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

NCT06895434 | Completed

• 1 other identifier: Balneotherapy +Blood Pressure
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Balneology; Blood Pressure; Heart Rate

Keywords

Balneotherapy; Blood Pressure; Cardiac Rate

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Study Arms (2)

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.

Other: Balneotherapy with physical therapy

Only physical therapy

ACTIVE COMPARATOR

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

Other: Physical therapy

Interventions

Balneotherapy with physical therapy 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.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy

Balneotherapy with physical therapy

Physical therapy 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.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack, Ultrasound(US) Therapy

Only physical therapy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 45 and 75
• Patients with pain associated with rheumatic diseases

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uşak University: lead
• Abant Izzet Baysal University: collaborator

Study Sites (1)

UsakU

Merkez, Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Balneology; Physical Therapy Modalities; Transcutaneous Electric Nerve Stimulation; Therapeutics

Intervention Hierarchy (Ancestors)

Rehabilitation; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Kağan Özkuk

  Uşak University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 26, 2025
• Study Start: February 7, 2020
• Primary Completion: May 27, 2020
• Study Completion: July 30, 2020
• Last Updated: March 26, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)