{
  "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.\n\nObjective: 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.\n\nMethods: 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.\n\nResults: 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.\n\nConclusion: 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.\n\nClinical trial registration: https://itmctr.ccebtcm.org.cn/mgt/project/user/approved-list , identifier (ITMCTR2025002191).",
  "abstract_shown": true,
  "affiliations": [
    "College of Acupuncture and Massage, Henan University of Chinese Medicine",
    "The Third Affiliated Hospital of Henan University of Chinese Medicine"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Yiming Zhang"
    },
    {
      "affs": [
        0
      ],
      "name": "Ruiguo Li"
    },
    {
      "affs": [
        0
      ],
      "name": "Xiaohong Zhang"
    },
    {
      "affs": [
        0
      ],
      "name": "Zhanyou Wang"
    },
    {
      "affs": [
        1
      ],
      "name": "Ziwei Zhang"
    },
    {
      "affs": [
        1
      ],
      "name": "Huanhuan Xu"
    },
    {
      "affs": [
        1
      ],
      "name": "Xiaofan Li"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/eqspeeebskvdc.bib",
  "cited_by": 0,
  "doi": "10.3389/fneur.2026.1898714",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13719306/?tool=EBI",
  "id": "eqspeeebskvdc",
  "issns": [
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  "landing_url": "https://www.frontiersin.org/articles/10.3389/fneur.2026.1898714/full",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Clinical Trial"
    ],
    [
      "openalex",
      "2734|Spine and Intervertebral Disc Pathology"
    ]
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  "openalex": "W7222527256",
  "pdf_url": "https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2026.1898714/pdf",
  "pmcid": "PMC13719306",
  "pmid": "42964068",
  "published": "2026-10-16",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/eqspeeebskvdc.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:16Z",
      "native_id": "10.3389/fneur.2026.1898714",
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      "url": "https://www.frontiersin.org/articles/10.3389/fneur.2026.1898714/full"
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      "first_seen": "2026-10-31T12:21:37Z",
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  "subjects": [
    {
      "field": "medicine",
      "origin": "issn:1664-2295",
      "subfield": "neurology"
    }
  ],
  "title": "Needle-knife lumbosacral therapy for lumbar disc herniation: a single-center, outcome assessor-blinded randomized controlled trial",
  "title_text": "Needle-knife lumbosacral therapy for lumbar disc herniation: a single-center, outcome assessor-blinded randomized controlled trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-03T12:20:23Z",
  "url": "https://research.draconitic.com/paper/eqspeeebskvdc",
  "venue": "Frontiers in Neurology",
  "versions": []
}