma and Stressor related disorders category.
      Treatments for PTSD normally involve a multi-disciplinary approach. First-line treatments
      include psychotherapy and serotonergic reuptake inhibitors. Many patients fail
      pharmacotherapy and psychotherapy. Unilateral stellate ganglion block performed favorably for
      treatment of PTSD in a recent RCT, based upon an expectation that the cervical sympathetic
      system is neuropathically upregulated in PTSD. However, inclusion of lidocaine requires the
      presence of an emergency response team due to the potential for inadvertent intravascular
      injection with generalized seizures or hypotension, and inadvertent laryngeal or phrenic
      nerve block. Perineural injection of peripheral nerves, plexi, or sympathetic ganglia with
      dextrose 5% in water (D5W), has performed well empirically in the treatment of post-traumatic
      stress disorder. No lidocaine is utilized, which allows for avoidance of lidocaine toxicity
      risk, or any risk of nerve block. Because of that, bilateral procedures are feasible, and
      these procedures can be performed in any outpatient office with ultrasound availability, as
      emergency team backup is not necessary, making the procedure readily accessible. A cumulative
      benefit has been observed, as well. The effects of BHDCP with D5W as a stand-alone treatment
      for PTSD has not been formally evaluated. The primary objective of this study is to determine
      the short term effects of BHDCP with D5W on anxiety and longer-term effects on the Post
      Traumatic Stress Disorder Check List for Civilians (PCL-C), The primary hypotheses are that
      BHDCP with D5W will outperform a waiting/usual care group in both anxiety reduction and PCL-5
      score improvement. A study size of 24 is planned, based on power analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized open-label crossover study comparing BHDCP with D5W versus a waiting period in which usual care is allowed.
primary purpose: Treatment
masking: None (Open Label)
measure: PCL-C Score
time frame: 3 months
description: Measurement of response to very stressful experiences in the last month. Range from 0 to 80. An improvement is a reduction in the PCL-5 score.
measure: Hospital Anxiety and Depression scale
time frame: 3 months
description: Measurement of symptoms of anxiety and depression. Range from 0 to 21. An improvement is a reduction in the HADS score.
measure: Satisfaction with treatment outcome as measured by a 0-10 Numerical Rating Scale (NRS)
time frame: 3 months
description: Anchors include "0 = no satisfaction" and "10 = complete satisfaction"
measure: EuroQOL-5D-5L + C scale
time frame: 3 months
description: Measurement of general quality of life. Each question has a range from 1 to 5. An improvement is a reduction in score.
arm group label: BCPHD-D5W with usual care
arm group type: Experimental
description: Bilateral cervical plexus hydrodissection with D5W (BCPHD-D5W) at 0, 2, 4, and 8 weeks.
All helpful treatment methods already underway are continued. Other new treatment methods are discouraged.
arm group label: Waiting period with usual care
arm group type: Active Comparator
description: All helpful treatment methods already underway are continued. Other new treatment methods are discouraged.
intervention type: Procedure
intervention name: BCPHD with D5W
description: D5W is injected under the investing fascia of the sternocleidomastoid muscle (SCM) using ultrasound guidance in order to infiltrate the space containing the cervical plexus. This is performed on both sides.
arm group label: BCPHD-D5W with usual care
intervention type: Procedure
intervention name: Waiting period with usual care
description: Same as previous group description
arm group label: Waiting period with usual care
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth D Reeves, M.D.
role: Principal Investigator
affiliation: Dr. Dean Reeves Clinic
last name: Kenneth D Reeves, M.D.
phone: 9133621600
email: DeanReevesMD@gmail.com
last name: Clare R Solso, R.N.
phone: 4058197777
email: cereeves2002@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
country: China
country: United States
citation: Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474. Erratum In: JAMA Psychiatry. 2020 Jan 2;: JAMA Psychiatry. 2020 Sep 1;77(9):982.
PMID: 31693083
responsible party type: Principal Investigator
investigator affiliation: Dr. Dean Reeves Clinic
investigator full name: Dr. Dean Reeves
investigator title: Principal Investigator
sharing ipd: No