NATIONAL HARBOR, MD — Intradiscal biacuplasty (IDB), a minimally invasive treatment for discogenic low back pain, provides reductions in pain and improvements in function superior to those seen with traditional measures of conventional therapy, according to a new study.
“[While] intradiscal biacuplasty now has a robust body of literature supporting its use, this study adds to the existing data by further elucidating ideal candidates for the procedure, positioning its use in patients and strengthening the data by demonstrating its superiority over conservative medical management,” lead author Mehul J. Desai, MD, MPH, from George Washington University Hospital, Washington, DC, told Medscape Medical News.
With options for discogenic low back pain traditionally limited to invasive surgical procedures or conventional management approaches, IDB offers a unique approach of cooled radiofrequency (RF). The RF is applied, using fluoroscopy, introducer needles, and RF probes, to areas of pain, targeting nociceptive nerves in degenerative spinal discs for ablation.
The first trial to compare the treatment with conservative management approaches was presented here at the American Academy of Pain Medicine (AAPM) 31st Annual Meeting.
Chronic Discogenic Back Pain
For the study, Dr Desai and colleagues randomly assigned 63 patients with a history of chronic discogenic low back pain that was unresponsive to nonoperative care to treatment with one IDB procedure and conservative management (n = 29) or to conservative management alone (n = 34).
Conservative management consisted of such measures as physical therapy, medication management, behavioral therapy, weight loss, acupuncture, and/or common interventions (eg, lumbar-epidural injections or sacro-iliac joint injections).
All patients had an average daily reported pain greater than 5 out of 10 on the visual analogue scale (VAS) at baseline.
The results at the 6-month follow-up showed substantially higher rates in the IDB group for the primary outcome of treatment response, defined as a 2-point or 30% decrease in VAS scores, compared with the conventional management group (50% vs 18%).
The mean change in VAS score in the IDB group was –2.4, compared with just –0.56 in the conventional management group (P = .02). The IDB group also showed consistently greater improvement in measures including the SF-36-physical functioning, Oswestry Disability Index, and patients’ global impression of change scores.
After the 6-month follow-up period, patients in the conventional therapy group had the option of crossing over to the IDB group.
Dr Desai noted that candidates who appear best suited for IDB include those who still have relatively healthy discs and who are motivated to improve their pain. While obesity does not exclude patients from the procedure, it may result in a more challenging recovery process, he said.
“Patients with obesity are often placing greater pressure on their discs, and this might result in less optimal recovery.”
“Patients who demonstrate motivation to be fit and loss weight responsibly may still benefit from the procedure,” Dr Desai added.
Important Evidence
James C. Watson, MD, a pain specialist and neurologist with the Mayo Clinic, Rochester, Minnesota, said the study offers important evidence underscoring the extent of the potential benefits patients can receive from IDB.
“We have no good treatments for discogenic axial low back pain,” he told Medscape Medical News. “Biacuplasty has been previously well described as a treatment, but evidence was not sufficient for broad insurance coverage of this treatment,” he noted.
“This is a well-designed prospective, randomized trial with 6-month data comparing intradiscal biacuplasty with conservative therapy (and) it provides the best evidence yet for an effective treatment for discogenic axial low back pain,” Dr Watson said.
The study was funded by Halyard Health. Dr Desai and Dr Watson have disclosed no relevant financial relationships.
American Academy of Pain Medicine (AAPM) 31st Annual Meeting. Abstract LB003. Presented March 20, 2015.