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The objective of this randomized, open-label, controlled clinical trial was to contrast the safety and effectiveness of the perineural and epidural routes of administering autologous conditioned serum to relieve low back pain.
Both epidural and perineural administration of autologous conditioned serum injections exhibit comparable analgesic effects when used for the management of low back pain.
The objective of this randomized, open-label, controlled clinical trial was to contrast the safety and effectiveness of the perineural and epidural routes of administering autologous conditioned serum to relieve low back pain.
A total of 100 subjects were recruited and randomly divided into two comparative groups. Volunteers in Group A (n = 50) were given the epidural (interlaminar) approach, consisting of two ultrasound-guided injections as the control intervention. Each injection contained two doses of autologous conditioned serum, with a volume of 8 mL. Volunteers in Group B (n = 50) were administered the perineural (periarticular) approach, which involved two ultrasound-guided injections as the experimental intervention at 7-day intervals, using the same volume of autologous conditioned serum.
The examinations included an initial evaluation and control evaluations at 4 (T1), 12 (T2), and 24 (T3) weeks following the last intervention. The major endpoints incorporated Roland Morris Questionnaire (RMQ), Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Euro Quality of Life—5 Dimensions–5 Levels (EQ-5D-5L): Level Sum Score (LSS), Visual Analogue Scale (VAS), and Index. Additionally, the study analyzed secondary endpoints, which involved examining differences between the groups in specific endpoints for the aforementioned questionnaires.
After analyzing the EQ-5D-5L index from baseline to 24 weeks, it was found that the epidural group showed an average improvement of 0.0969, resulting in an effect size of 0.7. On the other hand, the perineural group exhibited a higher mean improvement of 0.119, but with a slightly lower effect size of 0.62 due to a slightly greater standard deviation within that group. When comparing the two groups, there was a slight mean difference of 0.022 favoring the perineural group, with a between-group effect size of 0.13.
Analyzing the ODI between baseline and 24 weeks, the epidural group displayed a mean improvement of 7.8, yielding an effect size of 0.95. In contrast, the perineural group demonstrated a higher mean improvement of 8.78, but with a slightly lower effect size of 0.91 because of a slightly higher standard deviation in this group. The between-group comparison indicated a slight mean difference of 0.98 favoring the perineural group with a between-group effect size of 0.11.
Statistically analyzing the RMQ between baseline and 24 weeks, it was observed that the epidural group had a mean improvement of 3.55, corresponding to an effect size of 0.79. Conversely, the perineural group showed a greater mean improvement of 3.94, but with a lower effect size of 0.74 because of the higher standard deviation in this group. The between-group comparison demonstrated a slight mean difference of 0.38 favoring the perineural group, resulting in a between-group effect size of 0.08.
Throughout the 24-week study period, none of the treatment groups reported any serious adverse events. The follow-up period did not indicate any pivotal complications. In the first group, two cases of transient benign headache were reported, while in the second group, one case of dizziness was reported shortly after the injection. No instances of infections or neurological deficits were observed. Both treatment approaches were found to be well-tolerated.
Both perineural and epidural autologous conditioned serum injections had similar efficacy and demonstrated substantial enhancements in primary clinical parameters, such as disability and pain. Hence, both approaches can be considered equally efficient to combat lumbar degenerative disc disease-associated low back pain.
Brain Sciences
Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial
Piotr Godek et al.
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