Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-07 @ 1:23 PM
Study NCT ID:
NCT06895434
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Repeated Thermomineral Water Immersion on Blood Pressure and Heart Rate in Individuals with Chronic Pain Due to Musculoskeletal System Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001452', 'term': 'Balneology'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'description': "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.\n\nBlood pressure and heart rate was evaluated with a non invasive sphygmomanometer on the same arm (right) (OMRON HBP-1320).\n\nThe pulse number was confirmed by measuring with the researcher's three fingers on the radial artery."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balneotherapy', 'Blood Pressure', 'Cardiac Rate'], 'conditions': ['Balneology', 'Blood Pressure', 'Heart Rate']}, 'descriptionModule': {'briefSummary': 'Purpose: This study aimed to investigate the effect of balneotherapy on blood pressure and heart rate in patients.\n\nMethods: A total of 240 participants who met the inclusion criteria of the study were divided into 2 groups (120 participants in each group).\n\nA 10-session physical therapy was applied to all participants in both groups. Balneotherapy was applied to Group I.\n\nThe 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.', 'detailedDescription': '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.\n\nAnswers 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.\n\nMETHODS 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.\n\nA 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.\n\nAll 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 45 and 75\n* Patients with pain associated with rheumatic diseases\n\nExclusion Criteria:\n\n* Inflammatory rheumatic disease (rheumatoid arthritis, ankylosing spondylitis, etc.),\n* Diagnosed with uncontrolled arterial hypertension and diabetes mellitus,\n* Having a diagnosed neuro-psychiatric problem,\n* Undergoing malignancy treatment,\n* Having a bleeding disease,\n* Having an infectious disease with fever,\n* Patients who received physical therapy, balneotherapy or both in the last six mounths.'}, 'identificationModule': {'nctId': 'NCT06895434', 'briefTitle': 'Effect of Repeated Thermomineral Water Immersion on Blood Pressure and Heart Rate in Individuals with Chronic Pain Due to Musculoskeletal System Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Uşak University'}, 'officialTitle': 'Does Balneotherapy Affect Blood Pressure and Pulse?', 'orgStudyIdInfo': {'id': 'Balneotherapy +Blood Pressure'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Balneotherapy with physical therapy', 'description': '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.', 'interventionNames': ['Other: Balneotherapy with physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Only physical therapy', 'description': 'Patients in group 2 were applied only a physical therapy program.', 'interventionNames': ['Other: Physical therapy']}], 'interventions': [{'name': 'Balneotherapy with physical therapy', 'type': 'OTHER', 'otherNames': ['Transcutaneous Electrical Nerve Stimulation (TENS)', 'Hot Pack', 'Ultrasound(US) Therapy'], 'description': '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.\n\nA 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.', 'armGroupLabels': ['Balneotherapy with physical therapy']}, {'name': 'Physical therapy', 'type': 'OTHER', 'otherNames': ['Transcutaneous Electrical Nerve Stimulation (TENS)', 'Hot Pack', 'Ultrasound(US) Therapy'], 'description': '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.', 'armGroupLabels': ['Only physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64200', 'city': 'Merkez', 'state': 'Uşak', 'country': 'Turkey (Türkiye)', 'facility': 'UsakU'}], 'overallOfficials': [{'name': 'Kağan Özkuk', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uşak University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uşak University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}