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OsteoarthritisNCT03274128

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

A study testing Radon therapeutic baths and inhalations and Kinesiotherapy in people with Osteoarthritis and Degenerative Disc Disease, run by Wroclaw Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Osteoarthritis, Degenerative Disc Disease
What is being tested?
Radon therapeutic baths and inhalations and Kinesiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
No sites listed yet
Study dates
1 Mar 2015to 30 Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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.

Read the 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.

Being tested
Radon therapeutic baths and inhalations, Kinesiotherapy
Medical subject headings
Osteoarthritis, Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radon therapeutic baths and inhalationsRadiation

    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.

  • KinesiotherapyProcedure or surgery

    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,

Study groups in NCT03274128
Study groupRoleWhat they receive
Study GroupActive comparatorThe 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.
Receives: Radiation: Radon therapeutic baths and inhalations; Procedure: Kinesiotherapy
Control GroupNo interventionOn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: on day 5 and after 18 days of therapy

Secondary outcomes (3)

  1. Pain Index

    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.

    Measured: on day 5 and after 18 days

  2. Pain Index

    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.

    Measured: on day 5 and after 18 days

  3. Anxiety and Depression Index

    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.

    Measured: on day 5 and after 18 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2017
  2. Study start1 Mar 2015
  3. Primary completion30 Apr 2015
  4. Study completion30 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03274128
Sponsor's protocol ID
KLASTER - 3/2014
Status last verified
Apr 2020
First submitted
31 Aug 2017
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Kuciel-Lewandowska J, Kasperczak M, Pawlik-Sobecka L, Paprocka-Borowicz M, Gnus J. Assessment of Changes in Concentration of Total Antioxidant Status, Acute-Phase Protein, and Prolactin in Patients with Osteoarthritis Subjected to a Complex Spa Treatment with Radon Water: Preliminary Results. PPAR Res. 2020 Apr 23;2020:9459418. doi: 10.1155/2020/9459418. eCollection 2020.

    PubMed 32373171

  • Kasperczak M, Kuciel-Lewandowska J, Gnus J, Paprocka-Borowicz M. Assessment of Changes in Lipids Metabolism in Patients with Degenerative Joints and Discs Diseases Subjected to Spa Therapy. Biomed Res Int. 2019 Jul 24;2019:4732654. doi: 10.1155/2019/4732654. eCollection 2019.

    PubMed 31428637

  • Kuciel-Lewandowska J, Gnus J, Pawlik-Sobecka L, Placzkowska S, Kokot I, Kasperczak M, Paprocka-Borowicz M. The Assessment of the Integrated Antioxidant System of the Body in the Course of Radon Therapy: A Pilot Study. Biomed Res Int. 2018 Jan 2;2018:6038106. doi: 10.1155/2018/6038106. eCollection 2018.

    PubMed 29487870

Questions about this trial

What is this clinical trial studying?

A study testing Radon therapeutic baths and inhalations and Kinesiotherapy in people with Osteoarthritis and Degenerative Disc Disease, run by Wroclaw Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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 (time frame: on day 5 and after 18 days of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03274128, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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