Department of Anesthesia and Critical Care Medicine, Institute of Pain Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Department of Physical Therapy, Sagol School of Neuroscience, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Eur J Pain. 2022 Oct;26(9):1849-1862. doi: 10.1002/ejp.2002. Epub 2022 Jul 7.
The effectiveness and long-term outcomes of spinal cord stimulation (SCS) are not fully established, especially considering that data from patients who withdrew from the trial are rarely analysed, which may lead to overestimation of SCS efficacy. We evaluated short- and long-term effects of SCS on chronic pain and perceived health, beyond natural variability in these outcomes.
In a prospective design, 176 chronic pain patients referred to SCS were evaluated five times (baseline; retest ~6 weeks later; post-SCS trial; 8 and 28 weeks post-permanent implantation). Patients whose SCS trial failed (Temp group) were followed up and compared to those who underwent permanent SCS (Perm group).
Analyses revealed a non-linear (U-shaped) trend significantly different between the two groups. In the Perm group, a significant improvement occurred post-SCS implantation in pain severity, pain interference, health-related quality of life and self-rated health, which was followed by gradual worsening and return to baseline values at end of follow-up. In the Temp group, only minor changes occurred in these outcomes over time. On average, baseline and end of follow-up values in the Perm and Temp groups were similar: ~40% in each group exhibited an increase in pain severity over time and 38% and 33%, respectively, exhibited reductions in pain severity over time.
Since the greatest improvement in the outcome measures occurred from baseline to post-SCS trial (T1-T3) followed by a gradual decline in the effect, it appears that SCS may not be effective for the majority of chronic pain patients.
This longitudinal study evaluated short and long term effects of spinal cord stimulation (SCS) on chronic pain outcome measures, beyond their natural variation in time. Despite significant short term improvements, by the end of the seven months' follow-up, the outcomes in the treatment group (people who received the permanent implantation) were similar to those of the control group (people whose SCS trial failed and did not continue to permanent implantation) suggesting SCS may not be cost-effective for chronic pain patients.
脊髓刺激（SCS）的有效性和长期结果尚不完全确定，特别是考虑到很少对退出试验的患者的数据进行分析，这可能导致对 SCS 疗效的高估。我们评估了 SCS 对慢性疼痛和感知健康的短期和长期影响，超出了这些结果的自然变化。
采用前瞻性设计，对 176 名接受 SCS 治疗的慢性疼痛患者进行了 5 次评估（基线；大约 6 周后进行重测；SCS 试验后；永久植入后 8 周和 28 周）。将 SCS 试验失败的患者（Temp 组）进行随访，并与接受永久 SCS 的患者（Perm 组）进行比较。
分析显示两组之间存在显著不同的非线性（U 型）趋势。在 Perm 组中，SCS 植入后疼痛严重程度、疼痛干扰、健康相关生活质量和自我评估健康状况显著改善，随后逐渐恶化，并在随访结束时恢复到基线值。在 Temp 组中，这些结果随时间的变化仅发生较小的变化。平均而言，Perm 组和 Temp 组的基线和随访结束时的值相似：在每组中，约 40%的患者疼痛严重程度随时间增加，分别有 38%和 33%的患者疼痛严重程度随时间减轻。
由于从基线到 SCS 试验（T1-T3）的结果测量值改善最大，随后效应逐渐下降，因此 SCS 对大多数慢性疼痛患者可能无效。
这项纵向研究评估了脊髓刺激（SCS）对慢性疼痛结果测量的短期和长期影响，超出了时间上的自然变化。尽管短期有显著改善，但在七个月的随访结束时，治疗组（接受永久植入的患者）的结果与对照组（SCS 试验失败且未继续接受永久植入的患者）相似，这表明 SCS 对慢性疼痛患者可能没有成本效益。
