Shetty Sunil, Singh Shikhar, Kale Sachin, Pawar Jatin, Rayudu Veeramreddy Ts Manohar, Gehlot Ojas
Department of Orthopedics, Dr. D. Y. Patil Hospital, Navi Mumbai, Maharashtra, India.
J Orthop Case Rep. 2025 Jun;15(6):242-249. doi: 10.13107/jocr.2025.v15.i06.5726.
Low back pain (LBP) is one of the most prevalent musculoskeletal conditions, leading to significant disability and healthcare burden worldwide. Effective pain relief with minimal side effects is crucial for improving patient outcomes. Tapentadol, a dual-mechanism opioid with µ-opioid receptor agonism and norepinephrine reuptake inhibition, has shown potent analgesic effects. Intranasal administration is an emerging route that ensures rapid absorption and enhanced efficacy. However, limited real-world data exist on the clinical use of tapentadol nasal spray (NS) in LBP management. This study aimed to evaluate the effectiveness and tolerability of tapentadol NS in patients with LBP.
This investigator-initiated, retrospective, real-world, observational study analyzed data from electronic medical records of adult LBP patients ≤65 years old treated with tapentadol NS for three consecutive days. The primary endpoint was change in score on the numeric pain rating scale (NPRS). The secondary endpoints were the proportion of patients requiring rescue medicine, change in global sleep quality score, and incidence of adverse events (AEs).
A total of 300 patients were included in the analysis. The mean ± standard deviation NPRS pain score decreased significantly from 7.00 ± 0.80 on day 0 to 1.38 ± 0.45 on day 3, reflecting an 80.29% reduction (P < 0.001 for all changes from baseline). Notably, 99.00% of patients achieved >51% pain reduction by day 3. Similar trends were observed across different age groups and between male and female patients. Only 1.67% (5/300) of patients required rescue medication (intravenous paracetamol). A significant improvement in sleep quality (P < 0.001) was also noted. Importantly, no AEs were reported, indicating excellent tolerability of tapentadol NS.
Tapentadol NS demonstrated significant pain reduction and improvement in sleep quality in adult patients with LBP. The therapy was well tolerated, with no reported AEs and a minimal requirement for rescue medication. These findings suggest that tapentadol NS is an effective and safe treatment option for acute LBP. Future prospective studies with a longer follow-up period and a comparative analysis with other analgesic formulations are warranted to further establish its role in LBP management.
腰痛（LBP）是最常见的肌肉骨骼疾病之一，在全球范围内导致严重的残疾和医疗负担。以最小的副作用实现有效的疼痛缓解对于改善患者预后至关重要。曲马多是一种具有μ-阿片受体激动作用和去甲肾上腺素再摄取抑制作用的双机制阿片类药物，已显示出强大的镇痛效果。鼻内给药是一种新兴途径，可确保快速吸收并提高疗效。然而，关于曲马多鼻喷雾剂（NS）在腰痛管理中的临床应用的真实世界数据有限。本研究旨在评估曲马多NS对腰痛患者的有效性和耐受性。
这项由研究者发起的回顾性、真实世界观察性研究分析了连续三天接受曲马多NS治疗的65岁及以下成年腰痛患者电子病历中的数据。主要终点是数字疼痛评分量表（NPRS）评分的变化。次要终点是需要急救药物的患者比例、总体睡眠质量评分的变化以及不良事件（AE）的发生率。
共有300名患者纳入分析。NPRS疼痛评分的平均值±标准差从第0天的7.00±0.80显著降至第3天的1.38±0.45，反映出降低了80.29%（所有与基线相比的变化P<0.001）。值得注意的是，到第3天，99.00%的患者疼痛减轻超过51%。在不同年龄组以及男性和女性患者之间观察到类似趋势。只有1.67%（5/300）的患者需要急救药物（静脉注射对乙酰氨基酚）。睡眠质量也有显著改善（P<0.001）。重要的是，未报告任何不良事件，表明曲马多NS具有出色的耐受性。
曲马多NS在成年腰痛患者中显示出显著的疼痛减轻和睡眠质量改善。该疗法耐受性良好，未报告不良事件，且急救药物需求极少。这些发现表明曲马多NS是急性腰痛的一种有效且安全的治疗选择。未来需要进行更长随访期的前瞻性研究以及与其他镇痛制剂的对比分析，以进一步确定其在腰痛管理中的作用。
