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

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

Status

Completed

Conditions

Chronic Low-back Pain

Treatments

Other: balneotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05342051

RudasCLP

Details and patient eligibility

About

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.