Table 1.
Clinical trials of different therapeutic modalities for low back and radicular pain
| Drug | Study design | Outcome |
|---|---|---|
| Etanercept (TNF-α decoy receptor) | Multicenter, double-blind, RCT for treating symptomatic lumbar disc herniation | Two transforaminal injections of etanercept resulted in clinically and statistically significant reduction in worst back pain and mean daily worst leg pain at 4 weeks post-treatment (Freeman et al., 2013) |
| Prospective, randomized trial for treating radicular pain in patients with lumbar spinal stenosis | Epidural injection of etanercept was more effective than dexamethasone for improving low back pain, leg pain, and leg numbness (Ohtori et al., 2012) | |
| Multicenter, 3-group, RCT for treating pain due to lumbosacral radiculopathy | No improvement when compared to placebo, and had worse efficacy than epidural steroid injection in improving pain and functionality (Cohen et al., 2012) | |
| Triple-blind RCT for treating acute sciatica secondary to lumbar disc herniation | The ODI and VAS improved at 6 weeks and at a 3- month follow-up (Okoro et al., 2010) | |
| Double-blind, controlled study for treating patients with subacute lumbosacral radiculopathy | Significant improvements in leg and back pain at 6 months (Cohen et al., 2009) | |
| Open cohort, historical group controlled study for treating patients with severe sciatica | Improvement of leg pain, low back pain at 6 weeks, as well as Roland Morris disability questionnaire and the ODI (Genevay et al., 2004) | |
| Adalimumab (Anti-TNF-α antibody) | Multicenter, double-blind, RCT for treating acute and severe sciatica and imaging-confirmed lumbar disc herniation | Small but significant improvement in sciatica, and fewer surgical procedures in short term, and markedly reduced back surgery in a 3-year follow-up (Genevay et al., 2010; Genevay et al., 2012) |
| Infliximab (Anti-TNF-α antibody) | RCT for treating patients with acute/subacute sciatica due to herniated disc | No difference compared to placebo group in improving pain at 1 year, but shortened symptom duration and less straight leg raising restriction in cases of L4- L5/L3-L4 herniation with Modic change (Korhonen et al., 2006) |
| IL-1Ra-enriched Authologous Conditioned Serum (ACS; Orthokine) | Prospective, double-blind, reference-controlled, single center, investigator-initiated study for treatment of lumbar back pain | Significant clinical improvements and VAS score, and reduction in pain and disability, ACS showed statistically significant superiority over triamcinolone at week 22 (Becker et al., 2007) |
| Bioclavid (Amoxicillin-clavulanate) | Double-blind, RCT for treatment of chronic low back pain and Modic type 1 changes Pilot prospective uncontrolled study for treating patients with low back pain and Modic type 1 changes | Statistically significant improvement on lumbar pain, leg pain, and disease-specific disability in antibiotic- treated group at 1 year (Albert et al., 2013) Clinically and statistically significant improvement in low back pain intensity, number of days with pain, disease-specific and patient-specific function, and global perceived effect at long-term follow up (mean 10.8 months) (Albert et al., 2008) |
Abbreviations: RCT, randomized controlled trial; VAS, visual analog scale; ODI, Oswestry disability index