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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Degenerative Disc Disease
• Intervention / Treatment: Radiation: Radon therapeutic baths and inhalations; Procedure: Kinesiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	on day 5 and after 18 days of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	on day 5 and after 18 days
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.	on day 5 and after 18 days
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.	on day 5 and after 18 days

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): April 30, 2015
• Study Completion (Actual): March 30, 2016

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 3, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: KLASTER - 3/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No