<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/NCT03248505</url>
  </required_header>
  <id_info>
    <org_study_id>TENS_LBP</org_study_id>
    <nct_id>NCT03248505</nct_id>
  </id_info>
  <brief_title>Cryotherapy and TENS on Low Back Pain</brief_title>
  <acronym>CTLBP</acronym>
  <official_title>Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</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>
      This study aim analyze the immediate effects of conventional transcutaneous electrical nerve&#xD;
      stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with&#xD;
      non-specific low back pain.&#xD;
&#xD;
      All subjects will be submitted to an evaluation of the painful sensation, through the&#xD;
      numerical rating scale, and pain threshold, through algometry, before, immediately after the&#xD;
      intervention and 25 minutes after.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>3x6</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Painful sensation</measure>
    <time_frame>Evaluation of pain sensation 25 minutes after the application of the intervention.</time_frame>
    <description>Pain sensation measured by pain numerical rating scale</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Low Back Pain, Mechanical</condition>
  <arm_group>
    <arm_group_label>Placebo TENS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TENS unit turned on, but with zero amplitude.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional TENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Burst TENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cryotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1,5 Kg crushed ice pack</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Burst TENS + Cryotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional TENS + Cryotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional TENS</intervention_name>
    <description>Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal.</description>
    <arm_group_label>Conventional TENS</arm_group_label>
    <other_name>Transcutaneous Electrical Nerve Stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Burst TENS</intervention_name>
    <description>Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.</description>
    <arm_group_label>Burst TENS</arm_group_label>
    <other_name>Burst-modulated TENS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cryotherapy</intervention_name>
    <description>1,5 Kg of crushed ice pack on lumbar spine.</description>
    <arm_group_label>Cryotherapy</arm_group_label>
    <other_name>Ice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Burst TENS + Cryotherapy</intervention_name>
    <description>Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine.</description>
    <arm_group_label>Burst TENS + Cryotherapy</arm_group_label>
    <other_name>Burst-modulated TENS and Ice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional TENS + Cryotherapy</intervention_name>
    <description>Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine.</description>
    <arm_group_label>Conventional TENS + Cryotherapy</arm_group_label>
    <other_name>Transcutaneous Electrical Nerve Stimulation + Ice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo TENS</intervention_name>
    <description>TENS device turned on, but with zero amplitude.</description>
    <arm_group_label>Placebo TENS</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 50 years;&#xD;
&#xD;
          -  Have chronic non-specific low back pain.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as&#xD;
             ankylosing spondylitis);&#xD;
&#xD;
          -  Nerve root compromise (disc herniation and spondylolisthesis with neurological&#xD;
             compromise, spinal stenosis, and others);&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Corticosteroid treatment in the previous two weeks;&#xD;
&#xD;
          -  Antiinflammatory treatment in the previous 24 hours;&#xD;
&#xD;
          -  Contraindications to the use of Kinesio Taping (allergy or intolerance);&#xD;
&#xD;
          -  Score of three or less on Visual Analogue Scale of the first day;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Ice allergy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jamilson S Brasileiro, PhD</last_name>
    <phone>+55 84 3342-2015</phone>
    <email>brasileiro@ufrnet.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal University of Rio Grande do Norte</name>
      <address>
        <city>Natal</city>
        <state>RN</state>
        <zip>59140-840</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamilson S Brasileiro, PhD</last_name>
      <phone>+55 84 3342-2008</phone>
      <email>brasileiro@ufrnet.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Jamilson Simões Brasileiro</investigator_full_name>
    <investigator_title>Professor of Physiotherapy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03248505
org study id: TENS_LBP
nct id: NCT03248505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aim analyze the immediate effects of conventional transcutaneous electrical nerve
      stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with
      non-specific low back pain.

      All subjects will be submitted to an evaluation of the painful sensation, through the
      numerical rating scale, and pain threshold, through algometry, before, immediately after the
      intervention and 25 minutes after.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3x6
primary purpose: Treatment
masking: None (Open Label)
measure: Painful sensation
time frame: Evaluation of pain sensation 25 minutes after the application of the intervention.
description: Pain sensation measured by pain numerical rating scale
arm group label: Placebo TENS
arm group type: Placebo Comparator
description: TENS unit turned on, but with zero amplitude.
arm group label: Conventional TENS
arm group type: Experimental
description: Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.
arm group label: Burst TENS
arm group type: Experimental
description: Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
arm group label: Cryotherapy
arm group type: Experimental
description: 1,5 Kg crushed ice pack
arm group label: Burst TENS + Cryotherapy
arm group type: Experimental
description: Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg.
arm group label: Conventional TENS + Cryotherapy
arm group type: Experimental
description: Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg.
intervention type: Device
intervention name: Conventional TENS
description: Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal.
arm group label: Conventional TENS
other name: Transcutaneous Electrical Nerve Stimulation
intervention type: Device
intervention name: Burst TENS
description: Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
arm group label: Burst TENS
other name: Burst-modulated TENS
intervention type: Other
intervention name: Cryotherapy
description: 1,5 Kg of crushed ice pack on lumbar spine.
arm group label: Cryotherapy
other name: Ice
intervention type: Device
intervention name: Burst TENS + Cryotherapy
description: Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine.
arm group label: Burst TENS + Cryotherapy
other name: Burst-modulated TENS and Ice
intervention type: Device
intervention name: Conventional TENS + Cryotherapy
description: Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine.
arm group label: Conventional TENS + Cryotherapy
other name: Transcutaneous Electrical Nerve Stimulation + Ice
intervention type: Other
intervention name: Placebo TENS
description: TENS device turned on, but with zero amplitude.
arm group label: Placebo TENS
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jamilson S Brasileiro, PhD
phone: +55 84 3342-2015
email: brasileiro@ufrnet.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Jamilson Simões Brasileiro
investigator title: Professor of Physiotherapy
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided