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Peer-reviewedCC BY 4.0Frontiers in Neurology

Needle-knife lumbosacral therapy for lumbar disc herniation: a single-center, outcome assessor-blinded randomized controlled trial

  • Yiming Zhang1
  • Ruiguo Li1
  • Xiaohong Zhang1
  • Zhanyou Wang1
  • Ziwei Zhang2
  • Huanhuan Xu2
  • Xiaofan Li2
  1. 1College of Acupuncture and Massage, Henan University of Chinese Medicine
  2. 2The Third Affiliated Hospital of Henan University of Chinese Medicine
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Abstract

Background: Lumbar disc herniation (LDH) is a common spinal disorder causing significant pain and dysfunction. Traditional acupuncture is a widely used non-pharmacological treatment for LDH. Recently, needle-knife therapy has emerged as a potential alternative.

Objective: This study aims to explore the clinical efficacy of needle-knife lumbosacral therapy for LDH and compare its advantages with those of conventional acupuncture therapy.

Methods: This study adopted an outcome assessor-blinded randomized controlled trial design. A total of 74 patients with LDH were enrolled and randomly assigned to the experimental group ( n = 37), which received needle-knife lumbosacral therapy, or the control group ( n = 37), which received conventional acupuncture at the same anatomical treatment sites. Seventy patients completed the 2-week treatment and 3-month follow-up. Visual analog scale (VAS) and Oswestry Disability Index (ODI) were designated as primary repeated outcomes; lumbar flexion mobility (LFM) was a secondary repeated outcome, and inflammatory cytokines served as non-repeated secondary outcomes. Mixed-effects linear models were used for repeated measurements, with the group-by-time interaction predefined as the primary estimand. Bonferroni correction was applied for the three repeated outcomes (VAS, ODI, and three LFM components), setting an adjusted significance threshold of α = 0.017. Unadjusted α = 0.05 was adopted for inflammatory cytokines. VAS, ODI, and LFM were evaluated at baseline, post-treatment, and 3-month follow-up; inflammatory markers (TNF-α, IL-6, IL-1β) were detected at baseline and post-treatment only. Adverse events were monitored throughout the trial. Patient recruitment was conducted from March 15, 2025, to July 15, 2025, and the final follow-up was performed on November 18, 2025.

Results: Both groups demonstrated within-group reductions in VAS and ODI scores across all time points. For the prespecified group-by-time interaction analyses under Bonferroni correction ( α = 0.017), the needle-knife group showed significantly larger longitudinal improvements than the acupuncture group for both primary outcomes: VAS interaction (95% CI: 0.21–0.83), adjusted p = 0.001; ODI interaction (95% CI: 1.89–4.35), adjusted p < 0.0001. At post-treatment, the model-based between-group differences (needle-knife minus acupuncture) were VAS: −1.16 (95% CI: −1.78 to −0.54), adjusted p = 0.0004; ODI: −3.78 (95% CI: −4.95 to −2.61), adjusted p < 0.0001. At 3-month follow-up, sustained between-group differences were VAS: −0.43 (95% CI: −0.68 to −0.18), adjusted p = 0.001; ODI: −1.89 (95% CI: −2.56 to −1.22), adjusted p < 0.0001. For LFM components, all three subindices showed greater numerical improvements in the needle-knife group, but their group-by-time interaction adjusted p -values exceeded the 0.017 threshold: lumbar flexion (95% CI: 0.62–5.00), adjusted p = 0.034; left lateral flexion (95% CI: −1.02 to 2.42), adjusted p = 0.423; right lateral flexion (95% CI: −1.10 to 1.92), adjusted p = 0.594. Among serum inflammatory biomarkers, only IL-6 showed a statistically significant unadjusted between-group difference at post-treatment: IL-6 difference = −0.47 ng·L (95% CI: −0.89 to −0.05), unadjusted p = 0.03; TNF-α difference = −0.18 ng·L (95% CI: −0.52 to 0.16), unadjusted p = 0.30; IL-1β difference = −0.13 ng·L (95% CI: −0.37 to 0.11), unadjusted p = 0.28. No serious adverse events were reported.

Conclusion: Two-week lumbosacral needle-knife therapy effectively relieves pain and lumbar dysfunction in LDH patients, with statistically verified sustained superiority over conventional acupuncture for VAS and ODI under the Bonferroni-adjusted threshold ( α = 0.017). Although numerical advantages in lumbar mobility were observed in the needle-knife group, these differences did not reach the prespecified adjusted significance level after multiple testing correction. As an outcome assessor-blinded exploratory trial with unmasked participants and therapists, large-sample and multicenter clinical studies are needed to further verify the conclusions, and future trials should optimize blinding schemes to reduce reporting bias.

Clinical trial registration: https://itmctr.ccebtcm.org.cn/mgt/project/user/approved-list , identifier (ITMCTR2025002191).

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Cite

BibTeXRIS
BibTeX
@article{zhang2026needleknife,
  title = {{Needle-knife lumbosacral therapy for lumbar disc herniation: a single-center, outcome assessor-blinded randomized controlled trial}},
  author = {Yiming Zhang and Ruiguo Li and Xiaohong Zhang and Zhanyou Wang and Ziwei Zhang and Huanhuan Xu and Xiaofan Li},
  journal = {Frontiers in Neurology},
  year = {2026},
  month = oct,
  doi = {10.3389/fneur.2026.1898714},
  url = {https://www.frontiersin.org/articles/10.3389/fneur.2026.1898714/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Needle-knife lumbosacral therapy for lumbar disc herniation: a single-center, outcome assessor-blinded randomized controlled trial
AU  - Yiming Zhang
AU  - Ruiguo Li
AU  - Xiaohong Zhang
AU  - Zhanyou Wang
AU  - Ziwei Zhang
AU  - Huanhuan Xu
AU  - Xiaofan Li
PY  - 2026
DA  - 2026/10/16
JO  - Frontiers in Neurology
DO  - 10.3389/fneur.2026.1898714
UR  - https://www.frontiersin.org/articles/10.3389/fneur.2026.1898714/full
AB  - Background: Lumbar disc herniation (LDH) is a common spinal disorder causing significant pain and dysfunction. Traditional acupuncture is a widely used non-pharmacological treatment for LDH. Recently, needle-knife therapy has emerged as a potential alternative.  Objective: This study aims to explore the clinical efficacy of needle-knife lumbosacral therapy for LDH and compare its advantages with those of conventional acupuncture therapy.  Methods: This study adopted an outcome assessor-blinded randomized controlled trial design. A total of 74 patients with LDH were enrolled and randomly assigned to the experimental group ( n = 37), which received needle-knife lumbosacral therapy, or the control group ( n = 37), which received conventional acupuncture at the same anatomical treatment sites. Seventy patients completed the 2-week treatment and 3-month follow-up. Visual analog scale (VAS) and Oswestry Disability Index (ODI) were designated as primary repeated outcomes; lumbar flexion mobility (LFM) was a secondary repeated outcome, and inflammatory cytokines served as non-repeated secondary outcomes. Mixed-effects linear models were used for repeated measurements, with the group-by-time interaction predefined as the primary estimand. Bonferroni correction was applied for the three repeated outcomes (VAS, ODI, and three LFM components), setting an adjusted significance threshold of α = 0.017. Unadjusted α = 0.05 was adopted for inflammatory cytokines. VAS, ODI, and LFM were evaluated at baseline, post-treatment, and 3-month follow-up; inflammatory markers (TNF-α, IL-6, IL-1β) were detected at baseline and post-treatment only. Adverse events were monitored throughout the trial. Patient recruitment was conducted from March 15, 2025, to July 15, 2025, and the final follow-up was performed on November 18, 2025.  Results: Both groups demonstrated within-group reductions in VAS and ODI scores across all time points. For the prespecified group-by-time interaction analyses under Bonferroni correction ( α = 0.017), the needle-knife group showed significantly larger longitudinal improvements than the acupuncture group for both primary outcomes: VAS interaction (95% CI: 0.21–0.83), adjusted p = 0.001; ODI interaction (95% CI: 1.89–4.35), adjusted p < 0.0001. At post-treatment, the model-based between-group differences (needle-knife minus acupuncture) were VAS: −1.16 (95% CI: −1.78 to −0.54), adjusted p = 0.0004; ODI: −3.78 (95% CI: −4.95 to −2.61), adjusted p < 0.0001. At 3-month follow-up, sustained between-group differences were VAS: −0.43 (95% CI: −0.68 to −0.18), adjusted p = 0.001; ODI: −1.89 (95% CI: −2.56 to −1.22), adjusted p < 0.0001. For LFM components, all three subindices showed greater numerical improvements in the needle-knife group, but their group-by-time interaction adjusted p -values exceeded the 0.017 threshold: lumbar flexion (95% CI: 0.62–5.00), adjusted p = 0.034; left lateral flexion (95% CI: −1.02 to 2.42), adjusted p = 0.423; right lateral flexion (95% CI: −1.10 to 1.92), adjusted p = 0.594. Among serum inflammatory biomarkers, only IL-6 showed a statistically significant unadjusted between-group difference at post-treatment: IL-6 difference = −0.47 ng·L (95% CI: −0.89 to −0.05), unadjusted p = 0.03; TNF-α difference = −0.18 ng·L (95% CI: −0.52 to 0.16), unadjusted p = 0.30; IL-1β difference = −0.13 ng·L (95% CI: −0.37 to 0.11), unadjusted p = 0.28. No serious adverse events were reported.  Conclusion: Two-week lumbosacral needle-knife therapy effectively relieves pain and lumbar dysfunction in LDH patients, with statistically verified sustained superiority over conventional acupuncture for VAS and ODI under the Bonferroni-adjusted threshold ( α = 0.017). Although numerical advantages in lumbar mobility were observed in the needle-knife group, these differences did not reach the prespecified adjusted significance level after multiple testing correction. As an outcome assessor-blinded exploratory trial with unmasked participants and therapists, large-sample and multicenter clinical studies are needed to further verify the conclusions, and future trials should optimize blinding schemes to reduce reporting bias.  Clinical trial registration: https://itmctr.ccebtcm.org.cn/mgt/project/user/approved-list , identifier (ITMCTR2025002191).
SN  - 1664-2295
ER  -