<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/NCT03274128</url>
  </required_header>
  <id_info>
    <org_study_id>KLASTER - 3/2014</org_study_id>
    <nct_id>NCT03274128</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness of Spa Treatment in Swieradow Zdroj With Special Regard to the Action of Radon Waters</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wroclaw Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wroclaw Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Observation conducted during the 21 days of treatment in the health resort of&#xD;
      Swieradow-Zdroj. In a treatment of applied therapy: radon therapeutic baths and inhalations,&#xD;
      kinesiotherapy. Study group with degenerative joints and disc disease participating in&#xD;
      therapy. The control group was selected by the spa workers, also suffering from a&#xD;
      degenerative disease of the movement organs not using the spa's treatment base. In both of&#xD;
      these groups, appropriate pre- and post-treatment studies were performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The observation was conducted during 21 days of medicinal stays in the health resort of&#xD;
      Swieradow-Zdroj. The treatment included a comprehensive therapy: radon therapeutic baths and&#xD;
      inhalations, kinesiotherapy.&#xD;
&#xD;
      The study group consisted of patients with degenerative joints and disc disease participating&#xD;
      in therapy. On the day of admission to the SPA the patients were subjected to subjective and&#xD;
      objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS-&#xD;
      total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5&#xD;
      and after 18 days. In addition, before and after treatment, standard scales were used to&#xD;
      assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS&#xD;
      scale.&#xD;
&#xD;
      The control group was selected by the spa workers, also suffering from a degenerative disease&#xD;
      of the movement organs not using the spa's treatment base. In this group also made the same&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2015</start_date>
  <completion_date type="Actual">March 30, 2016</completion_date>
  <primary_completion_date type="Actual">April 30, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of results Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) on day 5 and after 18 days of therapy</measure>
    <time_frame>on day 5 and after 18 days of therapy</time_frame>
    <description>The biological material was taken with sterile disposable equipment. After 10 ml of venous blood was collected in a closed system, local laboratory tests were performed, such as morphology with smear, CRP, glycemic control, and lipids profile. Tested using standard tests. Subsequently, 5 ml of venous blood also collected in the closed system directly into the monoveta was centrifuged to obtain serum - a sample to be tested for TAS. Another 5 ml of venous blood collected in the closed system will be left to solidify - sample for metalloproteinase 8. Both specimens were transported at +6 ° C. Analyzes carried out by non-standard and non-commercial laboratory tests serving exclusively for scientific research in the Department of Medical Analyzes of the Medical University of Wroclaw.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Index</measure>
    <time_frame>on day 5 and after 18 days</time_frame>
    <description>MCGill scale (The McGill Pain Questionnaire) It is a scale of rating pain developed at McGill University by Melzack and Torgerson in 1971. It is a self-report questionnaire that allows individuals to give their doctor a good description of the quality and intensity of pain that they are experiencing. Users first select a single word from each group that best reflects their pain. Users then review the list and select the three words from groups 1-10 that best describe their pain, two words from groups 11-15, a single word from group 16, and then one word from groups 17-20. After completing the questionnaire, users will have selected seven words that best describe their pain. Users can use some words more than once.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Index</measure>
    <time_frame>on day 5 and after 18 days</time_frame>
    <description>VAS scale (The visual analogue scale) It is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. This continuous (or &quot;analogue&quot;) aspect of the scale differentiates it from discrete scales such as the Likert scale. There is evidence showing that visual analogue scales have superior metrical characteristics than discrete scales, thus a wider range of statistical methods can be applied to the measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression Index</measure>
    <time_frame>on day 5 and after 18 days</time_frame>
    <description>HADS scale (Hospital Anxiety and Depression Scale) It was originally developed by Zigmond and Snaith (1983)and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Zigmond and Snaith created this outcome measure specifically to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. This, it was hoped, would create a tool for the detection of anxiety and depression in people with physical health problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Degenerative Disc Disease</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment included a comprehensive therapy: radon therapeutic baths and inhalations, kinesiotherapy. On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS scale.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radon therapeutic baths and inhalations</intervention_name>
    <description>The natural water with low mineralized content plays a major therapeutic role with the parameters of Rn 303,1-441,5 Bq/l. In the treatment rooms (inhalation, cabins with baths and swimming pool) measurement of alpha radiation was 184,4-450,0 MeV. The measurements were analyzed every 3 months at the Institute of Occupational Medicine in the Department of Radiation Protection in Lodz, Poland. Among the types of treatments used in the therapy there was: comprehensive radon bath - with the temperature of 37 °C, duration 15 min., the treatments were performed every 2nd day, whereas radon inhalations lasted 15 min. with the temp. 37 °C- treatments were performed every 2nd day from Monday to Friday. Baths and inhalations were performed interchangeably and the total number of radon treatments during one stay was 15.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Kinesiotherapy</intervention_name>
    <description>It is the therapeutic treatment of disease by passive and active muscular movements (as by massage) and of exercise. It is the core element of physiotherapy/physical therapy. Kinesiotherapy - duration of 30-45 min,</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of degenerative joints and/or disc disease;&#xD;
&#xD;
          -  age range 40-60 years;&#xD;
&#xD;
          -  the written consent to participate in research;&#xD;
&#xD;
          -  no impediment to comprehensive treatment at the spa.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the lack of consent to participate in research;&#xD;
&#xD;
          -  the age under 40 and over 60 years;&#xD;
&#xD;
          -  the presence of diseases constituting a contraindication to therapy (compatible with&#xD;
             the standard list of indications and contraindications to spa therapy);&#xD;
&#xD;
          -  the presence of metabolic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jadwiga Kuciel-Lewandowska, MD</last_name>
    <role>Study Director</role>
    <affiliation>MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw</affiliation>
  </overall_official>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wroclaw Medical University</investigator_affiliation>
    <investigator_full_name>Jadwiga Kuciel-Lewandowska</investigator_full_name>
    <investigator_title>Doctor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Any request to share the IPD will be considered individually and in the group of all researchers who have participated in the research. Due to the law at the Medical University of Wroclaw every interested IPD of our study must also write a request to the Deputy Dean for the University of Medicine in Wroclaw to obtain access to such documents from him. The applicant will receive all contact details for the Deputy Dean for the University of Medical in Wroclaw when applying for access to the IPD.</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/NCT03274128
org study id: KLASTER - 3/2014
nct id: NCT03274128
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Observation conducted during the 21 days of treatment in the health resort of
      Swieradow-Zdroj. In a treatment of applied therapy: radon therapeutic baths and inhalations,
      kinesiotherapy. Study group with degenerative joints and disc disease participating in
      therapy. The control group was selected by the spa workers, also suffering from a
      degenerative disease of the movement organs not using the spa's treatment base. In both of
      these groups, appropriate pre- and post-treatment studies were performed.
The observation was conducted during 21 days of medicinal stays in the health resort of
      Swieradow-Zdroj. The treatment included a comprehensive therapy: radon therapeutic baths and
      inhalations, kinesiotherapy.

      The study group consisted of patients with degenerative joints and disc disease participating
      in therapy. On the day of admission to the SPA the patients were subjected to subjective and
      objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS-
      total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5
      and after 18 days. In addition, before and after treatment, standard scales were used to
      assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS
      scale.

      The control group was selected by the spa workers, also suffering from a degenerative disease
      of the movement organs not using the spa's treatment base. In this group also made the same
      study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of results Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) on day 5 and after 18 days of therapy
time frame: on day 5 and after 18 days of therapy
description: The biological material was taken with sterile disposable equipment. After 10 ml of venous blood was collected in a closed system, local laboratory tests were performed, such as morphology with smear, CRP, glycemic control, and lipids profile. Tested using standard tests. Subsequently, 5 ml of venous blood also collected in the closed system directly into the monoveta was centrifuged to obtain serum - a sample to be tested for TAS. Another 5 ml of venous blood collected in the closed system will be left to solidify - sample for metalloproteinase 8. Both specimens were transported at +6 ° C. Analyzes carried out by non-standard and non-commercial laboratory tests serving exclusively for scientific research in the Department of Medical Analyzes of the Medical University of Wroclaw.
measure: Pain Index
time frame: on day 5 and after 18 days
description: MCGill scale (The McGill Pain Questionnaire) It is a scale of rating pain developed at McGill University by Melzack and Torgerson in 1971. It is a self-report questionnaire that allows individuals to give their doctor a good description of the quality and intensity of pain that they are experiencing. Users first select a single word from each group that best reflects their pain. Users then review the list and select the three words from groups 1-10 that best describe their pain, two words from groups 11-15, a single word from group 16, and then one word from groups 17-20. After completing the questionnaire, users will have selected seven words that best describe their pain. Users can use some words more than once.
measure: Pain Index
time frame: on day 5 and after 18 days
description: VAS scale (The visual analogue scale) It is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. This continuous (or "analogue") aspect of the scale differentiates it from discrete scales such as the Likert scale. There is evidence showing that visual analogue scales have superior metrical characteristics than discrete scales, thus a wider range of statistical methods can be applied to the measurements.
measure: Anxiety and Depression Index
time frame: on day 5 and after 18 days
description: HADS scale (Hospital Anxiety and Depression Scale) It was originally developed by Zigmond and Snaith (1983)and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Zigmond and Snaith created this outcome measure specifically to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. This, it was hoped, would create a tool for the detection of anxiety and depression in people with physical health problems.
arm group label: Study Group
arm group type: Active Comparator
description: The treatment included a comprehensive therapy: radon therapeutic baths and inhalations, kinesiotherapy. On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS scale.
arm group label: Control Group
arm group type: No Intervention
description: On the day of admission to the SPA the patients were subjected to subjective and objective examination. Laboratory tests (lipids profile, CRP, smear blood morphology, TAS- total antioxidative potential, metalloproteinase 8) were performed before treatment on day 5 and after 18 days. In addition, before and after treatment, standard scales were used to assess pain intensity: MCGill scale and VAS scale and anxiety and depression levels - HADS scale.
intervention type: Radiation
intervention name: Radon therapeutic baths and inhalations
description: The natural water with low mineralized content plays a major therapeutic role with the parameters of Rn 303,1-441,5 Bq/l. In the treatment rooms (inhalation, cabins with baths and swimming pool) measurement of alpha radiation was 184,4-450,0 MeV. The measurements were analyzed every 3 months at the Institute of Occupational Medicine in the Department of Radiation Protection in Lodz, Poland. Among the types of treatments used in the therapy there was: comprehensive radon bath - with the temperature of 37 °C, duration 15 min., the treatments were performed every 2nd day, whereas radon inhalations lasted 15 min. with the temp. 37 °C- treatments were performed every 2nd day from Monday to Friday. Baths and inhalations were performed interchangeably and the total number of radon treatments during one stay was 15.
arm group label: Study Group
intervention type: Procedure
intervention name: Kinesiotherapy
description: It is the therapeutic treatment of disease by passive and active muscular movements (as by massage) and of exercise. It is the core element of physiotherapy/physical therapy. Kinesiotherapy - duration of 30-45 min,
arm group label: Study Group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jadwiga Kuciel-Lewandowska, MD
role: Study Director
affiliation: MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw
responsible party type: Principal Investigator
investigator affiliation: Wroclaw Medical University
investigator full name: Jadwiga Kuciel-Lewandowska
investigator title: Doctor of Medicine
mesh term: Intervertebral Disc Degeneration
sharing ipd: Undecided
ipd description: Any request to share the IPD will be considered individually and in the group of all researchers who have participated in the research. Due to the law at the Medical University of Wroclaw every interested IPD of our study must also write a request to the Deputy Dean for the University of Medicine in Wroclaw to obtain access to such documents from him. The applicant will receive all contact details for the Deputy Dean for the University of Medical in Wroclaw when applying for access to the IPD.