Volume 10 Issue 1

Effects of Oral Ingestion of L-Ornithine on Mental Stress and Fatigue Based on the Trier Social Stress Test in Healthy Humans: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

Kazuki Moriyasu,Atsushi Nakajima andMasahiko Morita

1Department of Physical Medicine and Rehabilitation, CHU Montpellier, University of Montpellier, 34295 Montpellier, France
2Centre d’Investigation Clinique, CHU Montpellier Montpellier, Inserm, CIC 1411, 34295 Montpellier, France
3IRMB, University of Montpellier, INSERM, 34295 Montpellier, France
4Clinical Immunology and Osteoarticular Diseases Therapeutic Unit, Lapeyronie University Hospital, CHU Montpellier, 34295 Montpellier, France

Abstract

Background/Objectives: Chronic low back pain (CLBP) is a common condition with limited long-term treatment options. Vagus nerve stimulation (VNS) has shown potential for pain improvement, but its use in CLBP remains underexplored. Our aim was to evaluate the efficacy, feasibility and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing pain and improving functional outcomes in CLBP patients. Methods: Thirty adults with CLBP (VAS ≥ 40/100) participated in this open-label pilot study (NCT05639270). Patients were treated with a taVNS device on the left ear for 30 min daily over a period of 3 months. The primary outcome was a reduction in pain intensity (VAS) at 1 month. Secondary outcomes included pain intensity at 3 months, disability (Oswestry Disability Index, ODI), quality of life (EQ-5D-5L), catastrophizing and psychological distress. In addition, compliance and adverse events were monitored. Results: After 1 month, 27 patients were evaluated. VAS scores decreased significantly by 16.1 (SD = 17.9) mm (p < 0.001) and by 22.5 (25) mm (p < 0.001) after 3 months (24 patients were analyzed). Functional disability improved with an average reduction in ODI of 11.9 (11.1) points (p < 0.001) after 3 months. Other patient-reported outcomes also improved significantly over the 3-month period. Overall, 51.9% of the patients achieved clinically meaningful pain reduction (≥20 mm), and no serious adverse events were reported. Treatment adherence was good, with half of the patients achieving 80% adherence. Conclusions: This pilot study suggests that taVNS is a feasible, safe and potentially effective treatment for CLBP that warrants further investigation in a randomized controlled trial compared to sham stimulation.
Keywords: 
vagus nerve stimulation; chronic low back pain; pain; disability; non-pharmacological therapy
Scroll to Top