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

NCT05342051 | Completed

• 1 other identifier: RudasCLP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

low back pain; Balneotherapy; spa therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The pain at rest evaluated on Visual Analogue Scale (0-100mm)

  48 hours before the measuring time

• Oswestry disability index

  through study completion, an average of 12 weeks

• EuroQol 5D index and VAS

  through study completion, an average of 12 weeks

• patient acceptable symptom state (PASS)

  through study completion, an average of 12 weeks

Study Arms (2)

balneotherapy group

EXPERIMENTAL

balneotherapy plus usual care

Other: balneotherapy

control group

NO INTERVENTION

usual care

Interventions

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.

Also known as: no intervention

balneotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polyclinic of the Hospitaller Brothers of St. John of God, Budapest: lead

Study Sites (1)

Saint Cosmas Health Center of Joseph Town

Budapest, 1084, Hungary

Location

Related Publications (9)

• 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.

  PMID: 16137981 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.

  PMID: 19197573 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.

  PMID: 21947373 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.

  PMID: 29464338 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.

  PMID: 31517832 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.

  PMID: 16449365 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.

  PMID: 25535198 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.

  PMID: 34625843 RESULT

• 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.

  PMID: 36708381 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Balneology

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tamas Gati, MD PhD

  Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 22, 2022
• Study Start: August 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 15, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

HU (1)