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Clinical Trials/NCT03405350
NCT03405350CompletedNot Applicable

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

Wroclaw Medical University0 sites127 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
127
Primary Endpoint
Change of results TAS- total antioxidative potential

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 69 Years (Adult, Older Adult)
Sex
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

  • 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);

Arms & Interventions

Study Group

Active Comparator

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.

Intervention: Redon-sulfide baths (Procedure)

Study Group

Active Comparator

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.

Intervention: Partial Mud Baths (Procedure)

Study Group

Active Comparator

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.

Intervention: Kinesiotherapy (Procedure)

Study Group

Active Comparator

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.

Intervention: Terrain Therapy (Procedure)

Study Group

Active Comparator

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.

Intervention: Dry Massage (Procedure)

Study Group

Active Comparator

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.

Intervention: Laser Therapy (Procedure)

Study Group

Active Comparator

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.

Intervention: Low-frequency Magnetic Field (Procedure)

Study Group

Active Comparator

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.

Intervention: Ultrasonotherapy (Procedure)

Study Group

Active Comparator

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.

Intervention: Cryotherapy (Procedure)

Study Group

Active Comparator

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.

Intervention: Electrotherapy (Procedure)

Study Group

Active Comparator

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.

Intervention: Light Therapy (Procedure)

Control Group

No Intervention

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 Outcomes

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.

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.

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.

Secondary Outcomes

  • Pain Index(on day 5 and after 18 days)
  • Anxiety and Depression Index(on day 5 and after 18 days)

Investigators

Sponsor
Wroclaw Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jadwiga Kuciel-Lewandowska

Doctor of Medicine

Wroclaw Medical University

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