Is There Clinical Improvement Associated With Intradiscal Therapies? A Comparison Across Randomized Controlled Studies

Abstract

Study design: Post hoc comparison using single-site data from 4 multicenter randomized controlled trials.

Objectives: Discogenic back pain is associated with significant morbidity and medical cost. Several terminated, unreported randomized controlled trials have studied the effect of intradiscal biologic injections. Here we report single-center outcomes from these trials to determine if there is clinical improvement associated with these intradiscal injections.

Methods: Post hoc comparison was performed using single-site data from 4 similar multi-center randomized controlled trials. All trials evaluated an injectable therapy (growth factor, fibrin sealant, or stem cells) for symptomatic lumbar disc disease with near-identical inclusion and exclusion criteria. Demographics and patient reported outcomes were analyzed across treatment arms postinjection.

Results: A total of 38 patients were treated with biologic agents and 12 were treated with control saline injections. There was a significant decrease in visual analogue score (VAS) pain for both the investigational and saline groups up to 12 months postinjection (P < .01). There was no significant difference in VAS scores between the saline and investigational groups at 12 months. Similarly, there was significant improvement in patient-reported disability scores in both the investigational and saline groups at all time points. There were no significant differences in disability score improvement between the saline and investigational treatment groups at 12 months postinjection.

Conclusions: A single-center analysis of 4 randomized controlled studies demonstrated no difference in outcomes between therapeutic intradiscal agents (growth factor, fibrin sealant, or stem cells) and control saline groups. In all groups, patient reported pain and disability scores decreased significantly. Future studies are needed to evaluate the therapeutic benefit of any intradiscal injections.

Keywords: degenerative disc disease; discogenic back pain; intradiscal therapy; saline.

Figure 1.

Single-center flow diagrams for the 4 reported randomized control studies: A, B, C, and D.

Figure 2.

Mean visual analogue scale (VAS) pain score changes (and 95% CIs) over time for the experimental therapeutic and saline placebo groups for study A, B, C, and D. Asterisk (*) denotes statistical significance between arms at certain time points. Plus (+) denotes statistical significance compared to baseline value.

Figure 3.

Mean disability score changes (and 95% CIs) over time for the experimental therapeutic and saline placebo groups for study A, B, C, and D. Asterisk (*) denotes statistical significance between arms at certain time points. Plus (+) denotes statistical significance compared to baseline value.

Figure 4.

Mean visual analogue scale (VAS) pain score changes (and 95% CIs) over time for the grouped experimental therapeutic cohort and grouped saline cohort. Asterisk (*) denotes statistical significance between arms at certain time points. Plus (+) denotes statistical significance compared with baseline value.

Figure 5.

Mean adjusted disability score changes (and 95% CIs) over time for the grouped experimental therapeutic cohort and grouped saline cohort. Asterisk (*) denotes statistical significance between arms at certain time points. Plus (+) denotes statistical significance compared with baseline value.

Figure 6.

Kaplan-Meier survival graph demonstrating survival time after injection to further interventional treatment for discogenic pain in the grouped experimental therapeutic cohort and grouped saline cohort.