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

Does Balneotherapy Affect Blood Pressure and Pulse?

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Heart Rate; Balneology
• Intervention / Treatment: Other: Balneotherapy with physical therapy; Other: Physical therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Uşak
    • Merkez, Uşak, Turkey, 64200
      • UsakU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Balneotherapy with physical therapy; 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.	Other: Balneotherapy with physical therapy; 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
Active Comparator: Only physical therapy; Patients in group 2 were applied only a physical therapy program.	Other: Physical therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure and heart rate	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.	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).

Collaborators and Investigators

• Sponsor: Uşak University
• Collaborators: Abant Izzet Baysal University
• Investigators: Study Director: Kağan Özkuk, Uşak University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): May 27, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Estimated): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Blood Pressure; Balneotherapy; Cardiac Rate
• Other Study ID Numbers: Balneotherapy +Blood Pressure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No