<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/NCT03227523</url>
  </required_header>
  <id_info>
    <org_study_id>010-17</org_study_id>
    <nct_id>NCT03227523</nct_id>
  </id_info>
  <brief_title>Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease: A Descriptive Observational Cross-Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Introduction. Nonspecific low back pain (NSLBP) is a very prevalent medical condition,&#xD;
      especially in subjects with chronic obstructive pulmonary disease (COPD).&#xD;
&#xD;
      The diaphragm is a respiratory muscle, but it takes part in trunk stabilization on lumbar&#xD;
      spine. NSLBP is related to lack of spinal control. The COPD symptoms include lack of&#xD;
      efficiency in diaphragm, which could be connected to NSLBP.&#xD;
&#xD;
      Hypothesis and objectives. COPD can contribute to NSLBP. It is associated with diaphragm&#xD;
      weakness, severity of respiratory function, lower level of physical activity and quality of&#xD;
      life in COPD.&#xD;
&#xD;
      Methods. A descriptive observational cross-sectional study was conducted with two groups: the&#xD;
      first one with subjects with COPD and the second one with subjects without it. Data were&#xD;
      collected on: pulmonary function; respiratory muscles strength; trunk postural control;&#xD;
      quality of life with COPD; physical activity level; lumbar pain presence, intensity and&#xD;
      disability. Data were collected in a single session.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction/Background. Nonspecific low back pain (NSLBP) is a very prevalent medical&#xD;
      condition (84% of the general population has suffered from it throughout its lifetime). Its&#xD;
      prevalence stands out in individuals with respiratory disease, especially in subjects with&#xD;
      chronic obstructive pulmonary disease (COPD).&#xD;
&#xD;
      Even if there are many theories that create a relationship between the two clinical&#xD;
      conditions (such as inflammation associated with smoking), the postural control one is quite&#xD;
      impressive.&#xD;
&#xD;
      The diaphragm is the main muscle of breathing with its inspiratory function, but it takes&#xD;
      part in trunk stabilization on lumbar spine. NSLBP is related to lack of spinal control. The&#xD;
      COPD symptoms include lack of efficiency in diaphragm (deformation, weakness and&#xD;
      fatigability), which could be connected to NSLBP.&#xD;
&#xD;
      Hypothesis and objectives. The starting hypothesis is that NSLBP is a result of an associated&#xD;
      pulmonary disease. COPD can contribute, correlate or even predispose them. NSLBP is&#xD;
      associated with diaphragm weakness, severity of respiratory function, COPD severity, lower&#xD;
      level of physical activity and quality of life in COPD.&#xD;
&#xD;
      Methods. A descriptive observational cross-sectional study was conducted with two groups: the&#xD;
      first one with 67 subjects, diagnosed with COPD, and the second one with 67 subjects without&#xD;
      pulmonary disease. Data were collected on: pulmonary function, spirometry; respiratory&#xD;
      muscles strength by measuring maximal inspiratory and expiratory pressures (MIP, MEP); trunk&#xD;
      postural control by motor control tests (KLAT, ASLR); quality of life with COPD, through the&#xD;
      COPD Assessment Test (CAT); physical activity level, using the Modified Baecke Physical&#xD;
      Activity Questionnaire (MBPAQ); pain localization, through a body map; pain intensity, using&#xD;
      Visual Analogue Scale (VAS) and disability, related to lumbar pain (if there is one), using&#xD;
      the Oswestry Disability Index (ODI).&#xD;
&#xD;
      The first group, with subjects diagnosed with COPD, was recruited in the hospital context,&#xD;
      while the second one, with subjects without lung disease, was recruited in and out of the&#xD;
      hospital context. Data were collected in a single session through tests for pulmonary&#xD;
      function, respiratory muscle strength and trunk postural control. They were also collected&#xD;
      using scales and questionnaires that measure the quality of life, physical activity level,&#xD;
      pain and disability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory muscle strength (MIP = maximum inspiratory pressure).</measure>
    <time_frame>1 day.</time_frame>
    <description>MIP in centimetres of water (cmH2O).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory muscle strength (MEP = maximum expitaroy pressure).</measure>
    <time_frame>1 day.</time_frame>
    <description>MEP in cmH2O.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postural control (Motor control test: KLAT = knee lift abdominal test).</measure>
    <time_frame>1 day.</time_frame>
    <description>KLAT in millimetres of mercury (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural control (Motor control test: ASLR = active straight leg raise).</measure>
    <time_frame>1 day.</time_frame>
    <description>ASLR in mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).</measure>
    <time_frame>1 day.</time_frame>
    <description>MBPAQ in n/47,56.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability related to low back pain (ODI = Oswestry Disability Index).</measure>
    <time_frame>1 day.</time_frame>
    <description>ODI in percetage (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of the pain (VAS = visual analogue scale).</measure>
    <time_frame>1 day.</time_frame>
    <description>VAS in n/100 millimetres (mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Fuction Testing in COPD (Spirometry: FEV1 = forced expiratiry volume in the first second; FVC = forced vital capacity; FEV1/FVC ratio).</measure>
    <time_frame>1 day.</time_frame>
    <description>FEV1 and FVC, measured in millilitres (mL) will be combinde to reporrt the ratio FEV1/FVC in percentage (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life in COPD (CAT = COPD Assessment Test).</measure>
    <time_frame>1 day.</time_frame>
    <description>CAT in n/40.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Demographic characteristics (age).</measure>
    <time_frame>1 day.</time_frame>
    <description>Age in years.</description>
  </other_outcome>
  <other_outcome>
    <measure>Demographic characteristics (gender).</measure>
    <time_frame>1 day.</time_frame>
    <description>Genders: masculine (M); femenine (F).</description>
  </other_outcome>
  <other_outcome>
    <measure>Anthropometric measurements (weight; height; BMI = body mass index).</measure>
    <time_frame>1 day.</time_frame>
    <description>Weight and height will be combined to report BMI in kilogrammes/square metres (kg/m2).</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>subjects with copd</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>subjects without pulmonary disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        According to the group, recruitment was or in the consultation of COPD of the University&#xD;
        Hospital Ramón y Cajal in Madrid (for subjects diagnosed with COPD) or outside the hospital&#xD;
        context (for subjects without lung disease).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participating voluntarily and signing the informed consent;&#xD;
&#xD;
          -  No exacerbations during the last 3 months, prior to the study (COPD group);&#xD;
&#xD;
          -  Being non-smokers during the last 10 years (not COPD group).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of disease that may affect the participation to the study (cardiovascular/&#xD;
             musculoskeletal/ neurological/ neurodegenerative disease);&#xD;
&#xD;
          -  Diagnosis of specific low back pain (lumbar surgery, infection, tumor, fracture,&#xD;
             structural deformity, inflammatory disorder, radicular syndrome or cauda equina&#xD;
             syndrome);&#xD;
&#xD;
          -  Performing a physical therapy program or having performed it in the last 3 months,&#xD;
             prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nicola Sante Diciolla, Physical Therapy</last_name>
    <phone>+34 695 069 558</phone>
    <email>nicola.s.diciolla@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alcalá</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28871</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Sante Diciolla</last_name>
      <phone>+34 695 069 558</phone>
      <email>nicola.s.diciolla@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Nicola Sante Diciolla</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>respiratory disorders</keyword>
  <keyword>pulmonary disease, chronic obstructive</keyword>
  <keyword>postural balance</keyword>
  <keyword>functional laterality</keyword>
  <keyword>diaphragm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT03227523
org study id: 010-17
nct id: NCT03227523
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction. Nonspecific low back pain (NSLBP) is a very prevalent medical condition,
      especially in subjects with chronic obstructive pulmonary disease (COPD).

      The diaphragm is a respiratory muscle, but it takes part in trunk stabilization on lumbar
      spine. NSLBP is related to lack of spinal control. The COPD symptoms include lack of
      efficiency in diaphragm, which could be connected to NSLBP.

      Hypothesis and objectives. COPD can contribute to NSLBP. It is associated with diaphragm
      weakness, severity of respiratory function, lower level of physical activity and quality of
      life in COPD.

      Methods. A descriptive observational cross-sectional study was conducted with two groups: the
      first one with subjects with COPD and the second one with subjects without it. Data were
      collected on: pulmonary function; respiratory muscles strength; trunk postural control;
      quality of life with COPD; physical activity level; lumbar pain presence, intensity and
      disability. Data were collected in a single session.
Introduction/Background. Nonspecific low back pain (NSLBP) is a very prevalent medical
      condition (84% of the general population has suffered from it throughout its lifetime). Its
      prevalence stands out in individuals with respiratory disease, especially in subjects with
      chronic obstructive pulmonary disease (COPD).

      Even if there are many theories that create a relationship between the two clinical
      conditions (such as inflammation associated with smoking), the postural control one is quite
      impressive.

      The diaphragm is the main muscle of breathing with its inspiratory function, but it takes
      part in trunk stabilization on lumbar spine. NSLBP is related to lack of spinal control. The
      COPD symptoms include lack of efficiency in diaphragm (deformation, weakness and
      fatigability), which could be connected to NSLBP.

      Hypothesis and objectives. The starting hypothesis is that NSLBP is a result of an associated
      pulmonary disease. COPD can contribute, correlate or even predispose them. NSLBP is
      associated with diaphragm weakness, severity of respiratory function, COPD severity, lower
      level of physical activity and quality of life in COPD.

      Methods. A descriptive observational cross-sectional study was conducted with two groups: the
      first one with 67 subjects, diagnosed with COPD, and the second one with 67 subjects without
      pulmonary disease. Data were collected on: pulmonary function, spirometry; respiratory
      muscles strength by measuring maximal inspiratory and expiratory pressures (MIP, MEP); trunk
      postural control by motor control tests (KLAT, ASLR); quality of life with COPD, through the
      COPD Assessment Test (CAT); physical activity level, using the Modified Baecke Physical
      Activity Questionnaire (MBPAQ); pain localization, through a body map; pain intensity, using
      Visual Analogue Scale (VAS) and disability, related to lumbar pain (if there is one), using
      the Oswestry Disability Index (ODI).

      The first group, with subjects diagnosed with COPD, was recruited in the hospital context,
      while the second one, with subjects without lung disease, was recruited in and out of the
      hospital context. Data were collected in a single session through tests for pulmonary
      function, respiratory muscle strength and trunk postural control. They were also collected
      using scales and questionnaires that measure the quality of life, physical activity level,
      pain and disability.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Respiratory muscle strength (MIP = maximum inspiratory pressure).
time frame: 1 day.
description: MIP in centimetres of water (cmH2O).
measure: Respiratory muscle strength (MEP = maximum expitaroy pressure).
time frame: 1 day.
description: MEP in cmH2O.
measure: Postural control (Motor control test: KLAT = knee lift abdominal test).
time frame: 1 day.
description: KLAT in millimetres of mercury (mmHg).
measure: Postural control (Motor control test: ASLR = active straight leg raise).
time frame: 1 day.
description: ASLR in mmHg.
measure: Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).
time frame: 1 day.
description: MBPAQ in n/47,56.
measure: Disability related to low back pain (ODI = Oswestry Disability Index).
time frame: 1 day.
description: ODI in percetage (%).
measure: Intensity of the pain (VAS = visual analogue scale).
time frame: 1 day.
description: VAS in n/100 millimetres (mm).
measure: Pulmonary Fuction Testing in COPD (Spirometry: FEV1 = forced expiratiry volume in the first second; FVC = forced vital capacity; FEV1/FVC ratio).
time frame: 1 day.
description: FEV1 and FVC, measured in millilitres (mL) will be combinde to reporrt the ratio FEV1/FVC in percentage (%).
measure: Quality of life in COPD (CAT = COPD Assessment Test).
time frame: 1 day.
description: CAT in n/40.
measure: Demographic characteristics (age).
time frame: 1 day.
description: Age in years.
measure: Demographic characteristics (gender).
time frame: 1 day.
description: Genders: masculine (M); femenine (F).
measure: Anthropometric measurements (weight; height; BMI = body mass index).
time frame: 1 day.
description: Weight and height will be combined to report BMI in kilogrammes/square metres (kg/m2).
arm group label: subjects with copd
arm group label: subjects without pulmonary disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicola Sante Diciolla, Physical Therapy
phone: +34 695 069 558
email: nicola.s.diciolla@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Nicola Sante Diciolla
investigator title: Physiotherapist
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Back Pain
mesh term: Low Back Pain