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NCT Number: NCT03405350

Evaluation of Spa Medicine on the Example of Comprehensive Therapy in the Spa Resort Przerzeczyn Zdroj

Observation conducted during the 21 days of treatment in the health resort of Przerzeczyn Zdroj. In a treatment of applied therapy: redon-sulfide baths, partial mud baths, kinesitherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field, ultrasonotherapy, cryotherapy, electrotherapy, light therapy. Study group with joint or back pain due to osteoarthritis or degenerative disc disease. The control group was selected by the spa workers, healthy individuals, nonsmokers, who did not drink alcohol. It was recommended to retain the previous lifestyle and use of resort's facilities was prohibited. In both of these groups, appropriate pre- and post-treatment studies were performed.

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Key information

Conditions

Osteoarthritis Arthritis Bone Diseases Degenerative Disc Disease Intervertebral Disc Degeneration Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Spinal Diseases

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The observation was conducted during 21 days of medicinal stays in the health resort of Przerzeczyn Zdroj. The treatment included a comprehensive therapy: redon-sulfide baths, partial mud baths, kinesitherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field, ultrasonotherapy, cryotherapy, electrotherapy, light therapy.

The study group consisted of patients with joint or back pain due to osteoarthritis or degenerative 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, the concentration of endorphins and serotonin, bilirubin, uric acid, albumin) 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 VAS scale and anxiety and depression levels - HADS scale.

The control group was selected by the spa workers. 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, the concentration of endorphins and serotonin) 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: VAS scale and anxiety and depression levels - HADS scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the presence of degenerative disc disease and/or osteoarthritis ;
  • age range 30-69 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 30 and over 70 years;
  • the presence of diseases constituting a contraindication to therapy (compatible with the standard list of indications and contraindications to spa therapy);

Treatment and study plan

Redon-sulfide baths

Procedure

Encompassing whole body or isolated limbs - upper and/or lower limbs - temperature: 37-38 degrees Celsius, duration: 20 minutes.

Partial Mud Baths

Procedure

duration: 20 minutes, temperature 40-42 degrees Celsius

Kinesiotherapy

Procedure

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.

Terrain Therapy

Procedure

walking, outdoors physical activities,

Dry Massage

Procedure

Depending on the needs of each patient it involved cervical (CC), thoracic (TH), or lumbar spine (LS).

laser therapy

Procedure

treatment parameters: sweeping, continuous, wavelength 808 nm, power 12 J, 400mV, duration 30s,

Low-frequency Magnetic Field

Procedure

duration 20 minutes, impulse shape - rectangular, induction 5 mT, frequency 20-50Hz,

Ultrasonotherapy

Procedure

treatment parameters: 800kHz/6cm2 head, ultrasound impulse wave: 2ms - impulse, 9ms - break, dose 0.5-0.6 W/cm2 over 6 minutes,

cryotherapy

Procedure

ventilator, treatment duration 2-3 minutes, temperature - 80 to - 110 degrees Celsius,

Electrotherapy

Procedure

Bernard's diadynamic currents - treatment parameters: DF1 CP4 LP4, Nemec interference currents (frequency range 0-100Hz), percutaneous electrostimulation (TENS) - rectangular impulse currents, impulse duration 0.2ms, frequency 40Hz, regulated current 0-100mA,

Light Therapy

Procedure

blue filter Sollux lamp, radiation distance 30-40 cm, duration 15 minutes, Bioptron lamp - radiation distance 10 cm, duration 5-10 minutes

Primary outcomes

  1. Change of results Laboratory tests (lipids profile, CRP, smear blood morphology) 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.

  2. Change of results TAS- total antioxidative potential

    Time frame: on day 5 and after 18 days of therapy

    The biological material was taken with sterile disposable equipment. After 5 ml of venous blood was collected in the closed system directly into the monoveta was centrifuged to obtain serum - a sample to be tested for TAS. Subsequently, 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.

  3. Change of results the concentration of endorphins and serotonin

    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 the closed system will be left to solidify - sample for the concentration of endorphins and serotonin. Subsequently, 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 23, 2018
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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