<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/NCT02252276</url>
  </required_header>
  <id_info>
    <org_study_id>M2013/031/20131120</org_study_id>
    <nct_id>NCT02252276</nct_id>
  </id_info>
  <brief_title>Effects of Manual Therapy and Exercise in the Treatment of Ankle Sprains</brief_title>
  <official_title>Effects of Manual Therapy and Exercise in the Treatment of Recurrent Ankle Sprains: Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the&#xD;
      same exercises and manual therapy on the recurrent ankle sprain management.&#xD;
&#xD;
      Design: A randomized clinical trial with two intervention groups and triple blind.&#xD;
&#xD;
      Settings: University Hospital.&#xD;
&#xD;
      Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular&#xD;
      sports practice and pain during the physical activity, randomly assigned to experimental or&#xD;
      control group.&#xD;
&#xD;
      Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises;&#xD;
      experimental group performed 4 weeks of the same exercises combined with manual therapy.&#xD;
&#xD;
      Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle&#xD;
      eversion strength, and active range of motion in ankle joint. The measures were taken before,&#xD;
      after and one month after the interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recurrent ankle sprain means the most frequent complication from the ankle sprain and the&#xD;
      previous phase of the chronic ankle stability (CAI), which involves between 20 - 41% of all&#xD;
      ankle sprains.&#xD;
&#xD;
      Residual pain concerns the first symptom after instability in most of the cases, but patients&#xD;
      also show reduced ankle joint position sense, ankle range of motion, and strength of ankle&#xD;
      inversion muscles.&#xD;
&#xD;
      Proprioception exercises on multiplane and unstable platforms, as well as strengthening&#xD;
      through eccentric exercises report benefits in pain and function, suggesting the active&#xD;
      therapy as the most effective treatment instead of passive manual therapy in chronic phases.&#xD;
&#xD;
      However, several studies analyzed the effects of the manual therapy in the management of the&#xD;
      ankle sprain recurrence: the posterior gliding of astragalus and the tibiotarsal joint&#xD;
      coaptation improved the ankle range of motion, which was related with recurrent ankle sprain&#xD;
      and its residual symptoms.&#xD;
&#xD;
      Despite the benefits from active and passive therapy, very few authors up to date&#xD;
      investigated the combination of both clinical approach in the recurrent ankle sprain.&#xD;
      Literature analyzed the effects of a combined program including exercises to the manual&#xD;
      therapy in acute ankle sprain and concluded that the variety in the manual therapy techniques&#xD;
      reported more pain release and improved function.&#xD;
&#xD;
      Besides, based on the effects of joint mobilization techniques, the neurodynamic mobilization&#xD;
      could be an appropriate therapy, due to the neural distribution of fibular nerve through the&#xD;
      ankle joint, but no studies to date to our knowledge included this technique as part of the&#xD;
      recurrent ankle sprain management.&#xD;
&#xD;
      This study aimed to analyze the effects of proprioceptive and strengthening exercises versus&#xD;
      the same exercises and manual therapy on the recurrent ankle sprain management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Change from baseline at one month</time_frame>
    <description>All the subjects showed their pain level from 0 (no pain) to 10 (maximum pain) in a Visual Analogical Scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Cumberland Ankle Instability Tool (CAIT)</measure>
    <time_frame>Change from baseline at one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain Threshold (PPT)</measure>
    <time_frame>Change from baseline at one month</time_frame>
    <description>An algometer Wagner FPI 10-WA was used to determine the PPT in the anterior talofibular ligament, the calcaneofibular ligament, tibial malleolus, and fibular malleolus. The pressure was perpendicular hold in each structure, while patients were positioned sidelined on the unaffected side with knee and hip semiflexion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Active range of motion in ankle joint</measure>
    <time_frame>Change from baseline at one month</time_frame>
    <description>A standard goniometer was employed. Patients were seated in 90º knee flexion and ankle neutral position. The goniometer fulcrum was placed over the lateral malleolus, with its proximal arm over the fibular diaphysis and distal arm over the fifth metatarsal. Patients were asked to actively perform a flexion and extension of ankle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength in ankle flexion and extension</measure>
    <time_frame>Change from baseline at one month</time_frame>
    <description>dynamic dynamometry with MicroFet-2 was used while patients were positioned in supine and lower limb on the therapeutic table. From this position, patients performed ankle flexion and extension. The test-retest reliability of this tool has been previously shown</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Ankle Sprains</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>performed the same exercises and manual therapy during 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>performed proprioceptive and strengthening exercises during 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Experimental (proprioception exercises, muscle strengthening, joint mobilization)</intervention_name>
    <description>The experimental group performed a combined protocol of proprioception (the patient doing exercises standing on an unstable plane)exercises and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle), and joint mobilization techniques of the ankle joint two session per week, during four weeks</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control (proprioception exercises, muscle strengthening)</intervention_name>
    <description>The control group performed only proprioception exercises (the patient doing exercises standing on an unstable plane) and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle). Two sessión per week during four weeks</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with previous history of recurrent ankle sprain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with surgical treatment, previous fractures on lower limb and/or adjacent&#xD;
             pathologies were excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomas Gallego-Izquierdo, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alcala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcalá University</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28871</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Daniel Pecos Martín</investigator_full_name>
    <investigator_title>Dr Daniel Pecos Martín</investigator_title>
  </responsible_party>
  <keyword>Manual therapy</keyword>
  <keyword>proprioception</keyword>
  <keyword>exercises</keyword>
  <keyword>ankle sprain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sprains and Strains</mesh_term>
    <mesh_term>Ankle Injuries</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/NCT02252276
org study id: M2013/031/20131120
nct id: NCT02252276
lead sponsor: 
has dmc: Yes
Objectives: To analyze the effects of proprioceptive and strengthening exercises versus the
      same exercises and manual therapy on the recurrent ankle sprain management.

      Design: A randomized clinical trial with two intervention groups and triple blind.

      Settings: University Hospital.

      Participants: Fifty-four patients with previous history of recurrent ankle sprains, regular
      sports practice and pain during the physical activity, randomly assigned to experimental or
      control group.

      Intervention: Control group performed 4 weeks of proprioceptive and strengthening exercises;
      experimental group performed 4 weeks of the same exercises combined with manual therapy.

      Main Outcomes Measures: Pain, ankle instability, pressure pain threshold (PPT), ankle
      eversion strength, and active range of motion in ankle joint. The measures were taken before,
      after and one month after the interventions.
The recurrent ankle sprain means the most frequent complication from the ankle sprain and the
      previous phase of the chronic ankle stability (CAI), which involves between 20 - 41% of all
      ankle sprains.

      Residual pain concerns the first symptom after instability in most of the cases, but patients
      also show reduced ankle joint position sense, ankle range of motion, and strength of ankle
      inversion muscles.

      Proprioception exercises on multiplane and unstable platforms, as well as strengthening
      through eccentric exercises report benefits in pain and function, suggesting the active
      therapy as the most effective treatment instead of passive manual therapy in chronic phases.

      However, several studies analyzed the effects of the manual therapy in the management of the
      ankle sprain recurrence: the posterior gliding of astragalus and the tibiotarsal joint
      coaptation improved the ankle range of motion, which was related with recurrent ankle sprain
      and its residual symptoms.

      Despite the benefits from active and passive therapy, very few authors up to date
      investigated the combination of both clinical approach in the recurrent ankle sprain.
      Literature analyzed the effects of a combined program including exercises to the manual
      therapy in acute ankle sprain and concluded that the variety in the manual therapy techniques
      reported more pain release and improved function.

      Besides, based on the effects of joint mobilization techniques, the neurodynamic mobilization
      could be an appropriate therapy, due to the neural distribution of fibular nerve through the
      ankle joint, but no studies to date to our knowledge included this technique as part of the
      recurrent ankle sprain management.

      This study aimed to analyze the effects of proprioceptive and strengthening exercises versus
      the same exercises and manual therapy on the recurrent ankle sprain management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Pain
time frame: Change from baseline at one month
description: All the subjects showed their pain level from 0 (no pain) to 10 (maximum pain) in a Visual Analogical Scale (VAS).
measure: The Cumberland Ankle Instability Tool (CAIT)
time frame: Change from baseline at one month
measure: Pressure Pain Threshold (PPT)
time frame: Change from baseline at one month
description: An algometer Wagner FPI 10-WA was used to determine the PPT in the anterior talofibular ligament, the calcaneofibular ligament, tibial malleolus, and fibular malleolus. The pressure was perpendicular hold in each structure, while patients were positioned sidelined on the unaffected side with knee and hip semiflexion
measure: Active range of motion in ankle joint
time frame: Change from baseline at one month
description: A standard goniometer was employed. Patients were seated in 90º knee flexion and ankle neutral position. The goniometer fulcrum was placed over the lateral malleolus, with its proximal arm over the fibular diaphysis and distal arm over the fifth metatarsal. Patients were asked to actively perform a flexion and extension of ankle.
measure: Strength in ankle flexion and extension
time frame: Change from baseline at one month
description: dynamic dynamometry with MicroFet-2 was used while patients were positioned in supine and lower limb on the therapeutic table. From this position, patients performed ankle flexion and extension. The test-retest reliability of this tool has been previously shown
arm group label: Experimental
arm group type: Experimental
description: performed the same exercises and manual therapy during 4 weeks
arm group label: Control
arm group type: Active Comparator
description: performed proprioceptive and strengthening exercises during 4 weeks
intervention type: Procedure
intervention name: Experimental (proprioception exercises, muscle strengthening, joint mobilization)
description: The experimental group performed a combined protocol of proprioception (the patient doing exercises standing on an unstable plane)exercises and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle), and joint mobilization techniques of the ankle joint two session per week, during four weeks
arm group label: Experimental
intervention type: Procedure
intervention name: Control (proprioception exercises, muscle strengthening)
description: The control group performed only proprioception exercises (the patient doing exercises standing on an unstable plane) and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle). Two sessión per week during four weeks
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tomas Gallego-Izquierdo, Dr
role: Principal Investigator
affiliation: Alcala University
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Prof. Dr. Daniel Pecos Martín
investigator title: Dr Daniel Pecos Martín
mesh term: Sprains and Strains
mesh term: Ankle Injuries