Woman With Back Pain And Ache. Bad Posture
Spinal cord stimulators, surgically implanted electrical devices, are increasingly used to treat chronic back pain. Designed to deliver electrical impulses to the spinal cord, these devices aim to alter the way the brain perceives pain. However, recent research raises questions about their efficacy and safety, prompting a closer examination of their use and alternatives.
Do Spinal Cord Stimulators Work?
The primary goal of spinal cord stimulators is to alleviate chronic back pain, particularly when other treatments have failed. They also aim to reduce dependency on opioids, which are known to be both ineffective and harmful for low-back pain. Yet, a 2023 Cochrane review of 13 randomized controlled trials found no significant benefits of spinal cord stimulation in the short and medium term. Only one trial extended to six months, and it also reported no benefits.
Earlier reviews, including one focused on chronic pain in general, have similarly struggled to confirm the benefits of spinal cord stimulators due to the quality and reliability of existing trials. This raises an essential question for patients and healthcare providers: Are these devices worth the investment and potential risks?
Potential Risks and Side Effects
While the promise of pain relief is enticing, the risks associated with spinal cord stimulators cannot be ignored. An analysis of 520 adverse events reported to Australia’s Therapeutic Goods Administration (TGA) revealed that 79% were severe, with 13% deemed life-threatening. Furthermore, 80% of these events required corrective surgery.
Data from private health insurers, covering 90% of spinal cord stimulator implants in Australia, showed that about one-quarter of patients needed additional surgery within a median of 17 months. These surgeries were often due to device malfunction, increased pain, infections, or complications such as punctures of the spinal cord’s protective tissues.
“Our latest findings likely underestimate the risk of these devices,” note researchers, highlighting the need for caution.
Financial Implications
The financial burden of spinal cord stimulators is significant. The cost per patient, including the device, insertion, and any subsequent surgeries, is approximately A$55,000. Even a temporary “trial” implantation costs around A$14,000. These figures exclude any out-of-pocket expenses, making it a costly option for many.
Regulatory Concerns and Guidance
In 2022, the TGA initiated a review of spinal cord stimulators due to safety and performance concerns. As a result, several devices were removed from the market, while others were subjected to stringent conditions, including mandatory safety data reporting by manufacturers.
Patients considering spinal cord stimulators are advised to conduct thorough research, focusing on independent sources such as government agencies and universities. The Cochrane Library is also recommended for reliable health information.
Questions to Discuss with Your Doctor
- Do I really need this medical implant?
- What are the risks and benefits?
- Is the medical implant approved?
- Where can I get more information?
- What happens if I experience an adverse event?
Exploring Alternative Treatments
For those seeking alternatives, several options offer effective pain management with fewer risks. Education on self-management, exercise, cognitive behavioral therapy, and non-steroidal anti-inflammatory drugs like ibuprofen have solid evidence supporting their use. Emerging therapies such as sensorimotor retraining and cognitive functional therapy also show promise.
Spinal cord stimulation illustrates a treatment that may have outpaced the evidence. Although introduced in the 1960s, reliable trials assessing their efficacy have only emerged recently. As the medical community continues to seek solutions for chronic pain, ensuring treatments are grounded in robust scientific evidence remains crucial.
Caitlin Jones, a Postdoctoral Research Associate at the University of Sydney, and Christopher Maher, a Professor at the Sydney School of Public Health, emphasize the importance of informed decision-making in medical care.
