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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balneotherapy group | Experimental | balneotherapy plus usual care |
|
| control group | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamas Gati, MD PhD | Polyclinic of the Hospitaller Brothers of St. John of God, Budapest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Cosmas Health Center of Joseph Town | Budapest | 1084 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16137981 | Result | Balogh Z, Ordogh J, Gasz A, Nemet L, Bender T. Effectiveness of balneotherapy in chronic low back pain -- a randomized single-blind controlled follow-up study. Forsch Komplementarmed Klass Naturheilkd. 2005 Aug;12(4):196-201. doi: 10.1159/000086305. Epub 2005 Aug 29. | |
| 19197573 | Result | Kulisch A, Bender T, Nemeth A, Szekeres L. Effect of thermal water and adjunctive electrotherapy on chronic low back pain: a double-blind, randomized, follow-up study. J Rehabil Med. 2009 Jan;41(1):73-9. doi: 10.2340/16501977-0291. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001452 | Balneology |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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|
| 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 |
| 21947373 | Result | Tefner IK, Nemeth A, Laszlofi A, Kis T, Gyetvai G, Bender T. The effect of spa therapy in chronic low back pain: a randomized controlled, single-blind, follow-up study. Rheumatol Int. 2012 Oct;32(10):3163-9. doi: 10.1007/s00296-011-2145-y. Epub 2011 Sep 27. |
| 29464338 | Result | Gati T, Tefner IK, Kovacs L, Hodosi K, Bender T. Correction to: The effects of the calcium-magnesium-bicarbonate content in thermal mineral water on chronic low back pain: a randomized, controlled follow-up study. Int J Biometeorol. 2018 May;62(5):907. doi: 10.1007/s00484-018-1505-7. |
| 31517832 | Result | Bai R, Li C, Xiao Y, Sharma M, Zhang F, Zhao Y. Effectiveness of spa therapy for patients with chronic low back pain: An updated systematic review and meta-analysis. Medicine (Baltimore). 2019 Sep;98(37):e17092. doi: 10.1097/MD.0000000000017092. |
| 16449365 | Result | Pittler MH, Karagulle MZ, Karagulle M, Ernst E. Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials. Rheumatology (Oxford). 2006 Jul;45(7):880-4. doi: 10.1093/rheumatology/kel018. Epub 2006 Jan 31. |
| 25535198 | Result | Karagulle M, Karagulle MZ. Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence. Clin Rheumatol. 2015 Feb;34(2):207-14. doi: 10.1007/s10067-014-2845-2. Epub 2014 Dec 23. |
| 34625843 | Result | Forestier R, Fioravanti A, Bender T, Santos I, Erol Forestier FB, Muela Garcia A, Francon A. Crenobalneotherapy for low back pain: systematic review of clinical trials. Int J Biometeorol. 2022 Jan;66(1):13-23. doi: 10.1007/s00484-021-02188-9. Epub 2021 Oct 9. |
| 36708381 | Derived | Tefner IK, Bender T, Kleiber J, Hodosi K, Gati T. The effects of immersion in 42℃ radon, natrium, calcium, bicarbonate content thermal-mineral water on chronic low back pain. Controlled, follow-up study. Int J Biometeorol. 2023 Mar;67(3):527-537. doi: 10.1007/s00484-023-02433-3. Epub 2023 Jan 28. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |