<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/NCT03299114</url>
  </required_header>
  <id_info>
    <org_study_id>30112015-6</org_study_id>
    <nct_id>NCT03299114</nct_id>
  </id_info>
  <brief_title>WHIRLPOOL FOR OSTEOARHRITIS</brief_title>
  <official_title>THE EFFECTIVENESS OF WHIRLPOOL FOR PATIENTS WITH NEUROPATHIC PAIN DUE TO KNEE OSTEOARTHRITIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ufuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ufuk University</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>
      Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims:&#xD;
      The aim of this study was to determine the efficacy of warm whirlpool on pain, disability,&#xD;
      quality of life (QoL) and sleep for patients with neuropathic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whirlpool treatment method is used for medical and surgical conditions. In literature there&#xD;
      are studies which recommend whirlpool therapy as a treatment for reducing pain in patients&#xD;
      with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on&#xD;
      pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analogue scale</measure>
    <time_frame>one month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 Health Survey</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DN4</measure>
    <time_frame>one month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Neuropathic Pain</condition>
  <condition>Osteo Arthritis Knee</condition>
  <condition>Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with warm whirlpool</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treated with sham whirlpool</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whirlpool</intervention_name>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suffering from knee pain at least 3 months&#xD;
&#xD;
          -  radiological manifestations considering were consistent with grade 3 and 4 knee OA due&#xD;
             to Kellgren and Lawrence criteria had DN4 scores ≥4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lower extremity surgery history, knee infection inflammatory disease like rheumatoid&#xD;
             arthritis back or pelvic pain related with knee pain another cause of polyneuropathy&#xD;
             (diabetes mellitus, vitamin B 12 deficiency, toxic or neurological disease like&#xD;
             stroke, spinal cord injury) lumbar disc herniation malignancy or active systemic&#xD;
             disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ufuk University</name>
      <address>
        <city>Ankara</city>
        <zip>06520</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ufuk University</investigator_affiliation>
    <investigator_full_name>ASLIHAN UZUNKULAOGLU</investigator_full_name>
    <investigator_title>Ufuk University</investigator_title>
  </responsible_party>
  <keyword>Neuropathic Pain</keyword>
  <keyword>Whirlpool</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Sleep Wake Disorders</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/NCT03299114
org study id: 30112015-6
nct id: NCT03299114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims:
      The aim of this study was to determine the efficacy of warm whirlpool on pain, disability,
      quality of life (QoL) and sleep for patients with neuropathic pain.
Whirlpool treatment method is used for medical and surgical conditions. In literature there
      are studies which recommend whirlpool therapy as a treatment for reducing pain in patients
      with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on
      pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: visual analogue scale
time frame: one month
measure: Short Form-36 Health Survey
time frame: one month
measure: Western Ontario and McMaster Universities Osteoarthritis Index
time frame: one month
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: one month
measure: DN4
time frame: one month
arm group label: Intervention Group
arm group type: Active Comparator
description: Treated with warm whirlpool
arm group label: Placebo group
arm group type: Placebo Comparator
description: Treated with sham whirlpool
intervention type: Other
intervention name: Whirlpool
arm group label: Intervention Group
arm group label: Placebo group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ufuk University
investigator full name: ASLIHAN UZUNKULAOGLU
investigator title: Ufuk University
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Neuralgia
mesh term: Sleep Wake Disorders
sharing ipd: No