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

NCT ID: NCT03405350

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Degenerative Disc Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Redon-sulfide baths

Intervention Type PROCEDURE

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

Partial Mud Baths

Intervention Type PROCEDURE

duration: 20 minutes, temperature 40-42 degrees Celsius

Kinesiotherapy

Intervention Type 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

Intervention Type PROCEDURE

walking, outdoors physical activities,

Dry Massage

Intervention Type PROCEDURE

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

Laser Therapy

Intervention Type PROCEDURE

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

Low-frequency Magnetic Field

Intervention Type PROCEDURE

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

Ultrasonotherapy

Intervention Type PROCEDURE

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

Cryotherapy

Intervention Type PROCEDURE

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

Electrotherapy

Intervention Type 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

Intervention Type PROCEDURE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Redon-sulfide baths

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

Intervention Type PROCEDURE

Partial Mud Baths

duration: 20 minutes, temperature 40-42 degrees Celsius

Intervention Type PROCEDURE

Kinesiotherapy

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

Terrain Therapy

walking, outdoors physical activities,

Intervention Type PROCEDURE

Dry Massage

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

Intervention Type PROCEDURE

Laser Therapy

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

Intervention Type PROCEDURE

Low-frequency Magnetic Field

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

Intervention Type PROCEDURE

Ultrasonotherapy

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

Cryotherapy

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

Intervention Type PROCEDURE

Electrotherapy

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

Light Therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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);
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jadwiga Kuciel-Lewandowska

Doctor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jadwiga Kuciel-Lewandowska, MD

Role: STUDY_DIRECTOR

MD, Departament of Spa Treatment, History Physical Medicine and Balneology Medical University of Wroclaw

References

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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.

Reference Type DERIVED
PMID: 32774419 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32377287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32089783 (View on PubMed)

Other Identifiers

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KB 401/2008

Identifier Type: -

Identifier Source: org_study_id

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