by Elizabeth Hofheinz, M.P.H., M.Ed.
With an estimated 16 million adults—8% of all adults—experiencing chronic back pain1, there is a dire need to make headway in methods of treating this scourge.
When researchers from the Indiana Spine Group in Carmel, Indiana teamed up with those from the University of Texas—Dell Medical School, and the Ascension Texas Spine and Scoliosis Center in Austin, Texas, they considered recent studies that have highlighted the potential contribution of vertebrogenic sources of chronic low back pain (CLBP).
A co-author on the study was spine surgeon Eric Truumees, M.D. of the Ascension Texas Spine and Scoliosis Center. Dr. Truumees told OSN, “While most people with low back pain get better on their own or with traditional, non-operative management, it is a common enough problem that there are huge numbers of people with chronic low back pain that markedly interferes with their function and quality of life. For these patients, larger, fusion surgeries or arthroplasty are options, but they have significant limitations, too. I was interested in a ‘medium hammer’—a more efficacious treatment for chronic low back pain that did not require segmental fusion or implant placement.”
The researchers set out on a prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with basivertebral nerve ablation. Patients were followed postoperatively for 12 months using Oswestry Disability Index (ODI) and Visual Analogue Score (VAS), EuroQol (EQ-5D-5L) and Short Form-36 (SF-36) patient reported outcome metrics.
The result? A total of 47 patients received basivertebral nerve ablation, with 45 completing 12 months of follow up. At 12 months, the mean reduction in ODI was 32.31 +/- 14.07 with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15.
“This study sought to confirm the effectiveness of the Intracept procedure that had been demonstrated in randomized trials in a more permissive, typical clinical environment,” said Dr. Truumees to OSN. “It found that 75.56% of the patients studied achieved a good clinical response. In this case that meant a combined threshold of ≥ 20- point ODI and ≥ 2-point VAS improvement.”
When asked what further work he would like to do on this subject, Dr. Truumees told OSN, “A 75% response is pretty good for a low back pain study. But, I’d like to understand the differences between the responders and the 25% that did not get a great response. Other studies have shown good durability of the treatment effect to 5 years, but this needs to be carried further into future. Additionally, it would be interesting to see whether symptoms improve in those non-responders that end up getting fusion or arthroplasty surgery.”
“These later, small clinical studies are confirming the results of the initial randomized trials. If, as the procedure utilization grows, these results continue to be seen, basiverterbal nerve ablation may become a major treatment modality for chronic, vertebrogenic low back pain. While this is only one form of low back pain, the potential beneficial impacts in terms of pain and function are enormous.”