Pain research & management · 2026
Spinal Cord Stimulation for Painful Diabetic Neuropathy: A Systematic Review and Meta-Analysis of High- and Low-Frequency Modalities.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Liu Chengjiang, Xu Zidi, Liang Yifu, Luo Yujia, Zheng Siyao, Ye Zhikang, Feng Zhiying
Аннотация
OBJECTIVE: To systematically evaluate the efficacy and safety of high-frequency (HF-SCS) and low-frequency (LF-SCS) spinal cord stimulation for painful diabetic neuropathy (PDN) and to qualitatively explore potential differences between HF-SCS and LF-SCS based on indirect comparisons.
METHODS: A systematic review and meta-analysis were conducted following PRISMA guidelines. We searched PubMed, Scopus, Embase, Web of Science, and the Cochrane Library for studies published between 2015 and 2024. Inclusion criteria included studies involving adult patients with PDN receiving either HF-SCS or LF-SCS. Eligible studies reported outcomes such as pain relief VAS, EQ-5D, and adverse events. Data were analyzed using a random-effects model. Pain intensity outcomes were converted to a 0-10 scale and pooled as mean differences (MDs). The EQ-5D index was pooled as standardized mean differences (SMDs). Sensitivity and subgroup analyses were performed to assess heterogeneity.
RESULTS: In total, 9 studies, including 416 participants, were eligible. Moderate certainty evidence suggests that both HF-SCS and LF-SCS significantly reduce pain in patients with PDN. In RCTs, SCS reduced pain at 6 months compared with best medical therapy (overall MD on a 0-10 scale: -3.95, 95% CI -5.57 to -2.33). In subgroup analyses, the HF-SCS trial showed an MD of -5.20 (95% CI -5.79 to -4.61), and LF-SCS trials showed a pooled MD of -3.22 (95% CI -4.37 to -2.07). Both treatments were associated with low adverse event rates.
CONCLUSION: Both HF-SCS and LF-SCS were associated with substantial reductions in pain intensity in patients with PDN compared with best medical therapy or baseline, although the overall certainty of evidence was at most moderate. Because no head-to-head trials directly comparing HF-SCS and LF-SCS in PDN were available, comparative effectiveness between modalities remains uncertain; however, these cross-study differences should be interpreted cautiously because the modalities were not compared head-to-head. Improvements in EQ-5D were modest and did not consistently exceed the prespecified minimal important difference, and both modalities showed low rates of mainly device-related complications with few serious adverse events reported.
METHODS: A systematic review and meta-analysis were conducted following PRISMA guidelines. We searched PubMed, Scopus, Embase, Web of Science, and the Cochrane Library for studies published between 2015 and 2024. Inclusion criteria included studies involving adult patients with PDN receiving either HF-SCS or LF-SCS. Eligible studies reported outcomes such as pain relief VAS, EQ-5D, and adverse events. Data were analyzed using a random-effects model. Pain intensity outcomes were converted to a 0-10 scale and pooled as mean differences (MDs). The EQ-5D index was pooled as standardized mean differences (SMDs). Sensitivity and subgroup analyses were performed to assess heterogeneity.
RESULTS: In total, 9 studies, including 416 participants, were eligible. Moderate certainty evidence suggests that both HF-SCS and LF-SCS significantly reduce pain in patients with PDN. In RCTs, SCS reduced pain at 6 months compared with best medical therapy (overall MD on a 0-10 scale: -3.95, 95% CI -5.57 to -2.33). In subgroup analyses, the HF-SCS trial showed an MD of -5.20 (95% CI -5.79 to -4.61), and LF-SCS trials showed a pooled MD of -3.22 (95% CI -4.37 to -2.07). Both treatments were associated with low adverse event rates.
CONCLUSION: Both HF-SCS and LF-SCS were associated with substantial reductions in pain intensity in patients with PDN compared with best medical therapy or baseline, although the overall certainty of evidence was at most moderate. Because no head-to-head trials directly comparing HF-SCS and LF-SCS in PDN were available, comparative effectiveness between modalities remains uncertain; however, these cross-study differences should be interpreted cautiously because the modalities were not compared head-to-head. Improvements in EQ-5D were modest and did not consistently exceed the prespecified minimal important difference, and both modalities showed low rates of mainly device-related complications with few serious adverse events reported.