Clinical trial NCT03274128: Evaluation of the Effectiveness of Spa Treatment in Swieradow Zdroj With Special Regard to the Action of Radon Waters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Degenerative Disc Disease
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
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
timeFrame: on day 5 and after 18 days of therapy
Secondary outcomes:
measure: Pain Index
timeFrame: on day 5 and after 18 days
measure: Pain Index
timeFrame: on day 5 and after 18 days
measure: Anxiety and Depression Index
timeFrame: on day 5 and after 18 days
Other outcomes:
Locations:
Study officials:
affiliation: MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw
name: Jadwiga Kuciel-Lewandowska, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.