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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
balneotherapy
Sponsored by
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring low back pain, Balneotherapy, spa therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Saint Cosmas Health Center of Joseph Town

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

balneotherapy group

control group

Arm Description

balneotherapy plus usual care

usual care

Outcomes

Primary Outcome Measures

The pain during activity evaluated on Visual Analogue Scale (0-100mm)
The pain during activity evaluated on Visual Analogue Scale (0-100mm)

Secondary Outcome Measures

The pain at rest evaluated on Visual Analogue Scale (0-100mm)
The pain at rest evaluated on Visual Analogue Scale (0-100mm)
Oswestry disability index
international questionnaire specific for back pain
EuroQol 5D index and VAS
international questionnaire evaluating the quality of life
patient acceptable symptom state (PASS)
number of patients satisfied with their condition due to low back pain

Full Information

First Posted
April 7, 2022
Last Updated
January 26, 2023
Sponsor
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
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1. Study Identification

Unique Protocol Identification Number
NCT05342051
Brief Title
The Effects of Immersion in 42℃ Thermal-mineral Water on Chronic Low-back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
low back pain, Balneotherapy, spa therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
balneotherapy group
Arm Type
Experimental
Arm Description
balneotherapy plus usual care
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
balneotherapy
Other Intervention Name(s)
no intervention
Intervention 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.
Primary Outcome Measure Information:
Title
The pain during activity evaluated on Visual Analogue Scale (0-100mm)
Description
The pain during activity evaluated on Visual Analogue Scale (0-100mm)
Time Frame
48 hours before the measuring time
Secondary Outcome Measure Information:
Title
The pain at rest evaluated on Visual Analogue Scale (0-100mm)
Description
The pain at rest evaluated on Visual Analogue Scale (0-100mm)
Time Frame
48 hours before the measuring time
Title
Oswestry disability index
Description
international questionnaire specific for back pain
Time Frame
through study completion, an average of 12 weeks
Title
EuroQol 5D index and VAS
Description
international questionnaire evaluating the quality of life
Time Frame
through study completion, an average of 12 weeks
Title
patient acceptable symptom state (PASS)
Description
number of patients satisfied with their condition due to low back pain
Time Frame
through study completion, an average of 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamas Gati, MD PhD
Organizational Affiliation
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Cosmas Health Center of Joseph Town
City
Budapest
ZIP/Postal Code
1084
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
16137981
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 2005 Aug 29.
Results Reference
result
PubMed Identifier
19197573
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.
Results Reference
result
PubMed Identifier
21947373
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 27.
Results Reference
result
PubMed Identifier
29464338
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. doi: 10.1007/s00484-018-1505-7.
Results Reference
result
PubMed Identifier
31517832
Citation
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.
Results Reference
result
PubMed Identifier
16449365
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.
Results Reference
result
PubMed Identifier
25535198
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.
Results Reference
result
PubMed Identifier
34625843
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 Oct 9.
Results Reference
result

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

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