The Effects of Immersion in 42℃ Thermal-mineral Water on Chronic Low-back Pain

January 26, 2023 updated by: Tamas Gati, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

The Effects of Immersion in 42℃ Radon, Natrium, Calcium, Bicarbonate Content Thermal-mineral Water on Chronic Low-back Pain. Controlled, Follow-up Study

In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on clinical parameters and quality of life of patients with chronic low-back pain is evaluated. The participants in the intervention group are treated with balneotherapy plus usual care, while in the control group only with usual care. The planned participants number is 120. Follow up period is 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on clinical parameters and quality of life of patients with chronic low-back pain is evaluated. The participants in the intervention group are treated with balneotherapy plus usual care, while in the control group only with usual care. The balneotherapy takes place in Rudas Spa in Budapest, 15 times in 3 weeks. The intensity of pain in rest and during activity evaluated on Visual Analogue Scale (VAS), the Oswestry Disability Index and the Euroqol-5D is taken at week 0., at week 3. and at week 12. The planned participants number is 120. Follow up period is 3 months.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1084
        • Saint Cosmas Health Center of Joseph Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatients suffering from non-specific chronic low back pain standing for at least 12 weeks; only slightly reduced mobility (able to admit the treatments or visits on his own or without the help of another person);
  • pain intensity of low back pain during activity at least 35 on Visual Analog Scale (0-100 mm VAS); likely degenerative symptoms

Exclusion Criteria:

  • severe neurological deficit associated with the lower back;
  • suspected vertebral compression of osteoporotic or other aetiology;
  • malignancy;
  • pain due to inflammatory spinal disease;
  • severe spondylolisthesis (grade 2 or above);
  • balneotherapy within 3 months prior the enrollement
  • steroid therapy within 1 month prior the enrollement
  • and general contraindications to balneotherapy: decompensated cardiopulmonary status (unstable hypertension, earlier tromboembolia, serious arteriosclerosis obliterans, serious varicositas, etc), unbalanced endocrinological and metabolic disease, fever condition, infectious disease, extensive inflammation/injury/absence of the skin, other severe interstitial, urogenital, and other diseases, malignancy, urine and stool incontinent, decompensated psychosis and neurosis, unconsciousness, pregnancy, postoperative status, alcoholic influence, and lack of compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
usual care
Experimental: balneotherapy group
balneotherapy plus usual care
Other: balneotherapy
immersion in radon, calcium, natrium, bicarbonate content 42 ℃ thermal-mineral water 15 times in 3 weeks, plus usual care. The total mineral substance of the water is 1530 mg/l. The suggested daily time spent in water is 20 minutes altogether with breaks.
Other Names:
  • no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain during activity evaluated on Visual Analogue Scale (0-100mm)
Time Frame: 48 hours before the measuring time
The pain during activity evaluated on Visual Analogue Scale (0-100mm)
48 hours before the measuring time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain at rest evaluated on Visual Analogue Scale (0-100mm)
Time Frame: 48 hours before the measuring time
The pain at rest evaluated on Visual Analogue Scale (0-100mm)
48 hours before the measuring time
Oswestry disability index
Time Frame: through study completion, an average of 12 weeks
international questionnaire specific for back pain
through study completion, an average of 12 weeks
EuroQol 5D index and VAS
Time Frame: through study completion, an average of 12 weeks
international questionnaire evaluating the quality of life
through study completion, an average of 12 weeks
patient acceptable symptom state (PASS)
Time Frame: through study completion, an average of 12 weeks
number of patients satisfied with their condition due to low back pain
through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Investigators

  • Principal Investigator: Tamas Gati, MD PhD, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RudasCLP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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