Trial reportBMC musculoskeletal disorders2025
Supplemental nucleus pulposus allograft in patients with lumbar discogenic pain: results of a prospective feasibility study.
Trial report in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05201287 (A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Patients With Symptomatic Degenerated Discs), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Patients With Symptomatic Degenerated Discs
Who cites it
3 citing papers in PubMed.
- Article
- Comparing Medicare Claims in Patients with Lumbar Discogenic Pain Managed Conservatively or with Intradiscal Nucleus Pulposus Allograft.Journal of pain research · 2026Article
- A Primer on Anatomy, Biophysics, Pathology, Imaging and Treatment of the Intervertebral Disc and the Anterior Spinal Column: The Discogenic, Intervertebral, Spinal Column (DISC) ASPN Workgroup.Journal of pain research · 2025Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDegeneration of the intervertebral disc is a significant source of chronic axial low back pain. Direct supplementation of degenerated nucleus pulposis (NP) tissue with intradiscally delivered allogeneic NP represents an opportunity to bridge the treatment gap between failed conservative care and spine surgery for patients with lumbar discogenic pain.
methodsProspective, single-arm clinical study conducted at 6 sites in the US. The primary objective was to determine the magnitude of improvement in back pain severity and back function in patients with chronic lumbar discogenic pain at 12 months after a single intradiscal supplementation procedure using a commercially available NP allograft at up to two vertebral levels identified on magnetic resonance imaging. Back pain severity was evaluated using an 11-point numeric rating scale (NRS) and back function using the Oswestry Disability Index (ODI). Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) were set at ≥ 30% and ≥ 50% over baseline, respectively. The patient acceptable symptom state (PASS) threshold for pain severity was ≤ 3.
resultsTwenty-eight participants with a mean age of 44 ± 13 yrs. were enrolled and 22 provided 12-month outcomes. The average overall improvement in back pain severity was 43% through 12 months (p < 0.001). Approximately 64% (14 of 22) achieved the MCID in back pain at 12 months, with 55% (12 of 22) realizing SCB. Almost 60% (13 of 22) reported a 12-month back pain severity score of ≤ 3. The corresponding average decrease in ODI values was 50% (p < 0.001) with approximately 59% (13 of 22) of study participants achieving the MCID. At baseline approximately 82% (23 of 28) of participants reported severe or crippled back impairment compared to 18% (4 of 22) at 12 months (p < 0.001).
conclusionThe results of this study provide additional evidence that supplementation of the degenerated intervertebral disc with intradiscally delivered allogeneic NP is associated with clinically significant pain palliation and functional improvement.
trial registrationThis trial was prospectively registered at ClinicalTrials.gov on December 30, 2021 (NCT05201287).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.