<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/NCT03826511</url>
  </required_header>
  <id_info>
    <org_study_id>PetzCTH</org_study_id>
    <nct_id>NCT03826511</nct_id>
  </id_info>
  <brief_title>The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis</brief_title>
  <official_title>The Effects of Tiszasüly and Kolop Mud-pack Therapy in Knee Osteoarthritis: Randomized Non-inferiority Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Petz Aladar County Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Petz Aladar County Teaching Hospital</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>
      In this double-blind, randomized, follow-up study investigators evaluated and compared the&#xD;
      effects of Tiszasüly and Kolop mud-pack therapy on pain, function and quality of life in&#xD;
      patients with knee osteoarthritis. 30 patients were treated with Tiszasüly hot mud-pack&#xD;
      (Group 1), 30 patients with Kolop hot mud-pack (Group 2) for 10 working days. Knee pain,&#xD;
      function a nd qualitiy of life were measured at baseline, at the end of treatment and 3&#xD;
      months later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly&#xD;
      and Kolop mud-pack therapy on pain, function and quality of life in patients with knee&#xD;
      osteoarthritis.&#xD;
&#xD;
      Methods: In this double-blind, randomized, follow-up study 60 patients with knee&#xD;
      osteoarthritis were treated with either Tiszasüly hot mud-pack (Group 1), or with Kolop hot&#xD;
      mud-pack (Group 2) on 10 occasions for 2 weeks (10 working days). 100 mm Visual Analogue&#xD;
      Scale (VAS) for knee pain, Western Ontario and McMaster Universities Arthritis Index (WOMAC),&#xD;
      Knee Injury and Osteoarthritis Outcome Score (KOOS), Lequesne Index for physical function and&#xD;
      EuroQoL-5D for quality-of-life measure were recorded at baseline, at the end of treatment&#xD;
      (Week 2) and 3 months later (Week 12).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in severity of pain at rest</measure>
    <time_frame>Week 0 and Week 2</time_frame>
    <description>change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in severity of pain at rest</measure>
    <time_frame>Week 0 and Week 12</time_frame>
    <description>change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in function</measure>
    <time_frame>Week 0 and Week 2</time_frame>
    <description>change from baseline physical function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 2. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in function</measure>
    <time_frame>Week 0 and Week 12</time_frame>
    <description>change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in function</measure>
    <time_frame>Week 0 and Week 2</time_frame>
    <description>change from baseline physical function measuredf by Lequesne Index, which is a 10-question survey. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in function</measure>
    <time_frame>Week 0 and Week 12</time_frame>
    <description>change from baseline physical function measured by Lequesne Index, which is a 10-question survey. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in function</measure>
    <time_frame>Week 0 and Week 2</time_frame>
    <description>change from baselilne physical function measured by Knee Injury and Osteoarthritis Outcome Score (KOOS). It is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in knee osteoarthritis. It has five separately scored subscales: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in function</measure>
    <time_frame>Week 0 and Week 12</time_frame>
    <description>change from baselilne physical function measured by Knee Injury and Osteoarthritis Outcome Score (KOOS). It is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in knee osteoarthritis. It has five separately scored subscales: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>Week 0 and Week 2</time_frame>
    <description>change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>Week 0 and Week 12</time_frame>
    <description>change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Tiszasüly mud-pack</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Tiszasüly mud-pack group got hot mud-packs for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kolop mud-pack</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the Kolop mud-pack group got hot mud-packs for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tiszasüly hot mud-pack therapy</intervention_name>
    <description>Patients received Tiszasüly hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.</description>
    <arm_group_label>Tiszasüly mud-pack</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kolop mud-pack</intervention_name>
    <description>Patients received Kolop hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.</description>
    <arm_group_label>Kolop mud-pack</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years of age with knee osteoarthritis (radiologically&#xD;
             Kellgren-Laurence II-III. stage)&#xD;
&#xD;
          -  resting VAS pain is &gt; 50 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  fever&#xD;
&#xD;
          -  tumour&#xD;
&#xD;
          -  neurologic disorders with numbness and tingling sensation in the lower extremeties&#xD;
&#xD;
          -  skin disease aroud the knee&#xD;
&#xD;
          -  untreated hypertension&#xD;
&#xD;
          -  heart failure (NYHA II-IV. stage)&#xD;
&#xD;
          -  inflammatory rheumatic diseases&#xD;
&#xD;
          -  knee arthroplasty&#xD;
&#xD;
          -  steroid or hialuronic acid injection into the knee joint within 3 months&#xD;
&#xD;
          -  physiotherapy of the knee within 3 months&#xD;
&#xD;
          -  inflammatory knee osteoarthitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Petz Aladár County Teaching Hospital</name>
      <address>
        <city>Győr</city>
        <zip>9025</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 30, 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 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Petz Aladar County Teaching Hospital</investigator_affiliation>
    <investigator_full_name>Márta Király</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <keyword>mud-pack therapy</keyword>
  <keyword>osteoarthritis of the knee</keyword>
  <keyword>hot-pack therapy</keyword>
  <keyword>non-inferiority study</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>
  </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/NCT03826511
org study id: PetzCTH
nct id: NCT03826511
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this double-blind, randomized, follow-up study investigators evaluated and compared the
      effects of Tiszasüly and Kolop mud-pack therapy on pain, function and quality of life in
      patients with knee osteoarthritis. 30 patients were treated with Tiszasüly hot mud-pack
      (Group 1), 30 patients with Kolop hot mud-pack (Group 2) for 10 working days. Knee pain,
      function a nd qualitiy of life were measured at baseline, at the end of treatment and 3
      months later.
The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly
      and Kolop mud-pack therapy on pain, function and quality of life in patients with knee
      osteoarthritis.

      Methods: In this double-blind, randomized, follow-up study 60 patients with knee
      osteoarthritis were treated with either Tiszasüly hot mud-pack (Group 1), or with Kolop hot
      mud-pack (Group 2) on 10 occasions for 2 weeks (10 working days). 100 mm Visual Analogue
      Scale (VAS) for knee pain, Western Ontario and McMaster Universities Arthritis Index (WOMAC),
      Knee Injury and Osteoarthritis Outcome Score (KOOS), Lequesne Index for physical function and
      EuroQoL-5D for quality-of-life measure were recorded at baseline, at the end of treatment
      (Week 2) and 3 months later (Week 12).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: change in severity of pain at rest
time frame: Week 0 and Week 2
description: change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
measure: change in severity of pain at rest
time frame: Week 0 and Week 12
description: change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
measure: change in function
time frame: Week 0 and Week 2
description: change from baseline physical function measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 2. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
measure: change in function
time frame: Week 0 and Week 12
description: change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
measure: change in function
time frame: Week 0 and Week 2
description: change from baseline physical function measuredf by Lequesne Index, which is a 10-question survey. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living.
measure: change in function
time frame: Week 0 and Week 12
description: change from baseline physical function measured by Lequesne Index, which is a 10-question survey. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living.
measure: change in function
time frame: Week 0 and Week 2
description: change from baselilne physical function measured by Knee Injury and Osteoarthritis Outcome Score (KOOS). It is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in knee osteoarthritis. It has five separately scored subscales: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
measure: change in function
time frame: Week 0 and Week 12
description: change from baselilne physical function measured by Knee Injury and Osteoarthritis Outcome Score (KOOS). It is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in knee osteoarthritis. It has five separately scored subscales: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
measure: change in quality of life
time frame: Week 0 and Week 2
description: change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status).
measure: change in quality of life
time frame: Week 0 and Week 12
description: change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status).
arm group label: Tiszasüly mud-pack
arm group type: Active Comparator
description: Patients in the Tiszasüly mud-pack group got hot mud-packs for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
arm group label: Kolop mud-pack
arm group type: Active Comparator
description: Patients in the Kolop mud-pack group got hot mud-packs for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
intervention type: Other
intervention name: Tiszasüly hot mud-pack therapy
description: Patients received Tiszasüly hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
arm group label: Tiszasüly mud-pack
intervention type: Other
intervention name: Kolop mud-pack
description: Patients received Kolop hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
arm group label: Kolop mud-pack
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Petz Aladar County Teaching Hospital
investigator full name: Márta Király
investigator title: chief physician
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee