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

Primary Purpose

Osteoarthritis, Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Redon-sulfide baths
Partial Mud Baths
Kinesiotherapy
Terrain Therapy
Dry Massage
Laser Therapy
Low-frequency Magnetic Field
Ultrasonotherapy
Cryotherapy
Electrotherapy
Light Therapy
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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);

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Study Group

    Control Group

    Arm Description

    The treatment included a comprehensive therapy: redon-sulfide baths, partial mud baths, kinesiotherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field, ultrasonotherapy, cryotherapy, electrotherapy, light 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.

    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.

    Outcomes

    Primary Outcome Measures

    Change of results Laboratory tests (lipids profile, CRP, smear blood morphology) 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.
    Change of results TAS- total antioxidative potential
    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.
    Change of results the concentration of endorphins and serotonin
    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 Outcome Measures

    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.
    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.

    Full Information

    First Posted
    January 4, 2018
    Last Updated
    January 18, 2018
    Sponsor
    Wroclaw Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03405350
    Brief Title
    Evaluation of Spa Medicine on the Example of Comprehensive Therapy in the Spa Resort Przerzeczyn Zdroj
    Official Title
    Evaluation of Spa Medicine on the Example of Comprehensive Therapy in the Spa Resort Przerzeczyn Zdroj
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (Actual)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wroclaw Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Degenerative Disc Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    127 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Active Comparator
    Arm Description
    The treatment included a comprehensive therapy: redon-sulfide baths, partial mud baths, kinesiotherapy, terrain therapy, dry massage, laser therapy, low-frequency magnetic field, ultrasonotherapy, cryotherapy, electrotherapy, light 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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Redon-sulfide baths
    Intervention Description
    Encompassing whole body or isolated limbs - upper and/or lower limbs - temperature: 37-38 degrees Celsius, duration: 20 minutes.
    Intervention Type
    Procedure
    Intervention Name(s)
    Partial Mud Baths
    Intervention Description
    duration: 20 minutes, temperature 40-42 degrees Celsius
    Intervention Type
    Procedure
    Intervention Name(s)
    Kinesiotherapy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Terrain Therapy
    Intervention Description
    walking, outdoors physical activities,
    Intervention Type
    Procedure
    Intervention Name(s)
    Dry Massage
    Intervention Description
    Depending on the needs of each patient it involved cervical (CC), thoracic (TH), or lumbar spine (LS).
    Intervention Type
    Procedure
    Intervention Name(s)
    Laser Therapy
    Intervention Description
    treatment parameters: sweeping, continuous, wavelength 808 nm, power 12 J, 400mV, duration 30s,
    Intervention Type
    Procedure
    Intervention Name(s)
    Low-frequency Magnetic Field
    Intervention Description
    duration 20 minutes, impulse shape - rectangular, induction 5 mT, frequency 20-50Hz,
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasonotherapy
    Intervention Description
    treatment parameters: 800kHz/6cm2 head, ultrasound impulse wave: 2ms - impulse, 9ms - break, dose 0.5-0.6 W/cm2 over 6 minutes,
    Intervention Type
    Procedure
    Intervention Name(s)
    Cryotherapy
    Intervention Description
    ventilator, treatment duration 2-3 minutes, temperature - 80 to - 110 degrees Celsius,
    Intervention Type
    Procedure
    Intervention Name(s)
    Electrotherapy
    Intervention Description
    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,
    Intervention Type
    Procedure
    Intervention Name(s)
    Light Therapy
    Intervention Description
    blue filter Sollux lamp, radiation distance 30-40 cm, duration 15 minutes, Bioptron lamp - radiation distance 10 cm, duration 5-10 minutes
    Primary Outcome Measure Information:
    Title
    Change of results Laboratory tests (lipids profile, CRP, smear blood morphology) on day 5 and after 18 days of therapy
    Description
    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.
    Time Frame
    on day 5 and after 18 days of therapy
    Title
    Change of results TAS- total antioxidative potential
    Description
    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.
    Time Frame
    on day 5 and after 18 days of therapy
    Title
    Change of results the concentration of endorphins and serotonin
    Description
    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.
    Time Frame
    on day 5 and after 18 days of therapy
    Secondary Outcome Measure Information:
    Title
    Pain Index
    Description
    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.
    Time Frame
    on day 5 and after 18 days
    Title
    Anxiety and Depression Index
    Description
    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.
    Time Frame
    on day 5 and after 18 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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);
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jadwiga Kuciel-Lewandowska, MD
    Organizational Affiliation
    MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    32774419
    Citation
    Kuciel-Lewandowska J, Kasperczak M, Paprocka-Borowicz M. Assessment of Changes in the Hemoglobin Level under the Influence of Comprehensive Spa Therapy Using Therapeutic Radon-Sulfur Waters and Its Correlation with Free Radical Reactions. Evid Based Complement Alternat Med. 2020 Jul 20;2020:4637129. doi: 10.1155/2020/4637129. eCollection 2020.
    Results Reference
    derived
    PubMed Identifier
    32377287
    Citation
    Kuciel-Lewandowska J, Kasperczak M, Lewandowski LB, Paprocka-Borowicz M. Assessment of the Level of Pain Intensity and the Level of Anxiety Treated as State and Trait in Patients with Osteoarthritis of the Limbs. Pain Res Manag. 2020 Apr 23;2020:5904743. doi: 10.1155/2020/5904743. eCollection 2020.
    Results Reference
    derived
    PubMed Identifier
    32089783
    Citation
    Kuciel-Lewandowska J, Kasperczak M, Bogut B, Heider R, Laber WT, Laber W, Paprocka-Borowicz M. The Impact of Health Resort Treatment on the Nonenzymatic Endogenous Antioxidant System. Oxid Med Cell Longev. 2020 Jan 31;2020:8423105. doi: 10.1155/2020/8423105. eCollection 2020.
    Results Reference
    derived

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

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