<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/NCT03755375</url>
  </required_header>
  <id_info>
    <org_study_id>61595016.0.0000.0068</org_study_id>
    <nct_id>NCT03755375</nct_id>
  </id_info>
  <brief_title>Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome</brief_title>
  <official_title>The Effects of Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</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>
      Related to urological and gynecological systems, patients with Bladdeer Pain Syndrome (BPS)&#xD;
      often present pain, pressure and chronic discomfort in suprapubic and perineal area&#xD;
      associated with low urinary tract symptoms. This condition can generates a negative impact in&#xD;
      cognitive, social, behavioral and sexual quality of life.&#xD;
&#xD;
      As Bladder Pain Syndrome originates from different causes and includes the genitourinary,&#xD;
      gastrointestinal, musculoskeletal and neuropsychological systems, a multidisciplinary&#xD;
      approach is needed with doctors,physiotherapists, psychologists and others. Physiotherapeutic&#xD;
      interventions are recommended as a conservative treatment for patients with BPS. The&#xD;
      physiotherapeutic interventions include the use of Biofeedback to relax the pelvic floor&#xD;
      muscles and manual therapy (myofascial trigger points release) to decrease muscle tension.&#xD;
      Transcutaneous electrostimulation (TENS) is used to decrease the pain and postural exercises&#xD;
      to improve the pelvic mobility. In this study, our hypothesis was that women with BPS&#xD;
      presented musculoskeletal dysfunction, and we tested a different physiotherapy approach that&#xD;
      was not being used. The reason for that understanding was the presence of refractory urinary&#xD;
      and pain symptoms notwithstanding the physiotherapy conventional treatment, such as manual&#xD;
      therapy and biofeedback. To test our hypothesis, we decided to add either TENS or postural&#xD;
      exercises to the conventional treatment. The objective of this study was to verify the&#xD;
      effects of biofeedback (BF) and manual therapy (MT) associated with transcutaneous electrical&#xD;
      nerve stimulation (TENS) or postural exercises (PE) in the treatment of bladder pain syndrome&#xD;
      (BPS) in women regarding pain and urinary symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the initial assessment, two specialized and trained physiotherapists applied a demographic&#xD;
      questionnaire to identify the characteristics of the sample and validated questionnaires of&#xD;
      perineal and suprapubic pain (Visual Analog Scale of Pain [VAS])(21) to quantify the pain;&#xD;
      urinary symptoms and problems (O'Leary-Sant - The Interstitial Cystitis Symptom and Problem&#xD;
      Index) (22) to evaluate the presence of urgency, frequency, nocturia and to quantify how much&#xD;
      these symptoms represent a problem to the patients, and the Female Sexual Function Index&#xD;
      (FSFI) (23) to evaluate the impact on sexual life. Then, a physical assessment by the&#xD;
      inspection and palpation of pelvic and perineal areas was made to identify myofascial trigger&#xD;
      points.&#xD;
&#xD;
      After the assessment, participants were blinded randomized by a mask researcher using&#xD;
      random.org and allocated into three groups of treatment (TENS, Postural and Conventional)&#xD;
      held over 10 sessions once a week. All participants needed to attend the whole treatment to&#xD;
      be included with a maximum delay of 2 weeks to start treatment. Conventional group was&#xD;
      treated with biofeedback for pelvic floor relaxation and manual therapy to release the&#xD;
      tension in the suprapubic, pelvic, and intravaginal areas. The manual therapy consisted of a&#xD;
      myofascial trigger point release maneuver using digital pressure and muscle fiber stretching&#xD;
      in pain areas. Biofeedback consisted of pelvic floor muscle coordination and relaxation&#xD;
      exercises using intravaginal probes. The training program was initiated with 10 fast&#xD;
      contractions with 5 seconds of relaxation between them followed by 10 sustained contractions&#xD;
      of 5 seconds with 10 seconds of relaxation between them. Finally, one minute of pelvic floor&#xD;
      relaxation was performed.&#xD;
&#xD;
      TENS group was treated with biofeedback, manual therapy, and transcutaneous&#xD;
      electrostimulation (TENS), a peripheral neuromodulation to promote analgesia in pain areas,&#xD;
      using two transcutaneous self-adhesive electrodes Axelgaard 5 cm x 5 cm with 2 cm of distance&#xD;
      between them. The parameters used were frequency = 100 Hz, pulse width = 50-100 µs, and&#xD;
      current intensity according to the patient's sensitivity.&#xD;
&#xD;
      Postural group was treated with biofeedback, manual therapy, and postural exercises , which&#xD;
      promoted pelvic mobility and functional training associated with respiratory exercises&#xD;
      increasing the diaphragmatic excursion. Postural exercises consisted of 10 repetitions of&#xD;
      breathing exercises in the lay-down position, 10 repetitions of hip anteversion and&#xD;
      retroversion in the sitting position, and 10 repetitions of hip anteversion, retroversion,&#xD;
      and lateral movement in the stand-up position.&#xD;
&#xD;
      The biofeedback and TENS device used was a Myotrac Infiniti T9800 (Thought Technology Ltda.,&#xD;
      Montreal, Canada, ISO 13485:2016ISO 13485:2016), a 2-channel system of surface&#xD;
      electromyography and electrostimulation using the Biograph Infiniti platform. For biofeedback&#xD;
      training, we used intravaginal electrodes St-Cloud/Femelex 6.9 cm.&#xD;
&#xD;
      All participants were evaluated post treatment and at 3 months of follow-up using the same&#xD;
      procedures of the initial assessment.&#xD;
&#xD;
      All participants were instructed to perform home training daily 3 times/day during treatment&#xD;
      and completed an exercise diary to demonstrate adherence to treatment. TENS and Conventional&#xD;
      groups were instructed to perform pelvic floor relaxation exercises, and Postural group was&#xD;
      instructed to perform pelvic floor relaxation exercises plus postural exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2018</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">December 19, 2019</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>Randomized control trial. All patients will be randomized by the computer (www.random.org) in 3 groups of treatment. Then, they were assessed by specialized physiotherapists through a medical history data; application of validated questionnaires of pain, urinary symptoms, sexual function and quality of life; pelvic floor muscles physical and surface electromyographic assessment. Patients were randomized to 3 different treatment groups, and treatment consisted by 10 sessions, once a week. TENS group was treated using Biofeedback , manual therapy and transcutaneous electrostimulation. Postural group was treated using Biofeedback , manual therapy and postural exercises. Conventional group was treated using Biofeedback and manual therapy. All participants were evaluated post treatment and at 3 months of follow-up using the same procedures of the initial assessment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>After the assessment, participants were blinded randomized by a mask researcher using random.org and allocated into three groups of treatment (TENS, Postural and Conventional) held over 10 sessions once a week.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain symptoms</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Change from Baseline in pain sympotms on the Visual Analog Scale after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary symptoms</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Change from Baseline in urinary symptoms on the O'Leary- Sant Urinary symptoms and problems score after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexual activity</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Change from Baseline in Female sexual function index score after treatment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Interstitial Cystitis</condition>
  <condition>Painful Bladder Syndrome</condition>
  <condition>Bladder Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>E-stim Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TENS group was treated with biofeedback, manual therapy, andtranscutaneous electrostimulation (TENS), a peripheral neuromodulation to promote analgesia in pain areas, using two transcutaneous self-adhesive electrodes Axelgaard 5 cm x 5 cm with 2 cm of distance between them. The parameters used were frequency = 100 Hz, pulse width = 50-100 µs, and current intensity according to the patient's sensitivity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postural Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Postural group was treated with biofeedback, manual therapy, and postural exercises , which promoted pelvic mobility and functional training associated with respiratory exercises increasing the diaphragmatic excursion.Postural exercises consisted of 10 repetitions of breathing exercises in the lay-down position, 10 repetitions of hip anteversion and retroversion in the sitting position, and 10 repetitions of hip anteversion, retroversion, and lateral movement in the stand-up position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional group was treated with biofeedback for pelvic floor relaxation and manual therapy to release the tension in the suprapubic, pelvic, and intravaginal areas. The manual therapy consisted of a myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas. Biofeedback consisted of pelvic floor muscle coordination and relaxation exercises using intravaginal probes. The training program was initiated with 10 fast contractions with 5 seconds of relaxation between them followed by 10 sustained contractions of 5 seconds with 10 seconds of relaxation between them. Finally, one minute of pelvic floor relaxation was performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>transcutaneous electrostimulation to improve the pain.</description>
    <arm_group_label>E-stim Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Postural exercises</intervention_name>
    <description>breathing exercises in the lay-down position, hip anteversion and retroversion in the sitting position, and anteversion, retroversion, and lateral movement in the stand-up position</description>
    <arm_group_label>Postural Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>pelvic floor muscle coordination and relaxation exercises using intravaginal probes</description>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_label>E-stim Group</arm_group_label>
    <arm_group_label>Postural Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Manual therapy</intervention_name>
    <description>myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas</description>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_label>E-stim Group</arm_group_label>
    <arm_group_label>Postural Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: women with a diagnosis of BPS according to NIH clinical criteria ≥ 18&#xD;
        years old, who presented symptoms of perineal and suprapubic pain, using painkillers,&#xD;
        anticholinergics, antidepressants, and anticonvulsants for at least 6 months, and exhibited&#xD;
        absence of urinary infection for at least 3 months for the initial assessment.&#xD;
&#xD;
        Exclusion criteria: women with positive uroculture, under actual or previous oncologic&#xD;
        treatment, with systemic or neurological diseases that could compromise pelvic structures,&#xD;
        with cognitive deficiency that compromised the understanding of the provided instructions&#xD;
        and those who refused to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clarice Tanaka, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Homero Bruschini, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
  </removed_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Clarice Tanaka</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Bladder pain syndrome</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Postural balance</keyword>
  <keyword>Manual therapy</keyword>
  <keyword>Biofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT03755375
org study id: 61595016.0.0000.0068
nct id: NCT03755375
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Related to urological and gynecological systems, patients with Bladdeer Pain Syndrome (BPS)
      often present pain, pressure and chronic discomfort in suprapubic and perineal area
      associated with low urinary tract symptoms. This condition can generates a negative impact in
      cognitive, social, behavioral and sexual quality of life.

      As Bladder Pain Syndrome originates from different causes and includes the genitourinary,
      gastrointestinal, musculoskeletal and neuropsychological systems, a multidisciplinary
      approach is needed with doctors,physiotherapists, psychologists and others. Physiotherapeutic
      interventions are recommended as a conservative treatment for patients with BPS. The
      physiotherapeutic interventions include the use of Biofeedback to relax the pelvic floor
      muscles and manual therapy (myofascial trigger points release) to decrease muscle tension.
      Transcutaneous electrostimulation (TENS) is used to decrease the pain and postural exercises
      to improve the pelvic mobility. In this study, our hypothesis was that women with BPS
      presented musculoskeletal dysfunction, and we tested a different physiotherapy approach that
      was not being used. The reason for that understanding was the presence of refractory urinary
      and pain symptoms notwithstanding the physiotherapy conventional treatment, such as manual
      therapy and biofeedback. To test our hypothesis, we decided to add either TENS or postural
      exercises to the conventional treatment. The objective of this study was to verify the
      effects of biofeedback (BF) and manual therapy (MT) associated with transcutaneous electrical
      nerve stimulation (TENS) or postural exercises (PE) in the treatment of bladder pain syndrome
      (BPS) in women regarding pain and urinary symptoms.
In the initial assessment, two specialized and trained physiotherapists applied a demographic
      questionnaire to identify the characteristics of the sample and validated questionnaires of
      perineal and suprapubic pain (Visual Analog Scale of Pain [VAS])(21) to quantify the pain;
      urinary symptoms and problems (O'Leary-Sant - The Interstitial Cystitis Symptom and Problem
      Index) (22) to evaluate the presence of urgency, frequency, nocturia and to quantify how much
      these symptoms represent a problem to the patients, and the Female Sexual Function Index
      (FSFI) (23) to evaluate the impact on sexual life. Then, a physical assessment by the
      inspection and palpation of pelvic and perineal areas was made to identify myofascial trigger
      points.

      After the assessment, participants were blinded randomized by a mask researcher using
      random.org and allocated into three groups of treatment (TENS, Postural and Conventional)
      held over 10 sessions once a week. All participants needed to attend the whole treatment to
      be included with a maximum delay of 2 weeks to start treatment. Conventional group was
      treated with biofeedback for pelvic floor relaxation and manual therapy to release the
      tension in the suprapubic, pelvic, and intravaginal areas. The manual therapy consisted of a
      myofascial trigger point release maneuver using digital pressure and muscle fiber stretching
      in pain areas. Biofeedback consisted of pelvic floor muscle coordination and relaxation
      exercises using intravaginal probes. The training program was initiated with 10 fast
      contractions with 5 seconds of relaxation between them followed by 10 sustained contractions
      of 5 seconds with 10 seconds of relaxation between them. Finally, one minute of pelvic floor
      relaxation was performed.

      TENS group was treated with biofeedback, manual therapy, and transcutaneous
      electrostimulation (TENS), a peripheral neuromodulation to promote analgesia in pain areas,
      using two transcutaneous self-adhesive electrodes Axelgaard 5 cm x 5 cm with 2 cm of distance
      between them. The parameters used were frequency = 100 Hz, pulse width = 50-100 µs, and
      current intensity according to the patient's sensitivity.

      Postural group was treated with biofeedback, manual therapy, and postural exercises , which
      promoted pelvic mobility and functional training associated with respiratory exercises
      increasing the diaphragmatic excursion. Postural exercises consisted of 10 repetitions of
      breathing exercises in the lay-down position, 10 repetitions of hip anteversion and
      retroversion in the sitting position, and 10 repetitions of hip anteversion, retroversion,
      and lateral movement in the stand-up position.

      The biofeedback and TENS device used was a Myotrac Infiniti T9800 (Thought Technology Ltda.,
      Montreal, Canada, ISO 13485:2016ISO 13485:2016), a 2-channel system of surface
      electromyography and electrostimulation using the Biograph Infiniti platform. For biofeedback
      training, we used intravaginal electrodes St-Cloud/Femelex 6.9 cm.

      All participants were evaluated post treatment and at 3 months of follow-up using the same
      procedures of the initial assessment.

      All participants were instructed to perform home training daily 3 times/day during treatment
      and completed an exercise diary to demonstrate adherence to treatment. TENS and Conventional
      groups were instructed to perform pelvic floor relaxation exercises, and Postural group was
      instructed to perform pelvic floor relaxation exercises plus postural exercises.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial. All patients will be randomized by the computer (www.random.org) in 3 groups of treatment. Then, they were assessed by specialized physiotherapists through a medical history data; application of validated questionnaires of pain, urinary symptoms, sexual function and quality of life; pelvic floor muscles physical and surface electromyographic assessment. Patients were randomized to 3 different treatment groups, and treatment consisted by 10 sessions, once a week. TENS group was treated using Biofeedback , manual therapy and transcutaneous electrostimulation. Postural group was treated using Biofeedback , manual therapy and postural exercises. Conventional group was treated using Biofeedback and manual therapy. All participants were evaluated post treatment and at 3 months of follow-up using the same procedures of the initial assessment.
primary purpose: Treatment
masking: Single (Participant)
masking description: After the assessment, participants were blinded randomized by a mask researcher using random.org and allocated into three groups of treatment (TENS, Postural and Conventional) held over 10 sessions once a week.
measure: Pain symptoms
time frame: up to 3 months
description: Change from Baseline in pain sympotms on the Visual Analog Scale after treatment
measure: Urinary symptoms
time frame: up to 3 months
description: Change from Baseline in urinary symptoms on the O'Leary- Sant Urinary symptoms and problems score after treatment
measure: Sexual activity
time frame: up to 3 months
description: Change from Baseline in Female sexual function index score after treatment
arm group label: E-stim Group
arm group type: Active Comparator
description: TENS group was treated with biofeedback, manual therapy, andtranscutaneous electrostimulation (TENS), a peripheral neuromodulation to promote analgesia in pain areas, using two transcutaneous self-adhesive electrodes Axelgaard 5 cm x 5 cm with 2 cm of distance between them. The parameters used were frequency = 100 Hz, pulse width = 50-100 µs, and current intensity according to the patient's sensitivity.
arm group label: Postural Group
arm group type: Active Comparator
description: Postural group was treated with biofeedback, manual therapy, and postural exercises , which promoted pelvic mobility and functional training associated with respiratory exercises increasing the diaphragmatic excursion.Postural exercises consisted of 10 repetitions of breathing exercises in the lay-down position, 10 repetitions of hip anteversion and retroversion in the sitting position, and 10 repetitions of hip anteversion, retroversion, and lateral movement in the stand-up position.
arm group label: Conventional Group
arm group type: Active Comparator
description: Conventional group was treated with biofeedback for pelvic floor relaxation and manual therapy to release the tension in the suprapubic, pelvic, and intravaginal areas. The manual therapy consisted of a myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas. Biofeedback consisted of pelvic floor muscle coordination and relaxation exercises using intravaginal probes. The training program was initiated with 10 fast contractions with 5 seconds of relaxation between them followed by 10 sustained contractions of 5 seconds with 10 seconds of relaxation between them. Finally, one minute of pelvic floor relaxation was performed.
intervention type: Device
intervention name: TENS
description: transcutaneous electrostimulation to improve the pain.
arm group label: E-stim Group
intervention type: Behavioral
intervention name: Postural exercises
description: breathing exercises in the lay-down position, hip anteversion and retroversion in the sitting position, and anteversion, retroversion, and lateral movement in the stand-up position
arm group label: Postural Group
intervention type: Device
intervention name: Biofeedback
description: pelvic floor muscle coordination and relaxation exercises using intravaginal probes
arm group label: Conventional Group
arm group label: E-stim Group
arm group label: Postural Group
intervention type: Behavioral
intervention name: Manual therapy
description: myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas
arm group label: Conventional Group
arm group label: E-stim Group
arm group label: Postural Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clarice Tanaka, PhD
role: Study Director
affiliation: University of Sao Paulo
last name: Homero Bruschini, PhD
role: Study Chair
affiliation: University of Sao Paulo
facility: 
country: Brazil
country: China
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Clarice Tanaka
investigator title: PhD
mesh term: Cystitis
mesh term: Cystitis, Interstitial
mesh term: Syndrome
mesh term: Somatoform Disorders