• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Comparison of intradiscal targeted plus epidural collagenase injection versus coblation nucleoplasty for HIZ-positive discogenic low back pain

Corresponding author: wangyan, ch2004640029@fy.ahmu.edu.cn
DOI: 10.12201/bmr.202610.00068
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: AbstractObjective: To compare 6-month clinical outcomes of CT-guided intradiscal targeted plus epidural collagenase injection with coblation nucleoplasty in patients with MRI high-intensity zone (HIZ)-positive discogenic low back pain.Methods: A prospective randomized controlled trial was conducted. Sixty-four patients with HIZ-positive discogenic low back pain who met the inclusion criteria were randomly assigned to two groups. The collagenase group (CO group, n = 32) received CT-guided intradiscal HIZ-targeted collagenase injection (200 IU) combined with ipsilateral epidural collagenase injection (1000 IU). The control group (CN group, n = 32) underwent CT-guided percutaneous coblation nucleoplasty. Visual Analogue Scale (VAS) scores for low back and leg pain, Oswestry Disability Index (ODI), and modified MacNab criteria were assessed preoperatively and at 3 days, 1 month, 3 months, and 6 months postoperatively.Results: Baseline characteristics were comparable between the two groups. At all postoperative time points, VAS and ODI scores improved significantly compared with preoperative values in both groups (P < 0.05), with no statistically significant intergroup differences at any time point (P > 0.05). At the 6-month follow-up, the excellent-and-good rate according to the modified MacNab criteria was 87.5% in both groups (CN group: excellent in 21, good in 7, fair in 4; CO group: excellent in 22, good in 6, fair in 4), and no significant difference was found in the excellent-and-good rate between the groups (χ² = 0.000, P = 1.000). Further analysis using the Mann–Whitney U test revealed no significant difference in the overall distribution of efficacy grades between the two groups (U = 496.0, Z = ?0.316, P = 0.752). Operative time and hospitalization costs in the CO group were significantly lower than those in the CN group (P < 0.05).Conclusions: Within 6 months, pain and function improved in both groups, with no statistically significant between-group difference detected. Operative time and hospitalization costs were lower in the collagenase group. This exploratory study does not establish equivalence or noninferiority; longer follow-up and larger studies are needed.Keywords: discogenic low back pain; high-intensity zone; collagenase chemonucleolysis; target injection

    Key words: discogenic low back pain; high-intensity zone; collagenase chemonucleolysis; target injection

    Submit time: 30 October 2026

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2026-08-06

    10.12201/bmr.202610.00068V1

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刘欢, liuyujia, wangqiang, wangyan. Comparison of intradiscal targeted plus epidural collagenase injection versus coblation nucleoplasty for HIZ-positive discogenic low back pain. 2026. biomedRxiv.202610.00068

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