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. 2025 Nov 1;14(21):7771.
doi: 10.3390/jcm14217771.

Efficacy of Autologous Conditioned Serum on the Dorsal Root Ganglion in Patients with Chronic Radicular Pain: Prospective Randomized Placebo-Controlled Double Blind Clinical Trial (RADISAC Trial)

Marta Homs  1   2 , Raimon Milà  3 , Jordi Recasens  1 , Diego Delgado  4 , Rosa Maria Borràs  1 , Ricard Valdés  1 , David Parés  2   5
Affiliations

Efficacy of Autologous Conditioned Serum on the Dorsal Root Ganglion in Patients with Chronic Radicular Pain: Prospective Randomized Placebo-Controlled Double Blind Clinical Trial (RADISAC Trial)

Marta Homs et al. J Clin Med. .

Abstract

Background: Pulsed radiofrequency (PRF) applied to the dorsal root ganglion (DRG) has been proposed as an effective neuromodulator treatment for persistent radicular pain. Autologous conditioned serum (ACS) therapy, derived from the patient's own blood, offers a conservative approach. This study aims to evaluate the efficacy of ACS applied to the DRG as an adjunct in treating lower limb radicular pain (LLRP). Methods: A prospective, randomized, double-blind, placebo-controlled clinical trial was conducted comparing PRF combined with ACS versus PRF with physiological saline (PhS) on the DRG. Seventy patients (35 per group) with radicular pain lasting ≥6 months and refractory to previous treatments were enrolled. The primary outcome measure was the Numeric Pain Rating Scale (NPRS); secondary measures included the Oswestry Disability Index (ODI), Mood Assessment Scale (MOAS), SF-12 quality of life questionnaire, and DN4 neuropathic pain scale. Assessments occurred at baseline, 1 month, 3 months, 6 months, and 12 months post-intervention. Results: A total of 70 patients were included. The ACS group showed a significant reduction in pain compared to controls at 30 days (p < 0.05). Additionally, neuropathic symptoms such as tingling, numbness, stubbing, and burning decreased significantly in the ACS group during this period (p < 0.05). While both groups experienced pain reduction over time, no significant differences persisted at 6 months. No adverse effects were reported. Conclusions: The addition of ACS to PRF provides a short-term, statistically significant reduction in radicular pain at 30 days, suggesting it is a safe and effective adjunct therapy for lower limb radicular pain.

Keywords: autologous conditioned serum; dorsal root ganglion; lower limb radicular pain; lumbar radicular pain; pulsed radiofrequency.

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Conflict of interest statement

The authors declare that there are no conflicts of interest related to this study. The authors confirm that this is an original work that has not been previously published and is under no consideration for publication elsewhere.

Figures

Figure 1
Figure 1
The patient flow diagram of the study. PRF: Pulsed radiofrequency; ACS: Autologous conditioned serum.
Figure 2
Figure 2
Fluoroscopic image of the procedure. The arrow in the image depicts the localization of the dorsal root ganglion (DRG) within the foramen, outlined by ionic contrast. The L4, L5, and S1 vertebrae are anatomically marked according to the fluoroscopy image.
Figure 3
Figure 3
The graph demonstrates a reduction in pain in both groups, with statistical significance observed during the initial period.
Figure 4
Figure 4
Graphic of both groups of DN4 symptoms at 30 days: Tingle, Pricks, Numbness, Sting, Hypoesthesia to touch.
See this image and copyright information in PMC

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