<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/NCT01710683</url>
  </required_header>
  <id_info>
    <org_study_id>ON-07-006</org_study_id>
    <nct_id>NCT01710683</nct_id>
  </id_info>
  <brief_title>Early Mobilisation Following Discectomy</brief_title>
  <official_title>Early Mobilisation Following Discectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern Orthopaedic Division, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen University Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northern Orthopaedic Division, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After lumbar discectomy 1st postoperative day high intensity exercise training reduced&#xD;
      hospital stay, pain and sick leave without side effects in the two year follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain is a major cause of delayed convalescence after discectomy. Different&#xD;
      analgesic treatments with the use of local analgesics and steroid can reduce the immediate&#xD;
      postoperative pain and convalescence after surgery. In orthopaedic and abdominal surgery&#xD;
      accelerated stay programs with early mobilisation have reduced pain in the early&#xD;
      postoperative periode. The late convalescence after discectomy for herniated disc disease can&#xD;
      be reduced with the use of epidural steroids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants were enrolled.&#xD;
  </why_stopped>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Reduced Hospital Stay Without Complication</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Median age 45 years, 18-63.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <description>Median age 46 years, 18-62.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care program</intervention_name>
    <description>Care program with multimodal pain treatment including epidural steroid</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>No other names.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care program</intervention_name>
    <description>Care program with multimodal pain treatment including epidural steroid.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>No other names.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with primary lumbar herniated disc disease who have received and performed a&#xD;
             standardized conservative treatment program with intensive exercises.&#xD;
&#xD;
          -  Oral and written acceptance.&#xD;
&#xD;
          -  Age 18 and above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with central or lateral spinal stenosis due to spondylosis or disc&#xD;
             degeneration who needed bilateral decompression, laminectomy or fusion.&#xD;
&#xD;
          -  Patients with cauda equina syndrome who needed acute operative treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sten Rasmussen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northern Orthopaedic Department, Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David S. Krum-Moeller, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Orthopaedic Surgery, Vejle and Give Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lene R. Lauridsen, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Orthopaedic Surgery, Vejle and Give Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henrik Kehlet, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northern Orthopaedic Division, Aalborg Hospital, Aarhus University</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Discectomy</keyword>
  <keyword>1st postoperative day</keyword>
  <keyword>Intensive exercise training</keyword>
  <keyword>Randomized controlled trial</keyword>
  <!-- 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/NCT01710683
org study id: ON-07-006
nct id: NCT01710683
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
After lumbar discectomy 1st postoperative day high intensity exercise training reduced
      hospital stay, pain and sick leave without side effects in the two year follow-up period.
Postoperative pain is a major cause of delayed convalescence after discectomy. Different
      analgesic treatments with the use of local analgesics and steroid can reduce the immediate
      postoperative pain and convalescence after surgery. In orthopaedic and abdominal surgery
      accelerated stay programs with early mobilisation have reduced pain in the early
      postoperative periode. The late convalescence after discectomy for herniated disc disease can
      be reduced with the use of epidural steroids.
observational model: Cohort
time perspective: Retrospective
arm group label: Control group
description: Median age 45 years, 18-63.
arm group label: Intervention group
description: Median age 46 years, 18-62.
intervention type: Behavioral
intervention name: Care program
description: Care program with multimodal pain treatment including epidural steroid
arm group label: Control group
other name: No other names.
intervention type: Behavioral
intervention name: Care program
description: Care program with multimodal pain treatment including epidural steroid.
arm group label: Intervention group
other name: No other names.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sten Rasmussen, M.D.
role: Principal Investigator
affiliation: Northern Orthopaedic Department, Aalborg University Hospital, Denmark
last name: David S. Krum-Moeller, M.D.
role: Study Chair
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
last name: Lene R. Lauridsen, M.D.
role: Study Chair
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
last name: Henrik Kehlet, M.D.
role: Study Chair
affiliation: Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen
facility: 
country: Denmark
responsible party type: Sponsor