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Completed

NCT Number: NCT05342051

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Cosmas Health Center of Joseph Town

Budapest, 1084, Hungary

About this 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

balneotherapy

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Oswestry disability index

    Time frame: through study completion, an average of 12 weeks

    international questionnaire specific for back pain

  3. EuroQol 5D index and VAS

    Time frame: through study completion, an average of 12 weeks

    international questionnaire evaluating the quality of life

  4. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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