PALM SPRINGS, Calif. -- Biacuplasty combined with conventional treatment reduces pain and leads to improved quality of life and function in patients with discogenic back pain better than conventional treatments alone, a researcher said here.
The treatment led to a mean 2.4-point decrease in patient-reported pain scores over 6 months using a standard visual analogue scale (VAS) in a randomized, multicenter, cross-over trial -- a clinically meaningful result equating to about a 30% reduction in pain, said the lead investigator, , of the University of Toronto.
Looking at a higher response threshold, 50% reduction on the VAS scale, there were still substantial improvements in patients who underwent the therapy. At 6 months, only 7% of patients assigned to conventional treatment group had a VAS score reduction of 50% or more, compared to 42% of the group who underwent biacuplasty at the start, as well as 27% of control patients who later underwent the procedure.
Gofeld reported the results here at the .
The intradiscal biacuplasty (IDB) procedure involves thermal ablation of nerves in damaged spinal discs, with the goal of interrupting pain signalling. In particular, Gofeld described the use of internally-cooled radiofrequency ablation that utilizes two probes applied to a lumbar disc where abnormal ingrowth of nerves results in chronic low back pain.
The tips of the probe are internally cooled via a built-in circulation system. The cooled tip keeps tissue resistance low. "This allows for the radiofrequency to spread deeper into the tissue," Gofeld told 鶹ý in an interview. Two tips treat a larger volume of tissue.
A total of 293 patients were screened for the study but those with multi-level disease, prior lumbar surgery and negative discography were excluded. After exclusions, a total of 63 patients were randomized into one of two treatment groups. At baseline, all patients were evaluated for level of pain, disability, depression, quality of life, and other measures.
In the first group, 29 patients underwent conventional treatment plus IDB. They underwent follow-up at 1, 3, 6, and 12 months. In the second group, 34 patients underwent conventional treatment alone, followed in 6 months by IDB if they wished. A total of 25 patients in this group did cross over to the biacuplasty.
Standard or conventional medical treatment included modalities such as physical therapy, pharmacologic management, behaviour therapy, spinal injections, and more.
Secondary endpoints included disability and quality of life at 6 months: patients who underwent IDB (both the original IDB group and the cross-over group) showed significant improvements, according to Gofeld.
"Biacuplasty plus conventional treatment offers significant pain and is a promising treatment for this patient population," he said.
Disclosures
The study was funded by Halyard Health.
Primary Source
American Academy of Pain Medicine
Gofeld M, et al "Long-term results (12-months) of a prospective, multi-center, open-label clinical trial comparing intradiscal biacuplasty (IDB) to conventional medical management (CMM) for discogenic lumbar back pain (LBP)" AAPM 2016; Poster 123.