Intradiscal Nucleus Pulposus Allograft Versus Sham Procedure in Patients with Lumbar Discogenic Pain: A Randomized Clinical Trial
5 affiliations
- 1Metro Pain Group, Monash House, 271 Clayton Road, Clayton, VIC 3168, Australia
- 2Sydney Pain Day Surgery, Suite 3/44-46 Oxford St., Epping, NSW 2121, Australia
- 3Advanced Spine & Pain, Prince of Wales Private Hospital, Level 7, Suite 24/346 Barker St., Randwick, NSW 2031, Australia
- 4PainMedSA, 5 Greenhill Rd, Wayville, SA 5034, Australia
- 5Hunter Pain Specialists, 91 Chatham St., Broadmeadow, NSW 2292, Australia
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.
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BibTeX
@article{verrills2026intradiscal,
title = {{Intradiscal Nucleus Pulposus Allograft Versus Sham Procedure in Patients with Lumbar Discogenic Pain: A Randomized Clinical Trial}},
author = {Paul Verrills and Vahid Mohabbati and James Yu and Matthew Green and Daniel Bates and Harrison Mihailidis and Marc A. Russo},
journal = {Journal of Clinical Medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15218389},
url = {https://www.mdpi.com/2077-0383/15/21/8389},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Intradiscal Nucleus Pulposus Allograft Versus Sham Procedure in Patients with Lumbar Discogenic Pain: A Randomized Clinical Trial
AU - Paul Verrills
AU - Vahid Mohabbati
AU - James Yu
AU - Matthew Green
AU - Daniel Bates
AU - Harrison Mihailidis
AU - Marc A. Russo
PY - 2026
DA - 2026/10/28
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218389
UR - https://www.mdpi.com/2077-0383/15/21/8389
AB - 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.
SN - 2077-0383
ER -