Trial reportPain medicine (Malden, Mass.)2026
The safety and effectiveness of lumbar transforaminal injection of sterile amniotic fluid filtrate compared to steroid for lumbosacral radicular pain due to spinal stenosis: a phase I/II double-blinded randomized trial.
Trial report in Pain medicine (Malden, Mass.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04537026 (A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis: Improving Safety and Outcomes in the Treatment of Pain and Disability Related to Spinal Stenosis.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
backgroundRadicular symptoms from lumbosacral spinal stenosis (LSS) are commonly managed with conservative measures, including transforaminal epidural steroid injection (TFESI). However, repeated use may cause systemic side effects in some patients. Human amniotic fluid filtrate (hAF), containing anti-inflammatory, neuroprotective, and regenerative factors, has shown therapeutic potential in pre-clinical models and other medical conditions.
objectivesCompare the safety and effectiveness of transforaminal epidural injections with hAF versus dexamethasone for treating radicular pain from LSS.
designDouble-blinded, prospective, randomized comparative trial.
methodsFifty-eight participants were included, with outcomes assessed at 3 weeks, 6 weeks, 3 months (primary endpoint), and 6 months. Primary outcomes were adverse events (AEs) and proportions of participants reporting ≥50% numerical pain rating scale (NPRS) back and leg pain reductions at 3 months. Secondary outcomes included Oswestry Disability Index (ODI), Swiss Spinal Stenosis Questionnaire (SSSQ), and PROMIS Physical Health Summary (PHS). Linear mixed-effects models evaluated between-group differences while accounting for repeated measures.
resultsAt 3 months, a significantly greater proportion of participants receiving dexamethasone achieved ≥50% reductions in back pain (45.8% [95%CI = 27.9%-64.9%] vs. 15.0% [95%CI = 5.2%-36.0%]; P = .050) and leg pain (60.0% [95%CI = 40.7%-76.6%] vs. 25.0% [95%CI = 11.2%-46.9%]; P = .034) compared with hAF. Secondary outcome trends similarly favored dexamethasone at 3 months. Mixed-effects models showed greater improvements to 6-week pain and function scores with dexamethasone relative to hAF. Group AE rates were comparable, and no serious intervention-related AEs occurred.
conclusionDexamethasone demonstrated significantly greater short- and intermediate-term benefits over hAF across multiple clinical outcome domains for radicular pain due to LSS, prompting early trial discontinuation.
trial registrationClinicalTrials.gov (NCT04537026); September 3, 2020.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.