<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/NCT02205294</url>
  </required_header>
  <id_info>
    <org_study_id>REB ROMEO # 1017573</org_study_id>
    <nct_id>NCT02205294</nct_id>
  </id_info>
  <brief_title>Osteopathic Treatment and Deep Vein Thrombosis (DVT)</brief_title>
  <official_title>The Effect of Osteopathic Treatment in Acute Proximal Leg Deep Vein Thrombosis (DVT) to Reduce Pain and Swelling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteopathic treatment will provide:&#xD;
&#xD;
        1. A significant reduction of pain and swelling of the affected DVT leg&#xD;
&#xD;
        2. An increase in the quality of life (QOL) for individuals with DVT of the leg&#xD;
&#xD;
        3. Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thousands of individuals are affected by deep vein thrombosis (DVT) every year. Medical&#xD;
      treatment is aimed at preventing extension and recurrence of the blood clot (DVT) through the&#xD;
      use of anticoagulation medication. Compression stockings may be added for reduction of pain&#xD;
      and swelling, but this therapy remains controversial amongst physicians. To date, there is&#xD;
      limited manual therapies available for individuals affected with DVT. Regular medical&#xD;
      treatment, anticoagulation medication, along with osteopathic treatment may offer these&#xD;
      individuals improved control of the symptoms associated with DVT. In the long term&#xD;
      osteopathic treatment may provide an increase in the quality of life (QOL) and improve the&#xD;
      signs and symptoms associated with the post-thrombotic syndrome (PTS), which can be&#xD;
      burdensome for both the individual and the health care system. Offering an effective add on&#xD;
      treatment could provide individuals and the medical system with an additional means of&#xD;
      treatment for the symptoms of DVT and also for the prevention of development of PTS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2014</start_date>
  <completion_date type="Actual">April 4, 2019</completion_date>
  <primary_completion_date type="Actual">April 4, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Swelling</measure>
    <time_frame>1 month pre and post testing and 2 months</time_frame>
    <description>Swelling will be measured using a tension-controlled tape measure at the initial study visit, one month after diagnosis of the subject's DVT and then again at 2 months after diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leg Pain</measure>
    <time_frame>1 month pre and post testing and 2 months</time_frame>
    <description>Leg Pain will be measured using the visual analogue scale (VAS), at the initial study visit(1 month after diagnosis of the DVT) pre and post assessment or assessment plus treatment. Pain will be evaluated again at the 2 month visit post answering questionnaires and lying supine for 10 minutes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of LIfe (QOL)</measure>
    <time_frame>1 month and 2 months</time_frame>
    <description>Veines QOL/Sym Questionnaire will be completed by all participants at both study visits to determine if there have been any changes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment for Post Thrombotic Syndrome (PTS)</measure>
    <time_frame>1 month and 2 months</time_frame>
    <description>The Villalta scale will be used to assess subjects for signs and symptoms of the post-thrombotic syndrome at both study visits.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Deep Vein Thrombosis (DVT)</condition>
  <arm_group>
    <arm_group_label>Assessment Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will have an osteopathic assessment to determine areas of tension in specific areas of the body. These areas include: the thoracic diaphragm, the heart and pericardium, the iliac fascia, the femoral sheath, the sartorius muscle, the pelvic diaphragm and the interosseous membrane (IM) of the lower extremity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment and Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will have an osteopathic assessment to determine areas of tension in specific areas of the body. These areas of tension will receive osteopathic treatment, using myofascial release techniques. These areas include: the thoracic diaphragm, the heart and pericardium, the iliac fascia, the femoral sheath, the sartorius muscle, the pelvic diaphragm and the interosseous membrane (IM) of the lower extremity</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic Treatment</intervention_name>
    <description>The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.</description>
    <arm_group_label>Assessment and Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  first episode of symptomatic objectively confirmed proximal leg DVT without pulmonary&#xD;
             embolism&#xD;
&#xD;
          -  1 month of appropriate anticoagulation treatment&#xD;
&#xD;
          -  therapeutic level of anticoagulation (ie: Warfarin, INR- 2.0-3.0)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt; 1 month + 7 days of anticoagulation&#xD;
&#xD;
          -  history of previously confirmed proximal or distal leg DVT&#xD;
&#xD;
          -  medically unstable individuals requiring hospitalization&#xD;
&#xD;
          -  history of peripheral vascular disease (PVD)&#xD;
&#xD;
          -  injury of affected leg (trauma within the last 6 months or leg currently casted)&#xD;
&#xD;
          -  history of previous stroke&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  renal failure requiring hemodialysis or peritoneal dialysis&#xD;
&#xD;
          -  diagnosis of cancer in the last five years or currently receiving treatment for cancer&#xD;
&#xD;
          -  open heart or vascular surgery in the last year&#xD;
&#xD;
          -  any neurological condition (ie: MS, ALS, Parkinsons, etc)&#xD;
&#xD;
          -  currently pregnant&#xD;
&#xD;
          -  geographic inaccessibility&#xD;
&#xD;
          -  unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darlene D MacLeod, BscN DOMP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nova Scotia Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QEll Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteopathic treatment</keyword>
  <keyword>Deep Vein Thrombosis</keyword>
  <keyword>Proximal Leg DVT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Pending numbers recruited</ipd_description>
  </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/NCT02205294
org study id: REB ROMEO # 1017573
nct id: NCT02205294
lead sponsor: 
has dmc: Yes
Osteopathic treatment will provide:

        1. A significant reduction of pain and swelling of the affected DVT leg

        2. An increase in the quality of life (QOL) for individuals with DVT of the leg

        3. Improved signs and symptoms of the post thrombotic syndrome of the affected DVT leg
Thousands of individuals are affected by deep vein thrombosis (DVT) every year. Medical
      treatment is aimed at preventing extension and recurrence of the blood clot (DVT) through the
      use of anticoagulation medication. Compression stockings may be added for reduction of pain
      and swelling, but this therapy remains controversial amongst physicians. To date, there is
      limited manual therapies available for individuals affected with DVT. Regular medical
      treatment, anticoagulation medication, along with osteopathic treatment may offer these
      individuals improved control of the symptoms associated with DVT. In the long term
      osteopathic treatment may provide an increase in the quality of life (QOL) and improve the
      signs and symptoms associated with the post-thrombotic syndrome (PTS), which can be
      burdensome for both the individual and the health care system. Offering an effective add on
      treatment could provide individuals and the medical system with an additional means of
      treatment for the symptoms of DVT and also for the prevention of development of PTS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Swelling
time frame: 1 month pre and post testing and 2 months
description: Swelling will be measured using a tension-controlled tape measure at the initial study visit, one month after diagnosis of the subject's DVT and then again at 2 months after diagnosis.
measure: Leg Pain
time frame: 1 month pre and post testing and 2 months
description: Leg Pain will be measured using the visual analogue scale (VAS), at the initial study visit(1 month after diagnosis of the DVT) pre and post assessment or assessment plus treatment. Pain will be evaluated again at the 2 month visit post answering questionnaires and lying supine for 10 minutes.
measure: Quality of LIfe (QOL)
time frame: 1 month and 2 months
description: Veines QOL/Sym Questionnaire will be completed by all participants at both study visits to determine if there have been any changes.
measure: Assessment for Post Thrombotic Syndrome (PTS)
time frame: 1 month and 2 months
description: The Villalta scale will be used to assess subjects for signs and symptoms of the post-thrombotic syndrome at both study visits.
arm group label: Assessment Only
arm group type: No Intervention
description: Subjects will have an osteopathic assessment to determine areas of tension in specific areas of the body. These areas include: the thoracic diaphragm, the heart and pericardium, the iliac fascia, the femoral sheath, the sartorius muscle, the pelvic diaphragm and the interosseous membrane (IM) of the lower extremity
arm group label: Assessment and Treatment
arm group type: Active Comparator
description: Subjects will have an osteopathic assessment to determine areas of tension in specific areas of the body. These areas of tension will receive osteopathic treatment, using myofascial release techniques. These areas include: the thoracic diaphragm, the heart and pericardium, the iliac fascia, the femoral sheath, the sartorius muscle, the pelvic diaphragm and the interosseous membrane (IM) of the lower extremity
intervention type: Other
intervention name: Osteopathic Treatment
description: The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.
arm group label: Assessment and Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Darlene D MacLeod, BscN DOMP
role: Principal Investigator
affiliation: Nova Scotia Health Authority
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: Undecided
ipd description: Pending numbers recruited