Chronic Low-back Pain
Conditions
Keywords
low back pain, Balneotherapy, spa therapy
Brief summary
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
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.
Interventions
OTHERbalneotherapy
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.
Sponsors
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The pain during activity evaluated on Visual Analogue Scale (0-100mm) | 48 hours before the measuring time | The pain during activity evaluated on Visual Analogue Scale (0-100mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pain at rest evaluated on Visual Analogue Scale (0-100mm) | 48 hours before the measuring time | The pain at rest evaluated on Visual Analogue Scale (0-100mm) |
| Oswestry disability index | through study completion, an average of 12 weeks | international questionnaire specific for back pain |
| EuroQol 5D index and VAS | through study completion, an average of 12 weeks | international questionnaire evaluating the quality of life |
| patient acceptable symptom state (PASS) | through study completion, an average of 12 weeks | number of patients satisfied with their condition due to low back pain |
Countries
Hungary
Outcome results
None listed