More Doubts Surfacing About Spinal Cord Stimulators for Injured Workers
Monday, January 22, 2018 | 0
Competition is heating up among makers of spinal cord stimulators, as the devices, which are touted as an alternative to opioids for treating chronic pain, are becoming smaller and more sophisticated.
At the same time, workers’ comp systems in some states are limiting use of the devices due to doubts about their effectiveness.
Spinal cord stimulators are surgically implanted devices that send electrical signals along the spinal cord, which may alleviate pain for some patients by disrupting nerve signals. The technology is generally used to treat pain in the back or lower extremities.
According to the American Chronic Pain Association, conditions that may respond favorably to SCS include failed back surgery syndrome with radicular symptoms, complex regional pain syndrome and peripheral neuropathic pain.
According to Medtronic, a company that makes the devices, SCS can provide relief when treatments such as drugs or injections have failed. Patients can try out the device before it’s permanently implanted to assess their level of pain relief. And even after it’s implanted, the device can be removed if the patient no longer wants the treatment, Medtronic said.
Medtronic last year launched a new spinal cord stimulator in the U.S. called Intellis, which is about 40% smaller than the company’s previous device and recharges more quickly.
The company is hoping to regain market share with Intellis along with a new platform called Evolve that’s aimed at simplifying programming of the stimulator.
Spinal cord stimulators make up about half of Medtronic’s pain therapies sales, and “lack of a competitive system has impeded growth for the past few quarters,” analysts from RBC Capital Markets said following a presentation from the company this month.
Nevro Corp. this month announced it had received Food and Drug Administration approval for its Senza II device, a spinal cord stimulator that is more compact than its predecessor. Nevro Corp. has said that its Senza system, which uses high-frequency impulses, eases pain without paresthesia, a tingling or buzzing sensation that’s experienced with other types of stimulators. The FDA approved the Senza system in May 2015.
In marketing the Senza system, Nevro has characterized the device as an alternative to opioid treatment.
“Superior, non-opioid therapy now delivered in a smaller and more refined IPG (implantable pulse generator),” the company said in a heading for its news release announcing the FDA approval.
Dr. Steven Moskowitz, senior medical director of Paradigm Outcomes, said spinal cord stimulator companies have been promising for years that the devices would get patients off opioids while improving their function — a promise that for the most part hasn’t been kept. Paradigm provides medical management for catastrophically injured workers.
“Though some are trying to brand spinal cord stimulators as ‘non-opioid’ treatment, they are not a specific treatment for opioid dependence or addiction,” Moskowitz said by email on Friday. “Such rebranding does not in itself make spinal cord stimulators more effective or more indicated than they have been.”
Many studies of spinal cord stimulator effectiveness have measured the patient’s change in pain rating and their opinion on whether they would choose the device again, Moscowitz said. But in workers’ comp, the important outcomes are improved function and health, he said.
“Functional outcomes should include pain rating, but also must include major functional improvement, return to work and decreased need for health care utilization for pain (i.e. decreased meds, doctor visits, invasive procedures)," he said.
Spinal cord stimulators have shown relatively unimpressive outcomes for injured workers, Moskowitz said, prompting some states to limit coverage of the devices.
In a 2010 health care technology review, the Washington State Health Care Authority's Health Technology Clinical Committee determined that "SCS is less safe than alternatives, is an invasive procedure and has many adverse events.”
As a result, spinal cord stimulation for chronic neuropathic pain is not a covered benefit for Washington state health care agencies, including its workers’ comp system. Following a new search of the medical literature in 2013, the committee determined there wasn’t enough evidence to change its coverage decision.
The California Division of Workers’ Compensation last year decided to move forward with adoption of treatment guidelines from the American College of Occupational and Environmental Medicine, which for the most part don’t recommend spinal cord stimulators. The ACOEM chapter on chronic pain recommends spinal cord stimulators for short- to immediate-term relief of complex regional pain syndrome for carefully selected patients.
In Oregon, the Workers’ Compensation Division’s Medical Advisory Committee has been evaluating whether spinal cord stimulators should be a compensable treatment for injured workers. During a meeting last month, the committee seemed to be leaning toward maintaining the device’s status as a compensable treatment.
The panel is expected to reach a final decision at its next meeting, on Feb. 16. MAC is an advisory body to the Workers’ Compensation Division.
Oregon’s state-chartered workers’ compensation carrier, SAIF Corp., provided the committee with an analysis of its own claims that included the implantation of a spinal cord stimulator between January 2010 and April 2017.
Out of 75 workers receiving spinal cord stimulators during that time, one was released from modified work to regular work at one year post-surgery; for the remainder, there were no changes in work status after one year, SAIF said.
The percentage of injured workers who were using opioids before receiving the spinal cord stimulator was about 71%, according to the analysis. From 180 to 365 days post-surgery, that number dropped to 55%.
Forty-six percent of the spinal cord stimulator surgeries resulted in a revision to the equipment just over one year later, SAIF said.
“The spinal cord stimulator is considered a permanent device to reduce the injured worker’s pain and decrease the utilization of pain medications,” SAIF senior research analyst Bryan Null wrote to the committee. “We are not seeing significant positive impact in either of these areas.”
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