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Effects of balneological outpatient treatment on clinical parameters and serum cytokine levels in patients with chronic low back pain: a single-blind randomized controlled trial

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Abstract

This study aimed to investigate the effects of balneological outpatient treatment (hydrotherapy and peloidotherapy) on clinical status and serum cytokine levels in patients with chronic low back pain (CLBP). Seventy-four patients with CLBP who accepted to participate to the study were randomly divided into two groups. The study group was given ten sessions (in 2 weeks) of hydrotherapy, peloidotherapy, and home exercise, while the control group was given only home exercise. All patients were assessed before and at the end of therapy, at the 1st and 3rd months. The primary outcomes were pain intensity on the visual analog scale (VAS) (VAS-pain, VAS-rest, VAS-exercise) and Oswestry Disability Index (ODI). The secondary outcome measures included patient’s and physician’s global assessment (VAS-PGA), (VAS-DGA), finger-to-floor distance (FFD), modified Schober test, Short Form-36 (SF-36), and the use of analgesic drug. Venous blood samples were drawn from all patients before/1st day and after therapy/12th day to measure serum interleukin (IL)-6 and IL-10 levels. Significant improvement was observed in the study group in VAS-pain, VAS-rest, VAS-exercise, VAS-PGA, VAS-DGA, ODI, and SF-36 parameters after treatment and improvement maintained for 3 months. In the control group, significant improvement was observed in VAS-pain, VAS-exercise, VAS-PGA, VAS-DGA, and ODI scores on the 12th day and continued for 3 months. Decrease in pain, pain during rest and exercise, modified Schober test, VAS-PGA, VAS-DGA, ODI scores, and the increase in SF-36 pain and general health scores showed superiority in favor of the study group in all evaluations. There was a significant increase in IL-10 values from baseline at the end of treatment in the study group. The use of non-steroidal anti-inflammatory drug (NSAID) was significantly lower in the study group compared with the use of NSAID in the control group in the 3rd month. Balneological outpatient treatment improved clinical status in CLBP patients. Although no significant correlation was clearly determined between IL-10 levels and pain score, this effect might be related to the observed increase in the anti-inflammatory cytokine IL-10 levels that was observed only in the study group.

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Funding

Scientific Research Projects Coordination Unit of Istanbul University (BAP), Project number: TTU-2018-31745.

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Authors and Affiliations

  1. Department of Medical Ecology and Hydroclimatology, Antalya Education and Research Hospital, University of Health Sciences, Varlık Mh. Kazım Karabekir Cd., 07100 Muratpaşa, Antalya, Turkey

    H. Yücesoy & E. Atmaca-Aydın

  2. Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Fatih, Çapa, Istanbul, Turkey

    A. Dönmez, N. Erdoğan & M. Z. Karagülle

  3. Department of Physiology, Istanbul Faculty of Medicine, Istanbul University, Fatih, Çapa, 34093, Istanbul, Turkey

    S. P. Yentür & G. Saruhan-Direskeneli

  4. Department of Biostatistics and Medical Informatics, Istanbul Medeniyet University Medical Faculty, 34093, Kadıköy, Turkey

    H. Ankaralı

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  1. H. Yücesoy
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  2. A. Dönmez
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  3. E. Atmaca-Aydın
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  4. S. P. Yentür
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  5. G. Saruhan-Direskeneli
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  6. H. Ankaralı
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  7. N. Erdoğan
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  8. M. Z. Karagülle
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Correspondence to H. Yücesoy.

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Ethical approval

This study was approved by Istanbul Faculty of Medicine Clinical Research Ethics Committee and the Ministry of Health of the Republic of Turkey. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Yücesoy, H., Dönmez, A., Atmaca-Aydın, E. et al. Effects of balneological outpatient treatment on clinical parameters and serum cytokine levels in patients with chronic low back pain: a single-blind randomized controlled trial. Int J Biometeorol 65, 1367–1376 (2021). https://doi.org/10.1007/s00484-021-02109-w

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