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CompletedNCT03405350Updated Jan 23, 2018

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

An interventional study of Redon-sulfide baths and Partial Mud Baths in Osteoarthritis and Degenerative Disc Disease, sponsored by Wroclaw Medical University. Completed. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Non-randomized
Ages
30 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis
  • Degenerative Disc Disease
03

Who can participate

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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);
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Active comparator
    Study Group

    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.

    Procedure: Redon-sulfide baths · Procedure: Partial Mud Baths · Procedure: Kinesiotherapy · Procedure: Terrain Therapy · Procedure: Dry Massage · Procedure: Laser Therapy · Procedure: Low-frequency Magnetic Field · Procedure: Ultrasonotherapy · Procedure: Cryotherapy · Procedure: Electrotherapy · Procedure: Light Therapy

  • 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, 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.

Interventions

  • ProcedureRedon-sulfide baths

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

  • ProcedurePartial Mud Baths

    duration: 20 minutes, temperature 40-42 degrees Celsius

  • ProcedureKinesiotherapy

    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.

  • ProcedureTerrain Therapy

    walking, outdoors physical activities,

  • ProcedureDry Massage

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

  • ProcedureLaser Therapy

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

  • ProcedureLow-frequency Magnetic Field

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

  • ProcedureUltrasonotherapy

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

  • ProcedureCryotherapy

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

  • ProcedureElectrotherapy

    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,

  • ProcedureLight Therapy

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

05

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. 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.

    Time frame: on day 5 and after 18 days

  2. 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.

    Time frame: on day 5 and after 18 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 32774419 ↗
  • 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. PubMed 32377287 ↗
  • 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. PubMed 32089783 ↗

Individual participant data

Plan to share: Undecided — Any request to share the IPD will be considered individually and in the group of all researchers who have participated in the research.

08

Registry details

Key details

Study ID
NCT03405350
Lead sponsor
Wroclaw Medical University
Responsible party
Jadwiga Kuciel-Lewandowska (Doctor of Medicine, Wroclaw Medical University) — Principal investigator
First posted
Jan 23, 2018
Start date
Jan 2009
Primary completion
Jan 2010
Completion
Dec 2011
Last update
Jan 23, 2018

Study contacts

Jadwiga Kuciel-Lewandowska, MD
study director · MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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