{
  "abstract": "Background/Objectives: Chronic lumbar discogenic pain is a leading cause of disability. We evaluated the efficacy and safety of a single intradiscal injection of nucleus pulposus allograft compared with a sham procedure. Methods: Randomized, double-blind, sham-controlled superiority trial at five Australian pain centers. Adults with chronic lumbar discogenic pain were assigned 1:1 to allograft or sham. The prespecified primary endpoint was the proportion of participants with a ≥30% reduction in back pain visual analog scale (VAS) at 6 months. Sham non-responders could cross over to allograft treatment at 3 months; their 3-month values were carried forward to 6 months (last observation carried forward, LOCF). Results: A total of 121 participants were randomized (allograft 60, sham 61). At 3 months, the last visit at which both groups were fully observed, 53% (32/60) of allograft and 5% (3/60) of sham participants achieved the back pain responder threshold (difference 48 percentage points, 95% CI 33 to 61; p < 0.001). At 6 months, with LOCF for the 55 of 61 sham participants who crossed over, responder rates were 60% (36/60) versus 1.6% (1/61) (difference 58 percentage points, 95% CI 44 to 70; p < 0.001); superiority persisted in sensitivity analyses unless ≥45% of crossover participants would have responded untreated. Oswestry Disability Index responder rates were 53% versus 32% at 3 months and 60% versus 31% at 6 months (LOCF). Within 3 months, procedure- or product-related adverse events occurred in 6/60 (10%) allograft and 3/61 (5%) sham participants; two of these events were serious. Conclusions: Nucleus pulposus allograft produced large, clinically meaningful reductions in discogenic back pain compared with sham in the fully observed 3-month comparison. Most sham participants crossed over at three months as permitted by the protocol, and their three-month values were carried forward to the 6-month primary endpoint analysis. Registration: NCT06615505.",
  "abstract_shown": true,
  "affiliations": [
    "Metro Pain Group, Monash House, 271 Clayton Road, Clayton, VIC 3168, Australia",
    "Sydney Pain Day Surgery, Suite 3/44-46 Oxford St., Epping, NSW 2121, Australia",
    "Advanced Spine & Pain, Prince of Wales Private Hospital, Level 7, Suite 24/346 Barker St., Randwick, NSW 2031, Australia",
    "PainMedSA, 5 Greenhill Rd, Wayville, SA 5034, Australia",
    "Hunter Pain Specialists, 91 Chatham St., Broadmeadow, NSW 2292, Australia"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Paul Verrills"
    },
    {
      "affs": [
        1
      ],
      "name": "Vahid Mohabbati",
      "orcid": "0009-0005-6198-3930"
    },
    {
      "affs": [
        2
      ],
      "name": "James Yu"
    },
    {
      "affs": [
        3
      ],
      "name": "Matthew Green"
    },
    {
      "affs": [
        0
      ],
      "name": "Daniel Bates"
    },
    {
      "affs": [
        0
      ],
      "name": "Harrison Mihailidis"
    },
    {
      "affs": [
        4
      ],
      "name": "Marc A. Russo"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/6w332cha1zb3b.bib",
  "cited_by": 0,
  "doi": "10.3390/jcm15218389",
  "fulltext_url": null,
  "id": "6w332cha1zb3b",
  "issns": [
    "2077-0383"
  ],
  "landing_url": "https://www.mdpi.com/2077-0383/15/21/8389",
  "language": null,
  "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": [
    [
      "openalex",
      "2734|Spine and Intervertebral Disc Pathology"
    ]
  ],
  "openalex": "W7224128089",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-28",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/6w332cha1zb3b.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:01Z",
      "native_id": "10.3390/jcm15218389",
      "source": "crossref",
      "url": "https://www.mdpi.com/2077-0383/15/21/8389"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2734|Spine and Intervertebral Disc Pathology",
      "subfield": "general"
    }
  ],
  "title": "Intradiscal Nucleus Pulposus Allograft Versus Sham Procedure in Patients with Lumbar Discogenic Pain: A Randomized Clinical Trial",
  "title_text": "Intradiscal Nucleus Pulposus Allograft Versus Sham Procedure in Patients with Lumbar Discogenic Pain: A Randomized Clinical Trial",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:01Z",
  "url": "https://research.draconitic.com/paper/6w332cha1zb3b",
  "venue": "Journal of Clinical Medicine",
  "versions": []
}