<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/NCT03827486</url>
  </required_header>
  <id_info>
    <org_study_id>LUMBAREX</org_study_id>
    <nct_id>NCT03827486</nct_id>
  </id_info>
  <brief_title>EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL</brief_title>
  <acronym>LUMBAREX</acronym>
  <official_title>EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Carlos, Madrid</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>
      Introduction: Low back pain is a frequent and universally distributed symptom that affects&#xD;
      people of any age and both sexes. Approximately 80% of the population will present it at some&#xD;
      point in their life. Acute low back pain lasts less than 4 weeks, subacute 4 to 12 weeks and&#xD;
      chronic more than 12 weeks.&#xD;
&#xD;
      Hypothesis: Treatment with an exercise program combined with the usual treatment decreases&#xD;
      the recurrence of acute low back pain, as well as improvements in pain, functionality, and&#xD;
      quality of life of patients.&#xD;
&#xD;
      Principal Objective To evaluate the decrease of recurrence of low back pain in the&#xD;
      medium-long term of the patients who perform an exercise program compared to those who do&#xD;
      not, with both groups receiving the same pharmacological treatment and information of the&#xD;
      postural hygiene guidelines endorsed by the current scientific societies.&#xD;
&#xD;
      Methods: Patients between 18 and 65 years of age who come to the emergency room with acute&#xD;
      low back pain and who meet the eligibility criteria proposed for this study. At the first&#xD;
      visit, patients in a control group and intervention group will be randomized. Pharmacological&#xD;
      treatment and postural hygiene guidelines will be indicated for both groups, adding the&#xD;
      exercise table to the intervention group. The variables chosen are the questionnaires&#xD;
      Oswestry for functionality, Goldberg, EuroQol-5D for the quality of life, and VAS for pain;&#xD;
      which will be measured in the first consultation, at one month, at three and at six months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients who present a new process</measure>
    <time_frame>3 months</time_frame>
    <description>Patient who present a recurrence</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Domicilary exercise program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care (exercise)</intervention_name>
    <description>Exercise program according to the standard of care</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Domicilary exercise program</intervention_name>
    <description>Domicilary exercise program according to protocol (evidence based medicine)</description>
    <arm_group_label>Domicilary exercise program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 and 65 years old.&#xD;
&#xD;
          2. Low back pain of non-traumatic origin.&#xD;
&#xD;
          3. Signature of informed consent.&#xD;
&#xD;
          4. Availability for compliance with the intervention and commitment to send the study&#xD;
             questionnaires.&#xD;
&#xD;
          5. A correct domain of the Spanish language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women and breastfeeding&#xD;
&#xD;
          2. Any underlying pathology that contraindicates the use of the drugs (NSAIDs,&#xD;
             paracetamol) included in this study.&#xD;
&#xD;
          3. Rheumatological diseases that cause spinal involvement (e.g., spondyloarthritis)&#xD;
&#xD;
          4. Low back pain with clinical or associated neurological deficit&#xD;
&#xD;
          5. History of active cancer or remission less than one year&#xD;
&#xD;
          6. Pathological previous image test that shows a causal relationship with the episode&#xD;
             under study (e.g. fracture-vertebral crush, herniated disc, etc.)&#xD;
&#xD;
          7. Low back pain associated with other systemic pathologies (eg urinary infection,&#xD;
             retroperitoneal hematomas, pancreatitis, etc.)&#xD;
&#xD;
          8. Fever&#xD;
&#xD;
          9. Patients with usual analgesic treatment superior to the 1st step of WHO.&#xD;
&#xD;
         10. Major psychiatric pathology diagnosed not stable (pharmacological treatment not stable&#xD;
             in the last 6 months) except depression&#xD;
&#xD;
         11. Neuromuscular pathology diagnosed&#xD;
&#xD;
         12. Having some of the following diseases: fibromyalgia, chronic fatigue syndrome, chronic&#xD;
             low back pain diagnosed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rossana Chiesa Estomba, MD</last_name>
    <phone>+34913003000</phone>
    <email>chiero16@gmail.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Rossana Chiesa Estomba</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Recurrence</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/NCT03827486
org study id: LUMBAREX
nct id: NCT03827486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Low back pain is a frequent and universally distributed symptom that affects
      people of any age and both sexes. Approximately 80% of the population will present it at some
      point in their life. Acute low back pain lasts less than 4 weeks, subacute 4 to 12 weeks and
      chronic more than 12 weeks.

      Hypothesis: Treatment with an exercise program combined with the usual treatment decreases
      the recurrence of acute low back pain, as well as improvements in pain, functionality, and
      quality of life of patients.

      Principal Objective To evaluate the decrease of recurrence of low back pain in the
      medium-long term of the patients who perform an exercise program compared to those who do
      not, with both groups receiving the same pharmacological treatment and information of the
      postural hygiene guidelines endorsed by the current scientific societies.

      Methods: Patients between 18 and 65 years of age who come to the emergency room with acute
      low back pain and who meet the eligibility criteria proposed for this study. At the first
      visit, patients in a control group and intervention group will be randomized. Pharmacological
      treatment and postural hygiene guidelines will be indicated for both groups, adding the
      exercise table to the intervention group. The variables chosen are the questionnaires
      Oswestry for functionality, Goldberg, EuroQol-5D for the quality of life, and VAS for pain;
      which will be measured in the first consultation, at one month, at three and at six months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients who present a new process
time frame: 3 months
description: Patient who present a recurrence
arm group label: Standard of care
arm group type: Active Comparator
arm group label: Domicilary exercise program
arm group type: Experimental
intervention type: Other
intervention name: Standard of care (exercise)
description: Exercise program according to the standard of care
arm group label: Standard of care
intervention type: Other
intervention name: Domicilary exercise program
description: Domicilary exercise program according to protocol (evidence based medicine)
arm group label: Domicilary exercise program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rossana Chiesa Estomba, MD
phone: +34913003000
email: chiero16@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Rossana Chiesa Estomba
investigator title: MD
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Recurrence
sharing ipd: No