BalneologyNCT06895434
Effect of Repeated Thermomineral Water Immersion on Blood Pressure and Heart Rate in Individuals with Chronic Pain Due to Musculoskeletal System Diseases
A study testing Balneotherapy with physical therapy and Physical therapy in people with Balneology and Blood Pressure, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Balneology, Blood Pressure, Heart Rate
- What is being tested?
- Balneotherapy with physical therapy and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2020to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 45 and 75
- Patients with pain associated with rheumatic diseases
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Balneology, Blood Pressure, Heart Rate
- Being tested
- Balneotherapy with physical therapy, Physical therapy
- Keywords
- Balneotherapy, Blood Pressure, Cardiac Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balneotherapy with physical therapyOther
Also called Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) 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.
Physical therapyOther
Also called Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) 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.
| Study group | Role | What they receive |
|---|---|---|
| Balneotherapy with physical therapy | Active comparator | 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. Receives: Other: Balneotherapy with physical therapy |
| Only physical therapy | Active comparator | Patients in group 2 were applied only a physical therapy program. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start7 Feb 2020
- Primary completion27 May 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalneologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University
- Responsible party
- Sponsor
- Investigators
- Kağan Özkuk, Study director, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895434
- Sponsor's protocol ID
- Balneotherapy +Blood Pressure
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Balneotherapy Affect Blood Pressure and Pulse?
- ClinicalTrials.gov ID
- NCT06895434
- Acronym / sponsor ID
- Balneotherapy +Blood Pressure
- Conditions
- Balneology, Blood Pressure, Heart Rate
- Keywords
- Balneotherapy, Blood Pressure, Cardiac Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneotherapy with physical therapy | Active comparator | Other: Balneotherapy with physical therapyBalneotherapy 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. |
| Only physical therapy | Active comparator | Other: Physical therapyPatients in group 2 were applied only a physical therapy program. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 45 and 75
- Patients with pain associated with rheumatic diseases
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balneotherapy with physical therapyAlso: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) TherapyBalneotherapy 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 | Balneotherapy with physical therapy |
| Physical therapyAlso: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) TherapyA 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 | Only physical therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Balneology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kağan Özkuk study director
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balneotherapy with physical therapy and Physical therapy in people with Balneology and Blood Pressure, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.