<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/NCT03797911</url>
  </required_header>
  <id_info>
    <org_study_id>RAP39426977</org_study_id>
    <nct_id>NCT03797911</nct_id>
  </id_info>
  <brief_title>Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT</brief_title>
  <official_title>Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAPbarcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RAPbarcelona</source>
  <oversight_info>
    <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 evaluates if the application of resistive capacitive monopolar radiofrequency&#xD;
      therapy associated with physiotherapeutic techniques and pain education provides benefits&#xD;
      with respect to physiotherapy and pain education techniques alone in the management of&#xD;
      patients with chronic pelvic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is evident that physiotherapeutic techniques and pain education are a first-line treatment&#xD;
      for patients suffering from chronic pelvic pain. But there is no scientific evidence that&#xD;
      resistive capacitive monopolar radiofrequency can be another treatment option for these&#xD;
      patients, although at the clinical level there is evidence of its beneficial effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2019</start_date>
  <completion_date type="Actual">April 23, 2021</completion_date>
  <primary_completion_date type="Actual">April 16, 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>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Triple blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain</measure>
    <time_frame>baseline and 10 weeks</time_frame>
    <description>The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention.&#xD;
The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means &quot;I have no pain&quot; and 10 means &quot;I have an unbearable pain&quot;.&#xD;
The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess quality of life</measure>
    <time_frame>baseline, 5 and 10 weeks</time_frame>
    <description>Asess the perceived quality of life of patients in the study according to the SF-12 questionnaire.&#xD;
The Short-Form 12 Health Survey was designed in 1994 with the aim that, through the self-completion of a brief questionnaire, the perception of physical and mental quality of life could be objectified in a simpler way than the original questionnaire SF -36. This simple questionnaire of 12 items representing the 8 dimensions of health was originally developed in English. It is a questionnaire that has proven to be valid and reliable to be used in clinical practice as an instrument to assess the quality of life. The 8 dimensions are the physical function (2 items), physical role (2 items), body pain (1 item), general health (1 item), vitality (1 item), social function (1 item), emotional role (2) items) and mental health (2 items). The result is two variables (physical and mental) that value quality in these two aspects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess kinesiophobia</measure>
    <time_frame>baseline, 5 and 10 weeks</time_frame>
    <description>Asess the kinesiophobia suffered by patients in the study according to the TSK-11 (Tampa Scale of Kinesiophobia) questionnaire.&#xD;
The Tampa Scale of Kinesiophobia (TSK-11), validated in Spanish, adequately captures the patient's movement capacity taking into account the perceived pain intensity in 11 questions. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess catastrophism</measure>
    <time_frame>baseline, 5 and 10 weeks</time_frame>
    <description>Asess the catastrophism suffered by patients in the study according to the Catastrophism scale.&#xD;
The Catastrophism Scale, also validated in Spanish, allows us to assess the catastrophic intensity of the disease, a more psychological aspect, but also very relevant in this chronic and disabling pathology. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment. It is a questionnaire of 20 questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the degree of adherence to treatment</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assess the degree of adherence to treatment (%) of the patients who are in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess number of participants with high adherence to treatment</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assess the number of patients (n) with high adherence who are in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess number of participants with adverse effects</measure>
    <time_frame>10 weeks</time_frame>
    <description>Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Pelvic Pain</condition>
  <condition>Pelvic Pain Syndrome</condition>
  <condition>Chronic Pain</condition>
  <condition>Chronic Pain Syndrome</condition>
  <condition>Chronic Pelvic Inflammatory Disease</condition>
  <condition>Physical Therapy</condition>
  <arm_group>
    <arm_group_label>active resistive capacitive monopolar radiofrequency</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): The intervention group will receive the treatment with activated resistive capacitive monopolar radiofrequency system, with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.&#xD;
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive resistive capacitive monopolar radiofrequency</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of the technique in the control group (inactivated resistive capacitive monopolar radiofrequency therapy): The control group will receive the treatment with inactivated resistive capacitive monopolar radiofrequency system (placebo), with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.&#xD;
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education</intervention_name>
    <description>Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.</description>
    <arm_group_label>active resistive capacitive monopolar radiofrequency</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education</intervention_name>
    <description>Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.</description>
    <arm_group_label>Inactive resistive capacitive monopolar radiofrequency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have an age equal to or greater than 18 years&#xD;
&#xD;
          -  Having chronic pelvic pain of six or more months of evolution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to grant informed consent.&#xD;
&#xD;
          -  Have fibromyalgia.&#xD;
&#xD;
          -  Present a pacemaker or other type of electronic implant.&#xD;
&#xD;
          -  Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic&#xD;
             conditions).&#xD;
&#xD;
          -  Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.&#xD;
&#xD;
          -  Suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple&#xD;
             sclerosis, myasthenia gravis or spinal muscular atrophy).&#xD;
&#xD;
          -  Have myelopathy and osteomyelitis.&#xD;
&#xD;
          -  Have neurological and / or metabolic pathology that alters the response capacity:&#xD;
             diabetes, parkinson's disease, senile dementia ...&#xD;
&#xD;
          -  Have an alteration of the central nervous system (traumatic or spinal vascular injury)&#xD;
&#xD;
          -  Suffer oncological processes with sacral involvement.&#xD;
&#xD;
          -  Have a severe mental disorder.&#xD;
&#xD;
          -  Have vulvodynia&#xD;
&#xD;
          -  Be pregnant.&#xD;
&#xD;
          -  Have undergone surgery in the last 3 months in the pelvic area.&#xD;
&#xD;
          -  Have hypersensitivity of the skin, hyposensitivity and / or rejection of manual&#xD;
             contact.&#xD;
&#xD;
          -  Inability to correctly complete the questionnaires or understand the study protocol.&#xD;
&#xD;
          -  Having initiated other pelvic physiotherapy treatments during the study intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Andrea Carralero Martinez</name>
      <address>
        <city>Barcelona</city>
        <zip>08004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>December 24, 2021</last_update_submitted>
  <last_update_submitted_qc>December 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RAPbarcelona</investigator_affiliation>
    <investigator_full_name>Andrea Carralero Martínez</investigator_full_name>
    <investigator_title>Physical therapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Inflammatory Disease</mesh_term>
    <mesh_term>Pelvic Infection</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT03797911
org study id: RAP39426977
nct id: NCT03797911
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates if the application of resistive capacitive monopolar radiofrequency
      therapy associated with physiotherapeutic techniques and pain education provides benefits
      with respect to physiotherapy and pain education techniques alone in the management of
      patients with chronic pelvic pain.
It is evident that physiotherapeutic techniques and pain education are a first-line treatment
      for patients suffering from chronic pelvic pain. But there is no scientific evidence that
      resistive capacitive monopolar radiofrequency can be another treatment option for these
      patients, although at the clinical level there is evidence of its beneficial effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Triple blind
measure: Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
time frame: baseline and 10 weeks
description: The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention.
The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means "I have no pain" and 10 means "I have an unbearable pain".
The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment.
measure: Assess quality of life
time frame: baseline, 5 and 10 weeks
description: Asess the perceived quality of life of patients in the study according to the SF-12 questionnaire.
The Short-Form 12 Health Survey was designed in 1994 with the aim that, through the self-completion of a brief questionnaire, the perception of physical and mental quality of life could be objectified in a simpler way than the original questionnaire SF -36. This simple questionnaire of 12 items representing the 8 dimensions of health was originally developed in English. It is a questionnaire that has proven to be valid and reliable to be used in clinical practice as an instrument to assess the quality of life. The 8 dimensions are the physical function (2 items), physical role (2 items), body pain (1 item), general health (1 item), vitality (1 item), social function (1 item), emotional role (2) items) and mental health (2 items). The result is two variables (physical and mental) that value quality in these two aspects.
measure: Assess kinesiophobia
time frame: baseline, 5 and 10 weeks
description: Asess the kinesiophobia suffered by patients in the study according to the TSK-11 (Tampa Scale of Kinesiophobia) questionnaire.
The Tampa Scale of Kinesiophobia (TSK-11), validated in Spanish, adequately captures the patient's movement capacity taking into account the perceived pain intensity in 11 questions. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment.
measure: Assess catastrophism
time frame: baseline, 5 and 10 weeks
description: Asess the catastrophism suffered by patients in the study according to the Catastrophism scale.
The Catastrophism Scale, also validated in Spanish, allows us to assess the catastrophic intensity of the disease, a more psychological aspect, but also very relevant in this chronic and disabling pathology. It is a tool that allows assessing the severity of the disease, as well as the improvement that is obtained with the treatment. It is a questionnaire of 20 questions.
measure: Assess the degree of adherence to treatment
time frame: 10 weeks
description: Assess the degree of adherence to treatment (%) of the patients who are in this study.
measure: Assess number of participants with high adherence to treatment
time frame: 10 weeks
description: Assess the number of patients (n) with high adherence who are in this study.
measure: Assess number of participants with adverse effects
time frame: 10 weeks
description: Evaluate and identify the number of participants (n) who have an adverse effect during the study intervention.
arm group label: active resistive capacitive monopolar radiofrequency
arm group type: Experimental
description: Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): The intervention group will receive the treatment with activated resistive capacitive monopolar radiofrequency system, with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy.
arm group label: Inactive resistive capacitive monopolar radiofrequency
arm group type: Placebo Comparator
description: Application of the technique in the control group (inactivated resistive capacitive monopolar radiofrequency therapy): The control group will receive the treatment with inactivated resistive capacitive monopolar radiofrequency system (placebo), with the resistive electrode at the minimum intensity, together with the techniques of conventional physiotherapy treatment (trigger point treatment and myofascial techniques according to the location of pain) and pain education.
The patient will be stretched on the stretcher and the session will last 45 minutes, once a week, for 10 sessions. Ass baseline, after half therapy and after 10 weeks therapy.
intervention type: Combination Product
intervention name: Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
description: Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
arm group label: active resistive capacitive monopolar radiofrequency
intervention type: Combination Product
intervention name: Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
description: Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
arm group label: Inactive resistive capacitive monopolar radiofrequency
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: RAPbarcelona
investigator full name: Andrea Carralero Martínez
investigator title: Physical therapist
mesh term: Pelvic Inflammatory Disease
mesh term: Pelvic Infection
mesh term: Syndrome
mesh term: Chronic Pain
mesh term: Pelvic Pain
mesh term: Somatoform Disorders
sharing ipd: No