Clinical trial NCT06895434: Effect of Repeated Thermomineral Water Immersion on Blood Pressure and Heart Rate in Individuals with Chronic Pain Due to Musculoskeletal System Diseases
Official title: Does Balneotherapy Affect Blood Pressure and Pulse?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balneology
Blood Pressure
Heart Rate
Keywords: Balneotherapy
Blood Pressure
Cardiac Rate
Lead sponsor: Uşak University
Sponsor class: OTHER
Collaborators: name: Abant Izzet Baysal University
First posted: 2025-03-26
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood pressure and heart rate
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: UsakU
state: Uşak
Study officials:
affiliation: Uşak University
name: Kağan Özkuk
role: STUDY_DIRECTOR
References: