<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/NCT04483128</url>
  </required_header>
  <id_info>
    <org_study_id>CIFSNA2020</org_study_id>
    <nct_id>NCT04483128</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.</brief_title>
  <official_title>Electrical Stimulation With Interferential Current in the Non-especific Chronic Low Back Pain: Effects on the Autonomic Nervous System.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Seville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Seville</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>
      The aim of this study it's to analyze the relationship between autonomic nervous system&#xD;
      balance (ANSb) and chronic pain conditions, especially in this case, non-especific chronic&#xD;
      low back pain (CLBP).&#xD;
&#xD;
      Most of physiotherapy approaches focus only in biomechanical aspects, leaving aside what kind&#xD;
      of factors could perpetuate CLBP. Since 1985, ANSb was studied due to its potential&#xD;
      contribution to chronic pain.&#xD;
&#xD;
      Electrical stimulation, through interferential currents (IFC), it's a safe and well-known&#xD;
      therapy used in CLBP with good outcomes regarding pain relief.&#xD;
&#xD;
      The main objective of this study it's to quantify the association between CLBP and ANSb&#xD;
      alterations. In second place, the research team aims to record the influence of IFC over pain&#xD;
      and ANSb in those subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first place, a meeting will be organized with the patients to resolve any doubt about&#xD;
      the study and its process. The investigators will make sure every instruction is&#xD;
      understandable, giving enough time to read and ask pertinent questions.&#xD;
&#xD;
      Secondly, patients will be provided of an informed consent specific for the present study,&#xD;
      according to the legal forms. Participants must agree with all the information and sign the&#xD;
      document.&#xD;
&#xD;
      At this point, patients will be interviewed individually by a researcher to collect all the&#xD;
      data regarding to the Clinical History in Physiotherapy.&#xD;
&#xD;
      In the next step, patients will be randomized into two different groups by choosing one&#xD;
      opaque envelope, containing a number for the allocation. A researcher will make the final&#xD;
      allocation depending on the number. Patients were unaware of the group allocation for&#xD;
      masking.&#xD;
&#xD;
      This study has to possible groups with a common indication for both:&#xD;
&#xD;
        1. Experimental group: Patients allocated in this group will receive one single session of&#xD;
           interferential current (IFC). Current used a carrier frequency of 4.000 Hz, 65Hz of&#xD;
           amplitude modulated frequency (AMF) with sweep frecuency of 95Hz in a 1:1 swing pattern&#xD;
           (quadripolar technique). Intensity was adjusted according to patient's tolerance without&#xD;
           visible muscle twitches. The session will last 25 min.&#xD;
&#xD;
        2. Control group: This group will receive the same intervention than experimental one but&#xD;
           with no intensity, for 25 minutes. Patients will keep his general practitioner's&#xD;
           indications about pharmacology.&#xD;
&#xD;
        3. Common indication: Both groups will get instructions to perform a set of home-based&#xD;
           exercises for core strengthening after variable collecting.&#xD;
&#xD;
      Before and after the session, all the variable measurements will be collected in the same&#xD;
      environmental conditions by the same researcher. Basal measurement (before intervention) will&#xD;
      be recorded 15 minutes before session for 10 minutes. The second measurement will be taken&#xD;
      while the patient recieves the intervention for 20 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</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>Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each:&#xD;
Experimental group: Participants in this group will receive electrical stimulation with interferential current. They will get also instructions to perform core strengthening exercises at home, after variable collection.&#xD;
Control group: Participants in this group will recieve the same electrical stimulation than in the experimental group but with no intensity. This group will get too instructions to perform core strengthening exercises at home (after variable collection) and follow General Practitioner indications about pharmacology.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Randomization process will be masked by opaques envelopes with numbers. Participants choose one random envelope, unaware the number and group relation. Later, a researcher will associate participants, groups and numbers.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate variability (HRV-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.</time_frame>
    <description>Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate variability (HRV-b)</measure>
    <time_frame>Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.</time_frame>
    <description>Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Root-mean-square differences of successive heartbeat intervals (RMSSD-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.</time_frame>
    <description>RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Root-mean-square differences of successive heartbeat intervals (RMSSD-b)</measure>
    <time_frame>Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.</time_frame>
    <description>RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Deviation 1 (SD1-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.</time_frame>
    <description>SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Deviation 1 (SD1-b)</measure>
    <time_frame>Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.</time_frame>
    <description>SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Deviation 2 (SD2-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.</time_frame>
    <description>SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Standard Deviation 2 (SD2-b)</measure>
    <time_frame>Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.</time_frame>
    <description>SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress Index (SS-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.</time_frame>
    <description>SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress Index (SS-b)</measure>
    <time_frame>Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.</time_frame>
    <description>SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sympathetic / Parasympathetic Ratio (S/PS Ratio-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.</time_frame>
    <description>S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)</measure>
    <time_frame>Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.</time_frame>
    <description>S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale (NPRS-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention.</time_frame>
    <description>NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale (NPRS-b)</measure>
    <time_frame>Evaluation immediately after treatment session.</time_frame>
    <description>NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Roland Morris Questionnaire (RMQ-a)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention.</time_frame>
    <description>RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roland Morris Questionnaire (RMQ-b)</measure>
    <time_frame>Evaluation immediately after treatment session.</time_frame>
    <description>RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scale for Personal Psychological Apprehension (SPPA)</measure>
    <time_frame>Evaluation before intervention (basal): 15 minutes before intervention.</time_frame>
    <description>SPPA it's a questionnaire made to measure subject's susceptibility to receive electrical stimulation. A scoring of &gt;45 points indicates that subject shouldnt be treated with electrical therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetry achieved with electrical stimulation</measure>
    <time_frame>Recorded immediately after treatment session.</time_frame>
    <description>Maximal dosimetry reached during the session will be recorded in mA.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Chronic Low-back Pain</condition>
  <condition>Chronic Pain</condition>
  <condition>Autonomic Imbalance</condition>
  <arm_group>
    <arm_group_label>Sham IFC therapy: Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).&#xD;
IFC parameters:&#xD;
Carrier frequency of 4000 Hz&#xD;
Amplitude modulated frequency of 65 Hz (AMF)&#xD;
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.&#xD;
NO intensity (0 mA)&#xD;
Session duration: 25 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IFC therapy: Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).&#xD;
IFC parameters:&#xD;
Carrier frequency of 4000 Hz&#xD;
Amplitude modulated frequency of 65 Hz (AMF)&#xD;
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.&#xD;
Intensity will depend on subjet's tolerance but without generating visible muscle twitches.&#xD;
Session duration: 25 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical stimulation: Interferential Current (IFC): Experimental Group</intervention_name>
    <description>Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:&#xD;
Carrier frequency of 4000 Hz&#xD;
Amplitude modulated frequency of 65 Hz (AMF)&#xD;
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.&#xD;
Intensity will depend on subjet's tolerance but without generate visible muscle twitches.&#xD;
Session duration: 25 minutes</description>
    <arm_group_label>IFC therapy: Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical stimulation: Interferential Current (IFC): Control Group</intervention_name>
    <description>Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:&#xD;
Carrier frequency of 4000 Hz&#xD;
Amplitude modulated frequency of 65 Hz (AMF)&#xD;
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.&#xD;
NO intensity (0 mA)&#xD;
Session duration: 25 minutes</description>
    <arm_group_label>Sham IFC therapy: Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosed with cronic low back pain with at least 3 months of evolution.&#xD;
&#xD;
          -  Subjects with a minimal pain of 3/10 according to NPRS&#xD;
&#xD;
          -  Subjects with informed consent read and signed.&#xD;
&#xD;
          -  Subjects not undergoing any other physical therapy intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any uncontrolled neurological or cardiac disorder.&#xD;
&#xD;
          -  Personal Psychological Apprehension Scale (PPAS) score higher than 37.5.&#xD;
&#xD;
          -  Contraindication for electrical stimulation.&#xD;
&#xD;
          -  Any regular use of medications known to affect the function of the autonomic nervous&#xD;
             system (ANS) or pain perception, including antidepressant, benzodiazepines,&#xD;
             anti-inflammatory drugs and beta-blockers, 2 weeks before participating in this study.&#xD;
&#xD;
          -  Ineligibility to participate determined by the researches.&#xD;
&#xD;
          -  Neurological, musculoskeletal or sensory affectations.&#xD;
&#xD;
          -  Evidence of infectious process, fever or hypotension.&#xD;
&#xD;
          -  Metallic implants in low back area or treated area&#xD;
&#xD;
          -  No surgical interventions in low back area&#xD;
&#xD;
          -  Not being under pharmacological treatment with influence in Autonomic Nervous System&#xD;
             like antidepressants.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Manuel Albornoz Cabello</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Seville</investigator_affiliation>
    <investigator_full_name>Dr. Manuel Albornoz Cabello</investigator_full_name>
    <investigator_title>Doctor in Physiotherapy (PhD)</investigator_title>
  </responsible_party>
  <keyword>electrical stimulation</keyword>
  <keyword>interferential current</keyword>
  <keyword>autonomic balance</keyword>
  <keyword>chronic low back pain</keyword>
  <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>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <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/NCT04483128
org study id: CIFSNA2020
nct id: NCT04483128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study it's to analyze the relationship between autonomic nervous system
      balance (ANSb) and chronic pain conditions, especially in this case, non-especific chronic
      low back pain (CLBP).

      Most of physiotherapy approaches focus only in biomechanical aspects, leaving aside what kind
      of factors could perpetuate CLBP. Since 1985, ANSb was studied due to its potential
      contribution to chronic pain.

      Electrical stimulation, through interferential currents (IFC), it's a safe and well-known
      therapy used in CLBP with good outcomes regarding pain relief.

      The main objective of this study it's to quantify the association between CLBP and ANSb
      alterations. In second place, the research team aims to record the influence of IFC over pain
      and ANSb in those subjects.
In the first place, a meeting will be organized with the patients to resolve any doubt about
      the study and its process. The investigators will make sure every instruction is
      understandable, giving enough time to read and ask pertinent questions.

      Secondly, patients will be provided of an informed consent specific for the present study,
      according to the legal forms. Participants must agree with all the information and sign the
      document.

      At this point, patients will be interviewed individually by a researcher to collect all the
      data regarding to the Clinical History in Physiotherapy.

      In the next step, patients will be randomized into two different groups by choosing one
      opaque envelope, containing a number for the allocation. A researcher will make the final
      allocation depending on the number. Patients were unaware of the group allocation for
      masking.

      This study has to possible groups with a common indication for both:

        1. Experimental group: Patients allocated in this group will receive one single session of
           interferential current (IFC). Current used a carrier frequency of 4.000 Hz, 65Hz of
           amplitude modulated frequency (AMF) with sweep frecuency of 95Hz in a 1:1 swing pattern
           (quadripolar technique). Intensity was adjusted according to patient's tolerance without
           visible muscle twitches. The session will last 25 min.

        2. Control group: This group will receive the same intervention than experimental one but
           with no intensity, for 25 minutes. Patients will keep his general practitioner's
           indications about pharmacology.

        3. Common indication: Both groups will get instructions to perform a set of home-based
           exercises for core strengthening after variable collecting.

      Before and after the session, all the variable measurements will be collected in the same
      environmental conditions by the same researcher. Basal measurement (before intervention) will
      be recorded 15 minutes before session for 10 minutes. The second measurement will be taken
      while the patient recieves the intervention for 20 minutes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants diagnosed with chronic low back pain will be divided into two different groups with 28 patients each:
Experimental group: Participants in this group will receive electrical stimulation with interferential current. They will get also instructions to perform core strengthening exercises at home, after variable collection.
Control group: Participants in this group will recieve the same electrical stimulation than in the experimental group but with no intensity. This group will get too instructions to perform core strengthening exercises at home (after variable collection) and follow General Practitioner indications about pharmacology.
primary purpose: Basic Science
masking: Single (Participant)
masking description: Randomization process will be masked by opaques envelopes with numbers. Participants choose one random envelope, unaware the number and group relation. Later, a researcher will associate participants, groups and numbers.
measure: Heart Rate variability (HRV-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
description: Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
measure: Heart Rate variability (HRV-b)
time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
description: Heart Rate variability (HRV) is measured by calculating mean HR, maximum HR and minimum HR. First Beat Bodyguard2 device will be used to collect HRV.
measure: Root-mean-square differences of successive heartbeat intervals (RMSSD-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
description: RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
measure: Root-mean-square differences of successive heartbeat intervals (RMSSD-b)
time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
description: RMSSD it's an indirect indicator of parasympathic nervous system level of activity. First Beat Bodyguard2 device will be used to collect RMSSD.
measure: Standard Deviation 1 (SD1-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
description: SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
measure: Standard Deviation 1 (SD1-b)
time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.
description: SD1 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
measure: Standard Deviation 2 (SD2-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
description: SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
measure: Standard Deviation 2 (SD2-b)
time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
description: SD2 is an indicator of the autonomic nervous balance. First Beat Bodyguard2 device will be used to collect it.
measure: Stress Index (SS-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
description: SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
measure: Stress Index (SS-b)
time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
description: SS it's an indicator of sympathetic nervous system level of activation. First Beat Bodyguard2 device will be used to collect SS.
measure: Sympathetic / Parasympathetic Ratio (S/PS Ratio-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention, for 10 minutes.
description: S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
measure: Sympathetic / Parasympathetic Ratio (S/PS Ratio-b)
time frame: Evaluation during the intervention: For 20 minutes, while the interferential current (intervention) is being applied.s.
description: S/PS Ratio it's an indicator of autonomic nervous system balance. First Beat Bodyguard2 device will be used to collect S/PS Ratio.
measure: Numeric Pain Rating Scale (NPRS-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention.
description: NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
measure: Numeric Pain Rating Scale (NPRS-b)
time frame: Evaluation immediately after treatment session.
description: NPRS it's an scale used to measure with ease, patient's perceived pain with a scoring of 0 (no pain) and 10 (maximum pain).
measure: Roland Morris Questionnaire (RMQ-a)
time frame: Evaluation before intervention (basal): 15 minutes before intervention.
description: RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).
measure: Roland Morris Questionnaire (RMQ-b)
time frame: Evaluation immediately after treatment session.
description: RMQ it's a questionnaire used to measure an individual level of disability related to low back pain, with a scoring of 0 (no disability at all) and 24 (maximum disability).
measure: Scale for Personal Psychological Apprehension (SPPA)
time frame: Evaluation before intervention (basal): 15 minutes before intervention.
description: SPPA it's a questionnaire made to measure subject's susceptibility to receive electrical stimulation. A scoring of >45 points indicates that subject shouldnt be treated with electrical therapy.
measure: Dosimetry achieved with electrical stimulation
time frame: Recorded immediately after treatment session.
description: Maximal dosimetry reached during the session will be recorded in mA.
arm group label: Sham IFC therapy: Control group
arm group type: Sham Comparator
description: This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).
IFC parameters:
Carrier frequency of 4000 Hz
Amplitude modulated frequency of 65 Hz (AMF)
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
NO intensity (0 mA)
Session duration: 25 minutes
arm group label: IFC therapy: Experimental group
arm group type: Experimental
description: This group will recieve also instructions for core strengthening exercises and a single session of interferential current (IFC).
IFC parameters:
Carrier frequency of 4000 Hz
Amplitude modulated frequency of 65 Hz (AMF)
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
Intensity will depend on subjet's tolerance but without generating visible muscle twitches.
Session duration: 25 minutes
intervention type: Device
intervention name: Electrical stimulation: Interferential Current (IFC): Experimental Group
description: Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
Carrier frequency of 4000 Hz
Amplitude modulated frequency of 65 Hz (AMF)
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
Intensity will depend on subjet's tolerance but without generate visible muscle twitches.
Session duration: 25 minutes
arm group label: IFC therapy: Experimental group
intervention type: Device
intervention name: Electrical stimulation: Interferential Current (IFC): Control Group
description: Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
Carrier frequency of 4000 Hz
Amplitude modulated frequency of 65 Hz (AMF)
Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
NO intensity (0 mA)
Session duration: 25 minutes
arm group label: Sham IFC therapy: Control group
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Seville
investigator full name: Dr. Manuel Albornoz Cabello
investigator title: Doctor in Physiotherapy (PhD)
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Chronic Pain
sharing ipd: No