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Completed

NCT Number: NCT06895434

Effect of Repeated Thermomineral Water Immersion on Blood Pressure and Heart Rate in Individuals with Chronic Pain Due to Musculoskeletal System Diseases

Purpose: This study aimed to investigate the effect of balneotherapy on blood pressure and heart rate in patients.

Methods: A total of 240 participants who met the inclusion criteria of the study were divided into 2 groups (120 participants in each group).

A 10-session physical therapy was applied to all participants in both groups. Balneotherapy was applied to Group I.

The participants filled out a questionnaire containing demographic data, and participants arterial blood pressures and heart rate were measured and recorded before and after treatment throughout the treatment.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UsakU

Merkez, Uşak, 64200, Turkey (Türkiye)

About this study

INTRODUCTION: Spa treatment is an additional and auxiliary method that has an important place in the prevention, treatment and rehabilitation of a wide variety of diseases. The majority of people who go to thermal springs for treatment have rheumatic diseases, followed by dermatological, gastrointestinal and gynecological diseases. However, outside these disease groups, the place of spa treatment and its most basic element, thermomineral water and mud, that is, balneotherapy, is increasing.

Answers to questions such as in what direction and how these factors affect a human organism in water (during immersion) form the basis of balneotherapy in cardiovascular diseases. For this purpose, the investigators planned to investigate the effects of balneotherapy on blood pressure and heart rate in patients.

METHODS The study was designed as a prospective, randomized, controlled, and single-blind study. A total of 240 participants who applied to the medical ecology and hydroclimatology and physical therapy and rehabilitation outpatient clinic with pain complaints, met the study criteria and signed the participants information consent form were included in the study.

A total of 240 participants who met the inclusion criteria of the study were divided into 2 groups (120 participants in each group) with simple randomization method by using a table of random numbers created on the computer. The researchers who made the assessment measurements were unaware of which participant was in which group. Statistical analysis of the results was performed by a biostatistician who had no information about the therapies the participant groups received.

All participants in both groups underwent a 10-session physical therapy program (e.g. Hot pack, TENS, ultrasound, etc.) to the areas of pain. Balneotherapy was applied to group I before treatment. Balneotherapy applied in the thermal pools to patients for 20 minutes, at a temperature of 38-40°C. After resting for 30 minutes,physical therapy was applied.

The participants filled out a questionnaire containing demographic data, and arterial blood pressures and heart rate were measured and recorded before and after treatment throughout the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 45 and 75
  • Patients with pain associated with rheumatic diseases

Exclusion criteria

  • Inflammatory rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, etc.),
  • Diagnosed with uncontrolled arterial hypertension and diabetes mellitus,
  • Having a diagnosed neuro-psychiatric problem,
  • Undergoing malignancy treatment,
  • Having a bleeding disease,
  • Having an infectious disease with fever,
  • Patients who received physical therapy, balneotherapy or both in the last six mounths.

Treatment and study plan

Balneotherapy with physical therapy

Other

Balneotherapy applied in the thermal pools to patients for 20 minutes, at a temperature of 38-40°C. After resting for 30 minutes,physical therapy was applied.

A physical therapy program (5 days a week for 2 weeks, a total of 10 sessions) was applied to the painful area, including 20 minutes of hot pack at 60°C, 20 minutes of conventional TENS at 80 Hz and US at 3 MHz frequency and 1.5 watt/cm2 intensity.

Other names: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy

Physical Therapy

Other

A physical therapy program (5 days a week for 2 weeks, a total of 10 sessions) was applied to the painful area, including 20 minutes of hot pack at 60°C, 20 minutes of conventional TENS at 80 Hz and US at 3 MHz frequency and 1.5 watt/cm2 intensity.

Other names: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy

Primary outcomes

  1. Blood pressure and heart rate

    Time frame: Measurements were made on the individuals included in the study from the beginning to the end of the treatment protocol (on the days of treatment - 10 days in total).

    Only blood pressure and heart rate measurements were made of the participants, no other measurements or evaluations were made. Blood pressure and heart rate were measured in all patients before starting their treatment and at the end of the treatment, after 30 minutes of rest.

    Blood pressure and heart rate was evaluated with a non invasive sphygmomanometer on the same arm (right) (OMRON HBP-1320).

    The pulse number was confirmed by measuring with the researcher's three fingers on the radial artery.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Collaborators

  • Abant Izzet Baysal University

Registry information

Official study title

Does Balneotherapy Affect Blood Pressure and Pulse?

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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