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

NCT ID: NCT06895434

Last Updated: 2025-03-26

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2020-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Balneology Blood Pressure Heart Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Balneotherapy with physical therapy

Intervention Type 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.

Only physical therapy

Patients in group 2 were applied only a physical therapy program.

Group Type ACTIVE_COMPARATOR

Physical therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Transcutaneous Electrical Nerve Stimulation (TENS) Hot Pack Ultrasound(US) Therapy Transcutaneous Electrical Nerve Stimulation (TENS) Hot Pack Ultrasound(US) Therapy

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role collaborator

Uşak University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kağan Özkuk

Role: STUDY_DIRECTOR

Uşak University

Locations

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UsakU

Merkez, Uşak, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Balneotherapy +Blood Pressure

Identifier Type: -

Identifier Source: org_study_id

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