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Does transcutaneous Vagus Nerve Stimulation (tVNS) reduce pain intensity in chronic low back pain patients? A randomized controlled pilot study

  • Muhammad Jasman Erwin Halim ,
  • Lydia Arfianti ,
  • I Putu Alit Pawana ,
  • Soenarnatalina Melaniani ,

Abstract

Background: Low back pain, if poorly treated, is responsible for a decline in patients’ quality of life. In addition to medication and exercise therapy, transcutaneous vagus nerve stimulation (tVNS) emerges as one of the modalities for chronic pain. Currently, studies on the effect of tVNS on pain intensity, particularly in chronic low back pain cases, are still scarce. This study aims to examine the effect of tVNS in addition to exercise treatment on patients with chronic low back pain.

Methods: Twenty-two patients were randomly assigned to one of two groups: the control group, which included eleven patients who received only exercise therapy, and the intervention group, which included eleven patients who received exercise therapy with tVNS as an additional therapy. The demographic data of the participants and the results of the Numerical Pain Rating Scale (NPRS) were used as outcome measures. Data were collected before and after the two-week treatment period. Safety and adverse events were monitored throughout the study.

Results: The mean NPRS decreased in both groups, with the intervention group decreasing from 5.45 to 1.73 (p < 0.001) and the control group decreasing from 5.82 to 3.27 (p < 0.001). Although the intervention group's average NPRS score decreased more than the control groups, no significant difference was found (p=1.04). Following Cohen's D, the effect size of the intervention group was more significant (2.22) than that of the control group (1.62).

Conclusion: These findings imply that tVNS should be considered an additional therapy for chronic low back pain patients. During the study, no side effects were discovered.

References

  1. Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, et al. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016;5:F1000.
  2. Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, et al. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020;8(6):299.
  3. Duthey, Beatrice. Update on 2004 Background Paper, BP 6.24 Low Back Pain. Priority Medicines for Europe and the World. A Public Health Approach to Innovation: World Health Organization. 2013;6:1-74.
  4. Fitrina, Ruhaya. Low Back Pain. Kementerian Kesehatan Republik Indonesia. 2018.
  5. Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021;398(10294):78-92.
  6. Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain. 2015;16(1):1-9
  7. Holle-Lee D, Gaul C. Non-invasive vagus nerve stimulation in the management of cluster headache: clinical evidence and practical experience. Ther Adv Neurol Disord. 2016;9(3):230-234.
  8. Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018;11:203-213.
  9. Farmer AD, Strzelczyk A, Finisguerra A , Gourine AV, et al. International consensus based review and recommendations for minimum reporting standards in research on transcutaneous vagus nerve stimulation. Frontiers in human neuroscience. 2021;14:568051.
  10. Badran BW, Yu AB, Adair D, et al. Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. J Vis Exp. 2019;143:e58984.
  11. Leung L, Cahill CM. TNF-alpha and neuropathic pain--a review. J Neuroinflammation. 2010;7(1):1-11
  12. American College of Sports Medicine. ACSM's guidelines for exercise testing and prescription 10th edition. Lippincott Williams & Wilkins. 2018.
  13. Kutlu N, Özden AV, Alptekin HK, Alptekin JÖ. The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome. Biomed Res Int. 2020;2020:8656218.
  14. Hein E, Nowak M, Kiess O, Biermann T, Bayerlein K, Kornhuber J, et al. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm (Vienna). 2013;120(5):821-827.
  15. Lazaridou A, Elbaridi N, Edwards RR, Berde CB. Pain assessment. Essentials of pain medicine: 4th Edition. 2018;39-46.
  16. Aranow C, Atish-Fregoso Y, Lesser M, Mackay M, Anderson E, Chavan S, et al. Transcutaneous auricular vagus nerve stimulation reduces pain and fatigue in patients with systemic lupus erythematosus: a randomised, double-blind, sham-controlled pilot trial. Ann Rheum Dis. 2021;80(2):203-208.
  17. Courties A, Deprouw C, Rousseau A, Berard L, Touati A, Kalsch J, et al. Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial. BMJ Open. 2022;12(3):e056169.
  18. Marsal S, Corominas H, De Agustin De Oro J, Perez Garcia C, Lopez Lasanta M, Borrell H, et al. Non-invasive Vagus Nerve Stimulation Improves Signs and Symptoms of Rheumatoid Arthritis: Results of a Pilot Study [abstract]. Arthritis Rheumatol. 2020; 72 (10):1-10.
  19. Tarn J, Legg S, Mitchell S, Simon B, Ng WF. The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjögren's Syndrome. Neuromodulation. 2019;22(5):580-585.
  20. van der Velde G, Mierau D. The effect of exercise on percentile rank aerobic capacity, pain, and self-rated disability in patients with chronic low-back pain: a retrospective chart review. Arch Phys Med Rehabil. 2000;81(11):1457-1463.
  21. Câmara-Gomes LF, Dibai Filho AV, Diniz RR, Alvares PD, Veneroso CE, Cabido CET. Mechanisms of muscle stretching exercises for reduction of low back pain: narrative review. Brazilian Journal of Pain. 2022;5(1):52-55.
  22. Taimela S, Diederich C, Hubsch M, Heinricy M. The role of physical exercise and inactivity in pain recurrence and absenteeism from work after active outpatient rehabilitation for recurrent or chronic low back pain: a follow-up study. Spine (Phila Pa 1976). 2000;25(14):1809-1816.
  23. Leggett S, Mooney V, Matheson LN, Nelson B, Dreisinger T, Van Zytveld J, et al. Restorative exercise for clinical low back pain. A prospective two-center study with 1-year follow-up. Spine (Phila Pa 1976). 1999;24(9):889-898.
  24. Yap JYY, Keatch C, Lambert E, Woods W, Stoddart PR, Kameneva T. Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice. Front Neurosci. 2020;14:284.
  25. Soumena RZ, Darma A, Ranuh RG, Indra Gunawan P, Fardah Athiyyah A, Rizky Sumitro K, et al. Efficacy of transcutaneous electrical nerve stimulation on slow transit constipation in children with cerebral palsy. Bali Medical Journal. 2023;12(1):192–196.
  26. Suyasa IK, Lestari AAW, Prabawa IPY, Marta KKA. Water Sport-Related Spine Injury in Bali: A Review and Preliminary Study. Indonesia Journal of Biomedical Science. 2019;13(2):72-76.

How to Cite

Muhammad Jasman Erwin Halim, Arfianti, L., Pawana, I. P. A., & Melaniani, S. (2023). Does transcutaneous Vagus Nerve Stimulation (tVNS) reduce pain intensity in chronic low back pain patients? A randomized controlled pilot study. Bali Medical Journal, 12(1), 423–428. https://doi.org/10.15562/bmj.v12i1.3929

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Muhammad Jasman Erwin Halim
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Lydia Arfianti
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I Putu Alit Pawana
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Soenarnatalina Melaniani
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