<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/NCT01716871</url>
  </required_header>
  <id_info>
    <org_study_id>Lagauche 2011-RC-11</org_study_id>
    <secondary_id>2011-A00111-40</secondary_id>
    <nct_id>NCT01716871</nct_id>
  </id_info>
  <brief_title>The Using of NEurocryostimulation in Military Ankle Sprains</brief_title>
  <acronym>TUNEMAS</acronym>
  <official_title>COMPARAISON D'EFFICACITÉ ENTRE LA CRYOTHÉRAPIE GAZEUSE HYPERBARE ET LA CRYOTHÉRAPIE CONVENTIONNELLE DANS LE TRAITEMENT DES ENTORSES EXTERNES DE LA CHEVILLE Étude randomisée auprès d'Une Population de Militaires</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Direction Centrale du Service de Santé des Armées</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Direction Centrale du Service de Santé des Armées</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: The military population is at high-risk for injury with by painful sprains,&#xD;
      especially of the ankle. The referenced treatment method for pain is the cryotherapy,&#xD;
      consisting in applying cold-packs to the injured ankle several times a day. However, another&#xD;
      pain treatment has been developed and is commonly used by high-level sports teams and&#xD;
      rheumatologists but its efficacy has never been assessed within a military population, i.e.&#xD;
      the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.&#xD;
&#xD;
      Research design: This study was carried out on a French multicenter basis, the study&#xD;
      consisting in a randomized controlled superiority trial and open-label prospective analysis&#xD;
      in the treatment of 40-year-old military patients or younger suffering from acute ankle&#xD;
      sprains. Two groups were made: patients were treated either by neurocryostimulation or by the&#xD;
      referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six&#xD;
      supervised 30 minute-sessions within a period of three consecutive days.&#xD;
&#xD;
      Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity&#xD;
      resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we&#xD;
      theorized that the total consumption of paracetamol and the number of days of temporary&#xD;
      inaptitude and of work exemption were lower in patients treated by neurocryostimulation.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning&#xD;
      and at the end of session 20 minutes later after a four-step walk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In France, there is one ankle sprain per 10,000 person/day mainly as a result of athletic&#xD;
      practice. The military population is one of the most physically active populations due to&#xD;
      taking part in sports exercise, scheduled sports periods and leisure sports , or required&#xD;
      military exercise which increase the soldiers' risk for injury to the lower extremity,&#xD;
      especially the ankle. The incidence rate for ankle sprain injuries among all -active-duty US&#xD;
      service members was 34.95 per 1000 person/year , thus more than 5 times greater than&#xD;
      previously reported in civilian studies reported in the literature. These are among the two&#xD;
      first leading causes of sports and physical training related hospitalizations among the U.S.&#xD;
      Army population.&#xD;
&#xD;
      Sprains can lead to numerous consequences in the long-term in physical restrictions such as,&#xD;
      ankle instability, risk of recurrence, but also absenteeism from work and/or participation in&#xD;
      sports and chronic pain. A more efficient treatment seems to be necessary in preventing such&#xD;
      troubles.&#xD;
&#xD;
      The usual care protocol for ankle sprains (RICE protocol) involve the cryotherapy (usually a&#xD;
      cold-pack (R) applied directly to the injury several times a day with no existing undesirable&#xD;
      effects).&#xD;
&#xD;
      An innovative treatment method, the neurocryostimulation, developed by Cluzeau and a French&#xD;
      Company in 1993, gained rapid and wide-spread use among physiotherapists, rheumatologists,&#xD;
      and athletes.It would provide a powerfull anti-inflammatory, myorelaxant and analgesic effect&#xD;
      but contradictory results are shown in literature. Demoulin et al. aimed to assess the&#xD;
      efficacy of neurocryostimulation following total knee arthroplasty compared to routinely used&#xD;
      strategies for applying cold therapy, but didn't show significant differences regarding pain&#xD;
      severity, mobility and perimetric measures. However, a pilot study led in Switzerland,&#xD;
      comparing the pain reported by patients after an acute post-operative knee arthroscopy, has&#xD;
      shown a pain differential higher in the neurocryostimulation than in the referenced&#xD;
      cryotherapy (2.2 versus 0.5). And, Chatap et al. showed in a prospective study that pain&#xD;
      scores decreased significantly after four sessions in elderly patients with acute or chronic&#xD;
      pain.&#xD;
&#xD;
      At this day, No study has proved the efficacy of neurocryostimulation versus cold packs in&#xD;
      pain resulting from an ankle sprain . A better treatment of the ankle sprain could reduce&#xD;
      pain and , in the same time, also reduce the consumption of analgesics, the time of temporary&#xD;
      inaptitudes and of work exemptions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of pain assassed by Visual analogic scale of pain</measure>
    <time_frame>2 times in the morning, 2 times in the evening, 3 days long</time_frame>
    <description>pain is assessed with Visual analogic scale of pain just before the application of cryotherapy (T0) and 20 minutes after the application of cold(T20) right after the patient has taken four-step walk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily consumption of paracetamol</measure>
    <time_frame>every day during 3 days</time_frame>
    <description>The daily analgesic consumption (grams of paracetamol) is also reported in medical records every evening by means of doctor-patient interrogation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>number of days of temporary incapacity of work</measure>
    <time_frame>participants will be followed for the duration of the symptoms (pain, oedema), an expected average of 4 weeks</time_frame>
    <description>The patient must visit the investigator of his center every week, who judges the patient's aptitude to go back to work without any restriction. The investigator will report the total number of days of all temporary inaptitude related to the ankle sprain.</description>
  </other_outcome>
  <other_outcome>
    <measure>number of days of work exemption</measure>
    <time_frame>participants will be followed for the duration of the symptoms (pain, oedema), an expected average of 2 weeks</time_frame>
    <description>The investigator will report,if any, the total number of days of work exempt consecutive to the ankle sprain.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Sprain of Lateral Ligament of Ankle Joint</condition>
  <arm_group>
    <arm_group_label>cryotherapy using Cold pack®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients with lateral ankle sprain who have been randomized in the &quot;cold packs®&quot; group.&#xD;
Application of cryotherapy with Cold pack® or ice-cubes pack in the sprained ankle during 20 minutes 4 times a day, 3 days long.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cryotherapy using Neurocryostimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient with lateral ankle sprain randomized in the &quot;neurocryostimulation&quot; group.&#xD;
Application of neurocryostimulation with Duo-cryo® device during 1 minute on the sprained ankle, 2 times a day, 3 days long</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>neurocryostimulation with Duo-cryo® device</intervention_name>
    <description>organized in the morning and in the evening during 3days. The gaz is sprayed with Duo-cryo® device on dry skin over the ankle using a slow, regular, sweeping movement. The tip of the nozzle is kept 15 to 20 cm away from the skin. Neurocryostimulation is applied to patients for a duration of one minute by a trained staff</description>
    <arm_group_label>cryotherapy using Neurocryostimulation</arm_group_label>
    <other_name>hyperbaric gazeous cryotherapy</other_name>
    <other_name>neurocryostimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cryotherapy with Cold pack® or ice-cubes pack</intervention_name>
    <description>Patients receive 2 controlled applications a day (one in the morning and one in the evening) of cryotherapy with Cold pack® or ice-cubes pack (with average dimensions of 5 cm by 8 cm) to the injury site for a duration of 20 minutes. Furthermore, the patients are instructed to do 2 more applications of the ice-pack during the daytime to follow the usual recommendations.&#xD;
The first and last sessions of each day must be supervised by the medical care Unit to insure standardized data collection for each group.</description>
    <arm_group_label>cryotherapy using Cold pack®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        age equal or less than 40 years-old, military subject, acute ankle injury, To have&#xD;
        completed and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        contraindications to cryotherapy ( cold allergy, cryoglobulinemia, Raynaud's phenomenon,&#xD;
        cutaneous sensory abnormalities, and diabetes mellitus), paracetamol allergy, 4th grade&#xD;
        sprains according to the Trevino Classification (with bone wrenching), to take analgesic or&#xD;
        anti-inflammatory treatment other than paracetamol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas VERTU, Interne</last_name>
    <role>Principal Investigator</role>
    <affiliation>Direction Centrale du Service de Santé des Armées</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Denis LAGAUCHE, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Direction Centrale du Service de Santé des Armées</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alain COURTIERE, Pharmacien</last_name>
    <role>Study Chair</role>
    <affiliation>Direction Centrale du Service de Santé des Armées</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>CREDORC</last_name>
    <phone>+33387562427</phone>
    <email>credorc@hia-legouest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>DCSSA</name>
      <address>
        <city>Paris</city>
        <zip>75000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>courtiere Alain, PHD</last_name>
      <phone>0169237174</phone>
      <email>acourtiere@imassa.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Direction Centrale du Service de Santé des Armées</investigator_affiliation>
    <investigator_full_name>Nicolas Vertu</investigator_full_name>
    <investigator_title>Interne des Hôpitaux des Armées</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sprains and Strains</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/NCT01716871
org study id: Lagauche 2011-RC-11
secondary id: 2011-A00111-40
nct id: NCT01716871
lead sponsor: 
has dmc: No
Introduction: The military population is at high-risk for injury with by painful sprains,
      especially of the ankle. The referenced treatment method for pain is the cryotherapy,
      consisting in applying cold-packs to the injured ankle several times a day. However, another
      pain treatment has been developed and is commonly used by high-level sports teams and
      rheumatologists but its efficacy has never been assessed within a military population, i.e.
      the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.

      Research design: This study was carried out on a French multicenter basis, the study
      consisting in a randomized controlled superiority trial and open-label prospective analysis
      in the treatment of 40-year-old military patients or younger suffering from acute ankle
      sprains. Two groups were made: patients were treated either by neurocryostimulation or by the
      referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six
      supervised 30 minute-sessions within a period of three consecutive days.

      Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity
      resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we
      theorized that the total consumption of paracetamol and the number of days of temporary
      inaptitude and of work exemption were lower in patients treated by neurocryostimulation.

      Outcomes:

      For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning
      and at the end of session 20 minutes later after a four-step walk.
In France, there is one ankle sprain per 10,000 person/day mainly as a result of athletic
      practice. The military population is one of the most physically active populations due to
      taking part in sports exercise, scheduled sports periods and leisure sports , or required
      military exercise which increase the soldiers' risk for injury to the lower extremity,
      especially the ankle. The incidence rate for ankle sprain injuries among all -active-duty US
      service members was 34.95 per 1000 person/year , thus more than 5 times greater than
      previously reported in civilian studies reported in the literature. These are among the two
      first leading causes of sports and physical training related hospitalizations among the U.S.
      Army population.

      Sprains can lead to numerous consequences in the long-term in physical restrictions such as,
      ankle instability, risk of recurrence, but also absenteeism from work and/or participation in
      sports and chronic pain. A more efficient treatment seems to be necessary in preventing such
      troubles.

      The usual care protocol for ankle sprains (RICE protocol) involve the cryotherapy (usually a
      cold-pack (R) applied directly to the injury several times a day with no existing undesirable
      effects).

      An innovative treatment method, the neurocryostimulation, developed by Cluzeau and a French
      Company in 1993, gained rapid and wide-spread use among physiotherapists, rheumatologists,
      and athletes.It would provide a powerfull anti-inflammatory, myorelaxant and analgesic effect
      but contradictory results are shown in literature. Demoulin et al. aimed to assess the
      efficacy of neurocryostimulation following total knee arthroplasty compared to routinely used
      strategies for applying cold therapy, but didn't show significant differences regarding pain
      severity, mobility and perimetric measures. However, a pilot study led in Switzerland,
      comparing the pain reported by patients after an acute post-operative knee arthroscopy, has
      shown a pain differential higher in the neurocryostimulation than in the referenced
      cryotherapy (2.2 versus 0.5). And, Chatap et al. showed in a prospective study that pain
      scores decreased significantly after four sessions in elderly patients with acute or chronic
      pain.

      At this day, No study has proved the efficacy of neurocryostimulation versus cold packs in
      pain resulting from an ankle sprain . A better treatment of the ankle sprain could reduce
      pain and , in the same time, also reduce the consumption of analgesics, the time of temporary
      inaptitudes and of work exemptions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evolution of pain assassed by Visual analogic scale of pain
time frame: 2 times in the morning, 2 times in the evening, 3 days long
description: pain is assessed with Visual analogic scale of pain just before the application of cryotherapy (T0) and 20 minutes after the application of cold(T20) right after the patient has taken four-step walk.
measure: Daily consumption of paracetamol
time frame: every day during 3 days
description: The daily analgesic consumption (grams of paracetamol) is also reported in medical records every evening by means of doctor-patient interrogation.
measure: number of days of temporary incapacity of work
time frame: participants will be followed for the duration of the symptoms (pain, oedema), an expected average of 4 weeks
description: The patient must visit the investigator of his center every week, who judges the patient's aptitude to go back to work without any restriction. The investigator will report the total number of days of all temporary inaptitude related to the ankle sprain.
measure: number of days of work exemption
time frame: participants will be followed for the duration of the symptoms (pain, oedema), an expected average of 2 weeks
description: The investigator will report,if any, the total number of days of work exempt consecutive to the ankle sprain.
arm group label: cryotherapy using Cold pack®
arm group type: Active Comparator
description: patients with lateral ankle sprain who have been randomized in the "cold packs®" group.
Application of cryotherapy with Cold pack® or ice-cubes pack in the sprained ankle during 20 minutes 4 times a day, 3 days long.
arm group label: cryotherapy using Neurocryostimulation
arm group type: Active Comparator
description: Patient with lateral ankle sprain randomized in the "neurocryostimulation" group.
Application of neurocryostimulation with Duo-cryo® device during 1 minute on the sprained ankle, 2 times a day, 3 days long
intervention type: Device
intervention name: neurocryostimulation with Duo-cryo® device
description: organized in the morning and in the evening during 3days. The gaz is sprayed with Duo-cryo® device on dry skin over the ankle using a slow, regular, sweeping movement. The tip of the nozzle is kept 15 to 20 cm away from the skin. Neurocryostimulation is applied to patients for a duration of one minute by a trained staff
arm group label: cryotherapy using Neurocryostimulation
other name: hyperbaric gazeous cryotherapy
other name: neurocryostimulation
intervention type: Device
intervention name: cryotherapy with Cold pack® or ice-cubes pack
description: Patients receive 2 controlled applications a day (one in the morning and one in the evening) of cryotherapy with Cold pack® or ice-cubes pack (with average dimensions of 5 cm by 8 cm) to the injury site for a duration of 20 minutes. Furthermore, the patients are instructed to do 2 more applications of the ice-pack during the daytime to follow the usual recommendations.
The first and last sessions of each day must be supervised by the medical care Unit to insure standardized data collection for each group.
arm group label: cryotherapy using Cold pack®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Nicolas VERTU, Interne
role: Principal Investigator
affiliation: Direction Centrale du Service de Santé des Armées
last name: Denis LAGAUCHE, Dr
role: Study Director
affiliation: Direction Centrale du Service de Santé des Armées
last name: Alain COURTIERE, Pharmacien
role: Study Chair
affiliation: Direction Centrale du Service de Santé des Armées
last name: CREDORC
phone: +33387562427
email: credorc@hia-legouest.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Direction Centrale du Service de Santé des Armées
investigator full name: Nicolas Vertu
investigator title: Interne des Hôpitaux des Armées
mesh term: Sprains and Strains