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.

Consolidating and re‐evaluating the human disc nutrient microenvironment

“… 9 , 11 , 57 , 58 In total, 16 clinical trials investigating cell‐based therapies have been registered worldwide for IVD degeneration and although they demonstrate the procedures to be safe, clinical evidence of positive efficacy remains unclear. 8 , 54 , 55 , 59 , 60 To fully realize these strategies and maximize clinical translation of cell‐based therapies, there is an urgent need to consolidate what is already known regarding the in vivo nutrient microenvironment.…”

The contributions of cartilage endplate composition and vertebral bone marrow fat to intervertebral disc degeneration in patients with chronic low back pain

“…While intervertebral disc degeneration is prevalent in people without chronic low back pain (cLBP), there is a strong implication that disc degeneration causes cLBP in certain subgroups [ 1 ] and consequently, therapeutically slowing or reversing disc degeneration is a common but as yet unrealized clinical goal. Cell-based biologic therapies to regenerate the disc have demonstrated mixed efficacy in clinical trials, and a key obstacle to successful translation of these therapies is an incomplete understanding of the mechanisms of cellular homeostasis and the factors disrupting homeostasis in degenerating discs [ 2 , 3 ]. One specific knowledge gap is the uncertain role of cartilage endplate (CEP) composition relative to vertebral vascularity.…”

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

“… Level I-C Navani et al, 2018 450 [PRP or MSCs] Prospective case series 20 NRS, SF-36 This study supports the safety of a single intradiscal biologic injection and provides addition evidence for the efficacy in management of lumbar discogenic pain, with improvements in both pain and function, and decreased utilization of medications and medical services thereby decreasing health care costs. Level I-C Ju et al, 2020 83 [growth factor, fibrin sealant, or stem cells] Post hoc comparison using single-site data from 4 multicenter RCTs. 50 VAS and disability scores.…”

“…The authors suggested that perhaps saline injection itself has a therapeutic effect, possibly by diluting pro-inflammatory mediators within the degenerated disk, decreasing intradiscal pressure, or a combination of the placebo effect. The small sample sizes and heterogeneity of combining multiple studies make it difficult to draw conclusions from this study 83 (see Table 9 for evidence summary).…”