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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342051
• Other study ID #: RudasCLP
• Status: Completed
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: January 2023
• Source: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 15, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Hungary	Saint Cosmas Health Center of Joseph Town	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Country where clinical trial is conducted

Hungary, 

References & Publications (8)

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. — View Citation

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 — View Citation

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 Oc — View Citation

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. do — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Oswestry disability index	international questionnaire specific for back pain	through study completion, an average of 12 weeks
Secondary	EuroQol 5D index and VAS	international questionnaire evaluating the quality of life	through study completion, an average of 12 weeks
Secondary	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