Intradiskal biacuplasty can provide patients who have diskogenic low back pain with long-term improvements in pain scores and physical function, a new Canadian study suggests.
Investigators conducted a 12-month study to determine the effectiveness of intradiskal biacuplasty (IDB) combined with conventional medical management (CMM) versus CMM alone for the treatment of diskogenic low back pain (LBP), which affects 26% to 42% of chronic LBP patients (World J Orthop 2013;4:42-52). The study included 63 patients with one level of spinal disk disease. Patients were randomized to receive IDB plus CMM (n=29) or CMM alone (n=34).
“The active [treatment] group … underwent biacuplasty, which is an insertion of two cannulae into the intervertebral disk, and subsequent creation of radiofrequency field between them, that heats the intervertebral disk up to 60 to 70 degrees Celsius,” said Michael Gofeld, MD, the study’s senior author and associate professor in the Department of Anesthesia at the University of Toronto. “As a result, the nociceptive fibers that live there were ablated.”
Patients in the CMM-alone group were allowed to cross over and receive IDB six months after randomization. The main outcome measures were changes from baseline in patients’ visual analog scale (VAS) pain score, Oswestry Disability Index (ODI), 36-Item Short Form Survey (SF-36), Patient Global Impression of Change (PGIC) and Health-Related Quality of Life (EQ-5D).
Dr. Gofeld said treating physicians were allowed to use any CMM options available in the real-world setting. “We allowed [patients] to do anything and everything. So any injections, medications, physical therapy, chiropractic care, acupuncture—whatever was prescribed by the treating physician. Only spinal surgery was not allowed to happen during this period of time,” said Dr. Gofeld. “After six months were over, patients who were in the conservative management group were allowed to cross over. Interestingly enough, the majority of patients elected to cross over to the biacuplasty group.”
The researchers found that 22 patients in the original IDB plus CMM group reported significantly and clinically superior outcomes at 12 months compared with baseline. Their mean VAS and ODI scores decreased by 2.2 and 14 points, respectively. These patients also improved their PGIC score by 1.7 points (out of five) and EQ-5D score by 0.13 points. The SF-36 score improved by 15 points. Twenty-five patients in the CMM-alone group elected to cross over to IDB. These patients experienced similar results to the IDB plus CMM group at month 6, suggesting that this procedure can still benefit patients as long as they receive it during the treatment period.
“The crossover group did absolutely the same as [the] original group, which means practically those patients who continued six months of conservative management and failed, can be retrieved. They still get better if this procedure is provided, even on a delayed basis,” Dr. Gofeld said.
He noted that it was surprising to see that patients who received IDB maintained these results and even improved over time.
“Contrary to the majority of interventional pain treatments, when you see stellar results for one month, three months and then steady decline,” Dr. Gofeld said, “here we see improvement—not just pain score, but functional outcome: SF-36, ODI, patient satisfaction and quality of life as measured by EQ-5D.”
There were three serious complications reported in the original IDB plus CMM group, but they were not associated with the treatment, according to the researchers. Dr. Gofeld said the level of disk disease used was a limitation of the study: Clinicians would perform this procedure on patients with two levels in the clinical environment versus one. He noted that IDB will not solve the degenerative disk problem, but he hoped that it will help patients to improve their quality of life.
This study is a follow-up to a randomized, placebo-controlled trial that showed the clinical benefits of IDB for patients with diskogenic LBP (Pain Med2013;14:362-373). The trial included 59 patients with a history of chronic LBP for more than six months. The patients were randomized to receive IDB (n=29) or sham treatment, in which probes were not inserted into the disk space and radiofrequency energy was not used. The main outcome measures were physical function, pain, disability and opioid use. Follow-up was conducted for all patients at months 1, 3 and 6. The researchers found that the IDB group reported significant improvements in physical function, pain and disability.
Dr. Gofeld said the next step is to urge payors to approve the procedure.
“Medicare and other carriers basically stopped reimbursement for any intradiskal procedures. Surprisingly, they’re still paying for much more expensive and less effective spinal fusions,” he noted.
He hopes the findings from this efficacy study will help insurance companies to make simple cost-effectiveness analyses and approve IDB. The study had good results and the procedure is “really effective.”
“After one month, the patients would come back and say, ‘You know what? It really hurts.’ I’d say, ‘Wait. Go back to physical therapy and hang on,’” Dr. Gofeld said. “After three months, they came back and said, ‘My life is back and my back is not bad.’ Six months—even better.”
The findings were presented at the American Academy of Pain Medicine’s 2016 annual meeting (poster 123).