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Evaluation of the Effectiveness of Spa Treatment in Swieradow Zdroj With Special Regard to the Action of Radon Waters

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ClinicalTrials.gov Identifier: NCT03274128
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jadwiga Kuciel-Lewandowska, Wroclaw Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Degenerative Disc Disease Radiation: Radon therapeutic baths and inhalations Procedure: Kinesiotherapy Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : March 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Radon

Arm Intervention/treatment
Active Comparator: Study Group
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.
Radiation: Radon therapeutic baths and inhalations
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.

Procedure: Kinesiotherapy
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,

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Pain Index [ Time Frame: on day 5 and after 18 days ]
    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.

  2. Pain Index [ Time Frame: on day 5 and after 18 days ]
    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.

  3. Anxiety and Depression Index [ Time Frame: on day 5 and after 18 days ]
    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.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the presence of degenerative joints and/or disc disease;
  • age range 40-60 years;
  • the written consent to participate in research;
  • no impediment to comprehensive treatment at the spa.

Exclusion Criteria:

  • the lack of consent to participate in research;
  • the age under 40 and over 60 years;
  • the presence of diseases constituting a contraindication to therapy (compatible with the standard list of indications and contraindications to spa therapy);
  • the presence of metabolic diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274128


Sponsors and Collaborators
Wroclaw Medical University
Investigators
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Study Director: Jadwiga Kuciel-Lewandowska, MD MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jadwiga Kuciel-Lewandowska, Doctor of Medicine, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03274128     History of Changes
Other Study ID Numbers: KLASTER - 3/2014
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases