Efficacy of Epidural Perineural Injections With Autologous Conditioned Serum for Lumbar Radicular Compression: An Investigator-Initiated, Prospective, Double-Blind, Reference-Controlled Study

Cordelia Becker, MD; Stefan Heidersdorf, MD; Sascha Drewlo, MSc; Sonja Zirke de Rodriguez; Juergen Krämer, MD; Roland Ernst Willburger, MD

Disclosures

Spine. 2007;32(17):1803-1808. 

In This Article

Results

Study Subjects

A total of 84 patients, 52 men and 32 women, were evaluated. Of these, 83 patients had complete time courses for VAS and ODI. One patient, in the 10-mg triamcinolone group, provided no VAS or ODI data for time point 6.

The mean age was 53.9 years, ranging from 29 to 81 years. At baseline, there was no statistically significant difference between the groups with respect to age, sex, duration of symptoms, and causes of compression signs (e.g., herniated disc, protrusion, spinal stenosis, scars). The use of ibuprofen did not differ between groups.

Thirty-two patients were treated by epidural perineural injections of ACS, 27 were injected with 5 mg triamcinolone, and 25 received 10 mg triamcinolone.

Results for the Primary Study Endpoint

The pain intensity scores and the time curves for VAS are shown in Figure 1; mean, SD, and median values are given.

Figure 1.

Results for the primary study endpoint. The pain intensity scores and the time curves for VAS are shown. Mean, SD, and median are given. *Significant difference from baseline. Time schedule is given in weeks after the first injection.

The 3 treatment groups were found to be comparable with regard to VAS at baseline (P = 0.44) showing mean values of 78, 82, and 85 for ACS, triamcinolone 5 mg, and triamcinolone 10 mg, respectively (analysis of variance). Pain intensity was high initially but began to decline even after the first injection, irrespective of treatment. A further decrease in pain was observed in all groups up to Week 4 after the third injection (Week 6 after the first injection).

All comparisons within each treatment group were found to be statistically significant (P < 0.001 in all cases) in the framework of ordered testing (i.e., from time point 6 down to time point 2). VAS already showed a statistically significant reduction in all treatment groups from time point 1 to 2. VAS at time points 4, 5, and 6 appeared similar in the 2 triamcinolone groups. A further reduction of VAS from time point 4 to 5 was only observed in the ACS group (P = 0.002).

There was no significant difference between the 3 groups at the beginning of treatment, but at the end of the observation period.

The most pronounced pairwise difference was found between ACS and triamcinolone 5 mg (mean, -13.5 in favor of ACS, P = 0.06) ( Table 2 ). It is to be noted that the mean value for VAS in the ACS group (23.3) markedly differed from the median (12.5), indicating a skewed data distribution. Thus, application of the nonparametric Kruskal-Wallis test was considered as more appropriate. At nominal significance level (α = 5%; 2-sided), the ACS group was found statistically significantly different from triamcinolone 5 mg with regard to VAS at the end of the study (P = 0.046).

Secondary Study Endpoint

The ODI results are shown in Table 3 ; mean, SD, and median values are given.

The 3 treatment groups were found to be comparable with regard to baseline values (P = 0.54) showing mean values of 22, 21, and 19 for ACS, triamcinolone 5 mg and triamcinolone 10 mg, respectively (analysis of variance). The ODI improved considerably following treatment. All comparisons within each treatment group were found to be statistically significant (P < 0.001 in all cases) in the framework of ordered testing (i.e., from time point 6 down to time point 4). This means that the ODI was already statistically significantly reduced in all treatment groups at time point 4, i.e., the first measurement after time point 1. ODI at time points 4, 5, and 6 appeared similar in the 2 triamcinolone groups. A further reduction of ODI from time point 4 to 5 was only observed in the ACS group (P = 0.03). At time point 6, the ODI was similar in all treatment groups. The difference between the 3 groups was not statistically significant (P = 0.95 for score at end, P = 0.74 for the reduction).

All 3 treatments were well tolerated. There were no serious adverse events. Three patients, 1 from each group, complained about severe headache after the injection. This adverse effect was attributed to the injection procedure.

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