<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/NCT02256371</url>
  </required_header>
  <id_info>
    <org_study_id>P130604</org_study_id>
    <nct_id>NCT02256371</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain</brief_title>
  <acronym>PSYCNEP</acronym>
  <official_title>Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized double-blind controlled two centers study. The primary objective of this study&#xD;
      will be to show a superiority of hypnosis over relaxation on pain intensity in patients with&#xD;
      neuropathic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The secondary objectives of this study are:&#xD;
&#xD;
        -  to show a superiority of hypnosis and relaxation over control group on neuropathic pain.&#xD;
&#xD;
        -  to show a lasting effect of treatment on neuropathic pain one week after the end of&#xD;
           treatment.&#xD;
&#xD;
        -  to evaluate the clinical predictors of response to hypnosis (nature of neuropathic&#xD;
           symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping&#xD;
           strategies, emotional regulation, response to the first session, positive or negative&#xD;
           emotional reaction at the end of hypnosis sessions).&#xD;
&#xD;
        -  to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of&#xD;
           treatment).&#xD;
&#xD;
        -  to evaluate the effect of hypnosis on emotional processes.&#xD;
&#xD;
        -  to compare hypnosis to relaxation on short-term effects on pain,&#xD;
&#xD;
        -  to evaluate the quality of life and the impact of pain on daily life: sleep, mood,&#xD;
           anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of&#xD;
           pain and pain catastrophizing.&#xD;
&#xD;
           35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total&#xD;
           duration for each patient: 8 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">June 22, 2021</completion_date>
  <primary_completion_date type="Actual">June 22, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weekly mean pain intensity in patients diaries</measure>
    <time_frame>9 week</time_frame>
    <description>The pain intensity score will be recorded daily by each patient on a self-assessment diary using a scale of 0 to 10. The record will begin from the first session of hypnosis or relaxation to the last session (S1 to S9).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment</measure>
    <time_frame>8 months</time_frame>
    <description>Pain intensity measured at the end of each hypnosis or relaxation session and 3 and 6 months after the end of the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the feeling of comfort and relaxation</measure>
    <time_frame>9 weeks</time_frame>
    <description>At the end of each hypnosis or relaxation session, with a scale from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affective components of pain</measure>
    <time_frame>8 months</time_frame>
    <description>At the end of each visit and 3 and 6 months after the end of the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional processes and Alexithymia</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic symptoms (NPSI)</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interference with pain (Brief Pain Inventory)</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression and anxiety</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional distress caused by pain</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain catastrophizing</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain relief</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay of onset of analgesic effects</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of responders</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Hypnotic analgesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypnosis sessions:&#xD;
Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Relaxation group:&#xD;
Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients will receive their usual pain treatments throughout the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnosis sessions</intervention_name>
    <description>1 session per week during 8 weeks</description>
    <arm_group_label>Hypnotic analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation group</intervention_name>
    <description>1 relaxation session per week during 8 weeks</description>
    <arm_group_label>Relaxation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  peripheral or central neuropathic pain, probable or definite&#xD;
&#xD;
          -  Diagnostic questionnaire score DN4 ≥ 4/10&#xD;
&#xD;
          -  Chronic Pain with an average of pain intensity greater than or equal to 4/10 (digital&#xD;
             scale)&#xD;
&#xD;
          -  Presence of daily or almost daily pain (i.e. at least 4 days per week)&#xD;
&#xD;
          -  Patient with pre-existing pain for &gt; 6 months&#xD;
&#xD;
          -  Patient &gt; 18 and &lt; 60 years old&#xD;
&#xD;
          -  Patient with a stable analgesic treatment since 15 days before inclusion&#xD;
&#xD;
          -  Patient able to participate to the trial during 33 weeks&#xD;
&#xD;
          -  Patient having a health insurance&#xD;
&#xD;
          -  Written informed consent signed by the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with hypnosis&#xD;
&#xD;
          -  Currently under active psychotherapy (Cognitive-Behavior Therapy, psychoanalysis)&#xD;
&#xD;
          -  Work accident or litigation&#xD;
&#xD;
          -  Drugs abuse or Psychoactive Substance Abuse (DSM-IV)&#xD;
&#xD;
          -  Neuropathic pain associated with progressive disease (MS, HIV, cancer ...)&#xD;
&#xD;
          -  Major depression with ongoing disability or psychosis (DSM IV)&#xD;
&#xD;
          -  Intermittent pain&#xD;
&#xD;
          -  Patient with pre-existing pain for &lt; 6 months&#xD;
&#xD;
          -  Other more severe pain than the pain justifying inclusion&#xD;
&#xD;
          -  Subject unable to understand the trial information provided in the informed consent&#xD;
             document&#xD;
&#xD;
          -  Subject under curators or guardianship&#xD;
&#xD;
          -  Severe Handicap or amputation&#xD;
&#xD;
          -  Participation to another study in the same period&#xD;
&#xD;
          -  Deafness&#xD;
&#xD;
          -  Cognitive disorders (dementia, Mild Cognitive Impairment, inability to understand the&#xD;
             questionnaires)&#xD;
&#xD;
          -  For patients of the control arm: Treatment by hypnosis and / or relaxation,&#xD;
             transcranial magnetic stimulation, or invasive treatments (surgery)&#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>Nadine ATTAL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Hospitalier Ambroise Paré</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <state>Hauts-de-Seine</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuropathic pain</keyword>
  <keyword>Hypnosis</keyword>
  <keyword>Relaxation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02256371
org study id: P130604
nct id: NCT02256371
lead sponsor: 
has dmc: No
A randomized double-blind controlled two centers study. The primary objective of this study
      will be to show a superiority of hypnosis over relaxation on pain intensity in patients with
      neuropathic pain.
The secondary objectives of this study are:

        -  to show a superiority of hypnosis and relaxation over control group on neuropathic pain.

        -  to show a lasting effect of treatment on neuropathic pain one week after the end of
           treatment.

        -  to evaluate the clinical predictors of response to hypnosis (nature of neuropathic
           symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping
           strategies, emotional regulation, response to the first session, positive or negative
           emotional reaction at the end of hypnosis sessions).

        -  to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of
           treatment).

        -  to evaluate the effect of hypnosis on emotional processes.

        -  to compare hypnosis to relaxation on short-term effects on pain,

        -  to evaluate the quality of life and the impact of pain on daily life: sleep, mood,
           anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of
           pain and pain catastrophizing.

           35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total
           duration for each patient: 8 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Weekly mean pain intensity in patients diaries
time frame: 9 week
description: The pain intensity score will be recorded daily by each patient on a self-assessment diary using a scale of 0 to 10. The record will begin from the first session of hypnosis or relaxation to the last session (S1 to S9).
measure: Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment
time frame: 8 months
description: Pain intensity measured at the end of each hypnosis or relaxation session and 3 and 6 months after the end of the treatment
measure: Evaluation of the feeling of comfort and relaxation
time frame: 9 weeks
description: At the end of each hypnosis or relaxation session, with a scale from 0 to 10.
measure: Affective components of pain
time frame: 8 months
description: At the end of each visit and 3 and 6 months after the end of the treatment
measure: Emotional processes and Alexithymia
time frame: 8 months
measure: Neuropathic symptoms (NPSI)
time frame: 8 months
measure: Interference with pain (Brief Pain Inventory)
time frame: 8 months
measure: Quality of life assessment
time frame: 8 months
measure: Depression and anxiety
time frame: 8 months
measure: Emotional distress caused by pain
time frame: 8 months
measure: Pain catastrophizing
time frame: 9 months
measure: Pain relief
time frame: 8 months
measure: Delay of onset of analgesic effects
time frame: 8 weeks
measure: Percentage of responders
time frame: 8 months
arm group label: Hypnotic analgesia
arm group type: Experimental
description: Hypnosis sessions:
Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist
arm group label: Relaxation
arm group type: Experimental
description: Relaxation group:
Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist.
arm group label: Routine care
arm group type: No Intervention
description: The patients will receive their usual pain treatments throughout the study
intervention type: Behavioral
intervention name: Hypnosis sessions
description: 1 session per week during 8 weeks
arm group label: Hypnotic analgesia
intervention type: Behavioral
intervention name: Relaxation group
description: 1 relaxation session per week during 8 weeks
arm group label: Relaxation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nadine ATTAL, MD, PhD
role: Principal Investigator
affiliation: Groupe Hospitalier Ambroise Paré
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuralgia