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

NCT03405350 | Completed DMC

• 1 other identifier: KB 401/2008
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  on day 5 and after 18 days of therapy

• 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.

  on day 5 and after 18 days of therapy

• 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.

  on day 5 and after 18 days of therapy

Secondary Outcomes (2)

• Pain Index

  on day 5 and after 18 days

• Anxiety and Depression Index

  on day 5 and after 18 days

Study Arms (2)

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.

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

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.

Interventions

Redon-sulfide baths PROCEDURE

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

Study Group

Partial Mud Baths PROCEDURE

duration: 20 minutes, temperature 40-42 degrees Celsius

Study Group

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.

Study Group

Terrain Therapy PROCEDURE

walking, outdoors physical activities,

Study Group

Dry Massage PROCEDURE

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

Study Group

Laser Therapy PROCEDURE

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

Study Group

Low-frequency Magnetic Field PROCEDURE

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

Study Group

Ultrasonotherapy PROCEDURE

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

Study Group

Cryotherapy PROCEDURE

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

Study Group

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,

Study Group

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

Study Group

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Wroclaw Medical University: lead

Related Publications (3)

• 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.

  PMID: 32774419 DERIVED

• 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.

  PMID: 32377287 DERIVED

• 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.

  PMID: 32089783 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Intervertebral Disc Degeneration

Interventions

Laser Therapy; Cryotherapy; Electric Stimulation Therapy; Phototherapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Spinal Diseases; Bone Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jadwiga Kuciel-Lewandowska, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 23, 2018
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2011
• Last Updated: January 23, 2018

Record last verified: 2018-01