The Effects of Immersion in 42℃ Thermal-mineral Water on Chronic Low-back Pain
NCT ID: NCT05342051
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2021-08-15
2022-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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balneotherapy group
balneotherapy plus usual care
balneotherapy
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.
control group
usual care
No interventions assigned to this group
Interventions
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balneotherapy
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pain intensity of low back pain during activity at least 35 on Visual Analog Scale (0-100 mm VAS); likely degenerative symptoms
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
OTHER
Responsible Party
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Tamas Gati
Principal Investigator
Principal Investigators
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Tamas Gati, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Locations
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Saint Cosmas Health Center of Joseph Town
Budapest, , Hungary
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RudasCLP
Identifier Type: -
Identifier Source: org_study_id
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