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

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.

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.

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.

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.

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.

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