Low Back PainNCT07005375
The Effect of Bathing in the Thermal Mineral Water on the Pain and Performance of Athletes
A study testing thermal mineral water bath in people with Low Back Pain and Fatigue Recovery, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 1 site in Hungary.
Trial summary
Effect of bathing in the thermal mineral water well on the performance and potential pain of athletes. Randomized, controlled, single-blind study. Read more about this study
- Who is it for?
- Ages 14 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Fatigue Recovery, Performance Measures
- What is being tested?
- thermal mineral water bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Rowers coming from the surrounding area, with registration at the Hungarian Rowing Federation (MESZ), including competitive/touring and recreational/masters rowers
- Women and men between 18 and 75 years of age
- Participating in regular training for at least 6 months
- Signed informed consent form prior to the start of the study
Who cannot join
- Acute pain;
- Organic neurological deficit;
- Malignancy in the background;
- Pain attributable to inflammatory disease;
- Participants must not have received systemic or local steroid therapy, physiotherapy as a course of treatment, massage therapy, or balneotherapy as a course of treatment within 3 months prior to the study;
- General contraindications of balneotherapy:
Show all 15Show fewer
- unstable angina pectoris,
- uncontrolled hypertension,
- cardiac decompensation,
- respiratory failure,
- unbalanced endocrinological disease,
- acute febrile condition,
- infectious skin diseases,
- other serious internal, urogenital, and other diseases, urinary and fecal incontinence,
- decompensated psychosis and neurosis, lack of compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Hospital Budai Irgalmasrendi Kórház Nonprofit Kft.
Budapest, Budapest, 1027
About this study
Effect of bathing in the thermal mineral water well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.
Read the detailed description
In rowing sports, where the same series of movements are repeated thousands of times, the lower lumbar region is the most stressed part. Because of this, even training on an ergometer can cause numerous lower back problems, even among competitors. In addition, rowers use many muscle groups during their sport, for which the beneficial effect of thermal medicinal waters, affecting the entire musculoskeletal system, can be beneficial, and is used for rehabilitation purposes in several countries.
Studies describe the numerous positive effects of bathing in warm water (37-46°C) in increasing blood flow, regulating blood sugar, and even the positive response of the vascular system.
The Palatinus Spa's water supply is provided by the drilled thermal wells of Margit Island of Budapest.
Regarding its type, the medicinal water is a low salt concentration, calcium-magnesium-hydrogen carbonate, chloride, and sulfate medicinal water, which also has a significant fluoride and metasilicic acid content. The total dissolved mineral content is 1205 mg/liter. In the study, we would conduct the clinical trial necessary for the "Margaret Island mineral water" / 37-38 °C / thermal mineral water of the Margitszigeti É. III well to be declared medicinal water.
Research Question Primary objective: Effect of bathing in the "Margaret Island mineral water" thermal mineral water of the Margaret Island III well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.
Secondary objective: To what extent does thermal water treatment lead to a change in the quality of life of those receiving it compared to their initial condition, and what is the magnitude of this change compared to the control group?
- Conditions
- Low Back Pain, Fatigue Recovery, Performance Measures
- Being tested
- thermal mineral water bath
- Keywords
- low back pain, fatigue, performance
- Medical subject headings
- Low Back Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal mineral water bathBehavioural
Also called water, thermal water, mineral water
One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan.
| Study group | Role | What they receive |
|---|---|---|
| Athletes/rowing | Active comparator | Patients were enrolled if they met the inclusion and exclusion criteria. The classification would be based on a randomization list. Measurements, clinical examinations, and evaluation of pain and functional status-related quality of life will be performed before, immediately after the treatments, and 3 months later. One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan. The thermal mineral water-treated group and the control group may not receive systemic or locally administered steroid therapy during the study, and the control group may not receive balneotherapy. Receives: Behavioral: thermal mineral water bath |
| Athletes | Active comparator | One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan.
Rowers coming from the surrounding area, with registration at the Hungarian Rowing Federation Receives: Behavioral: thermal mineral water bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group. This would be measured by the improvement in 6000-meter ergometer performance.
The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group. This would be measured by the improvement in 6000-meter ergometer performance. Examining the change in threshold load with improving parameters and heart rate variability (HRV) (examining how the heart is able to continuously change the duration between heartbeats (RR intervals) in response to changes in internal and external environmental loads, and thereby showing the heart's adaptation. This adaptability of the heart is based on the optimal interplay and cooperation of the sympathetic and parasympathetic nervous systems.)
Measured: 3 months
Secondary outcomes (1)
The extent of the change in fatigue, muscle pain, and discomfort between workouts measured by VAS in the balneotherapy group compared to the change in the control group.
The extent of the change in fatigue, muscle pain, and discomfort between workouts measured by 1-10 points on a VAS in the balneotherapy group compared to the change in the control group. Change in lumbar spine movement function in cm. Specific questionnaire for lower back pain (Oswestry) Quality of life questionnaire (EuroQuol-5D-5L) Change in medication therapy used for pain. The extent of change on the Borg scale 0-10 points (How much did you exert yourself?)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jul 2024
- Primary completion11 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, single-blind study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Gati, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005375
- Sponsor's protocol ID
- Medicinal Water and Rowing
- Other IDs
- NNGYK/GYSZ/3848-8/2024
- Status last verified
- Jun 2025
- First submitted
- 21 Apr 2025
- Last updated
- 8 Jun 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bathing in the Thermal Mineral Water on the Pain and Performance of Athletes
- ClinicalTrials.gov ID
- NCT07005375
- Acronym / sponsor ID
- Medicinal Water and Rowing
- Conditions
- Low Back Pain, Fatigue Recovery, Performance Measures
- Keywords
- low back pain, fatigue, performance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, BudapestUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 11 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 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.
Effect of bathing in the thermal mineral water well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.
Detailed description
In rowing sports, where the same series of movements are repeated thousands of times, the lower lumbar region is the most stressed part. Because of this, even training on an ergometer can cause numerous lower back problems, even among competitors. In addition, rowers use many muscle groups during their sport, for which the beneficial effect of thermal medicinal waters, affecting the entire musculoskeletal system, can be beneficial, and is used for rehabilitation purposes in several countries.
Studies describe the numerous positive effects of bathing in warm water (37-46°C) in increasing blood flow, regulating blood sugar, and even the positive response of the vascular system.
The Palatinus Spa's water supply is provided by the drilled thermal wells of Margit Island of Budapest.
Regarding its type, the medicinal water is a low salt concentration, calcium-magnesium-hydrogen carbonate, chloride, and sulfate medicinal water, which also has a significant fluoride and metasilicic acid content. The total dissolved mineral content is 1205 mg/liter. In the study, we would conduct the clinical trial necessary for the "Margaret Island mineral water" / 37-38 °C / thermal mineral water of the Margitszigeti É. III well to be declared medicinal water.
Research Question Primary objective: Effect of bathing in the "Margaret Island mineral water" thermal mineral water of the Margaret Island III well on the performance and potential pain of athletes. Randomized, controlled, single-blind study.
Secondary objective: To what extent does thermal water treatment lead to a change in the quality of life of those receiving it compared to their initial condition, and what is the magnitude of this change compared to the control group?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-blind study.
| Arm | Type | Receives |
|---|---|---|
| Athletes/rowing | Active comparator | Behavioral: thermal mineral water bathPatients were enrolled if they met the inclusion and exclusion criteria. The classification would be based on a randomization list. Measurements, clinical examinations, and evaluation of pain and functional status-related quality of life will be performed before, immediately after the treatments, and 3 months later. One group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan. The thermal mineral water-treated group and the control group may not receive systemic or locally administered steroid therapy during the study, and the control group may not receive balneotherapy. |
| Athletes | Active comparator | Behavioral: thermal mineral water bathOne group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan. Rowers coming from the surrounding area, with registration at the Hungarian Rowing Federation |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Rowers coming from the surrounding area, with registration at the Hungarian Rowing Federation (MESZ), including competitive/touring and recreational/masters rowers
- Women and men between 18 and 75 years of age
- Participating in regular training for at least 6 months
- Signed informed consent form prior to the start of the study
Key exclusion criteria (15 listed)
- Acute pain;
- Organic neurological deficit;
- Malignancy in the background;
- Pain attributable to inflammatory disease;
- Participants must not have received systemic or local steroid therapy, physiotherapy as a course of treatment, massage therapy, or balneotherapy as a course of treatment within 3 months prior to the study;
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 |
|---|---|---|
| thermal mineral water bathAlso: water, thermal water, mineral waterOne group will bathe in a pool filled with 36°C thermal mineral water of the Palatinus Spa for 3 weeks, 5 days a week, for a total of 15 sessions, 20 minutes per session. Bathing in the thermal mineral water takes place in the medicinal water pool. The control group does not receive balneotherapy. Both groups can continue their usual training plan. | Behavioural | Athletes, Athletes/rowing |
Primary outcome
The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group. This would be measured by the improvement in 6000-meter ergometer performance.
Time frame: 3 months
The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group. This would be measured by the improvement in 6000-meter ergometer performance. Examining the change in threshold load with improving parameters and heart rate variability (HRV) (examining how the heart is able to continuously change the duration between heartbeats (RR intervals) in response to changes in internal and external environmental loads, and thereby showing the heart's adaptation. This adaptability of the heart is based on the optimal interplay and cooperation of the sympathetic and parasympathetic nervous systems.)
1 secondary outcome
The extent of the change in fatigue, muscle pain, and discomfort between workouts measured by VAS in the balneotherapy group compared to the change in the control group.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermal mineral water bath in people with Low Back Pain and Fatigue Recovery, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 1 site in Hungary.
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 4 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
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?
The extent of the effect and change on the performance of athletes and any existing pain in the balneotherapy group compared to the change in the control group. This would be measured by the improvement in 6000-meter ergometer performance. (time frame: 3 months). 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 8 Jun 2025.