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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: balneotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balneotherapy group<br>balneotherapy plus usual care | Other: balneotherapy<br>* 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.<br>* Other names: no intervention;|
| No Intervention: control group<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, Balneotherapy, spa therapy