Spinal Cord Stimulators: High Risk, Low Benefit

What is a spinal cord stimulator?

A spinal cord stimulator is an implanted device that helps to relieve pain by sending low levels of electricity into the spinal cord. The device itself consists of a stimulating wire (also called leads or electrodes) that is connected to a control unit called a generator. The generator is powered by a battery pack similar to that used for pacemakers. The stimulator is activated by a hand-held remote control.

Spinal cord stimulator surgery requires general anesthesia. Before surgery takes place, a one-week trial is typically conducted. For the purposes of the trial, temporary wires are placed into the patient’s back using a small needle. This gives the patient the opportunity to test how well the stimulation manages their pain. Trials are considered successful if they reduce pain by 50 percent or more. If that occurs, the patient receives a permanent stimulator.

Implantation of the stimulator requires incisions in both the back and waist. The stimulating wire is inserted into the back in the space between the spinal cord and vertebrae (the epidural space). The wire is connected to the generator which is placed under the skin near the waist.

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How well does the spinal stimulator implant work?

The Cleveland Clinic estimates that more than 30,000 people have spinal cord stimulators implanted each year. While some studies have shown that these devices can reduce chronic pain by 50 to 80 percent, a recent analysis that appeared in the JAMA Neurology casts doubt on the long-term effectiveness of the implants.

The authors of Long-term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared With Conventional Medical Therapy for Chronic Pain, conclude that “treatment with a spinal cord stimulator was not associated with a reduction in use of opioids, pain injections, radiofrequency ablation, or spine surgery at 2 years.” The analysis also found that 20 percent of patients experienced complications that required the device to be revised or removed.

An JAMA Neurology editorial that accompanied the analysis states that “evidence of clinical and public health effectiveness (of SCS) is limited due to small sample sizes or bias related to authors that receive income from SCS manufacturers.” The editors also state that JAMA Neurology’s analysis should not be interpreted as an “argument against the therapeutic effectiveness of SCS for reducing symptoms or improving daily function.”

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While it is true that some people have benefited from the use of spinal cord implants, anyone who is considering the surgery should be aware of the significant risks associated with these medical devices. Even proponents of the SCS’s believe that they should be considered only as a last resort for chronic pain sufferers who have exhausted all other alternative pain treatments.

What are the risks of complication associated with the surgery?

According to Spinal Cord Stimulator Infection: Approach to Diagnosis, Management, and Prevention, a review that appeared in Clinical Infectious Disease, authors found that:

Up to 40% of patients experience complications after implantation
Almost 50% of those who experienced complications required surgical revision or removal of the device

Complications of Spinal Cord Stimulator Implantation, an article published by The American Society of Regional Anesthesia and Pain Medicine (ASRA), states that biologic complications that result from SCS include:

Infection rates of 2% to 10%
neurologic injury
epidural hematoma
skin erosion
epidural fibrosis
dural puncture
pain
allergic reaction to the device

The article also states that the most common complications result from device-related issues. These include:

lead migration
lead breakage
over or under stimulation
intermittent stimulation
hardware malfunction
loose connections
battery failure
failure to communicate with the generator

Device malfunctions can result in additional surgeries to remove or replace the device. It can also lead to injury to the spinal cord and surrounding tissue. Other injuries reported included paralysis.

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Consumer advocacy group calls for action on spinal cord stimulators

In June 2020, the nonprofit consumer advocacy organization Public Citizen sent a letter to the FDA regarding their concerns related to spinal cord stimulators. These concerns were based on what they referred to as the FDA’s “dangerously lax regulatory oversight of high-risk implanted spinal cord stimulators for chronic pain relief” which “resulted in unnecessary harm to patients.” Among Public Citizen’s long list of concerns was that the “FDA in effect has dangerously treated most high-risk Class III spinal cord stimulators as lower-risk class II devices.” The organization requested that the FDA:

reclassify the stimulators with external transmitters as Class III devices
require controlled clinical trials for any future totally implanted spinal cord stimulators
reassess the safety of all these devices and remove any from the market if deemed necessary

In the FDA’s response letter, the agency cites what they refer to as “inaccuracies” in the claims made by Public Citizen. The letter also states that the agency “does not agree that a serious safety signal exists outside the known and mitigated risks associated with spinal cord stimulators at this time.”

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Spinal Cord Stimulators under fire in Australia

University of Sydney researcher Caitlin Jones was the lead researcher of a study that appeared in Journal of Patient Safety. The aim of the study was to analyze adverse effects of spinal cord stimulators that were reported to the Therapeutic Goods Administration between July 2012 and January 2019. (In Australia, it is the Therapeutic Goods Administration that is responsible for regulating guidelines for medical devices.) The study, Spinal Cord Stimulators: An Analysis of the Adverse Events Reported to the Australian Therapeutic Goods Administration, examined the 520 adverse events were reported during this period:

Of the adverse events reported, 93% met the criteria to be considered a serious adverse event
79% were rated as severe
13% were reported as life-threatening
56% involved device malfunction
80% resulted in surgical intervention
The ratio of removals to implants was 4 for every 10 implanted

Study authors state that their results “raise questions about the safety and utility of this approach to treating chronic intractable pain.” They also suggest that a “national registry to track the long-term safety of these devices is needed.”

Results of the study were included in an article entitled To hell and back: Devices meant to ease pain are causing trauma that appeared in the Sydney Morning Herald. Jones was interviewed for the article and said, “These devices are expensive, invasive, are causing problems and are frequently being removed. The safety data is damning, especially given that we aren’t sure whether the treatment is effective. Using treatments where the efficacy is unclear, but where there are significant harms, is a perfect storm.” The article also includes stories from patients who experienced complication after receiving SCS surgery.

Nick Christelis, president of the Neuromodulation Society of Australia, pushed back on those claims by stating that the devices come with only “minor risks”. He asserts that SCS are capable of delivering up to an 80 percent reduction in pain.

Spinal Stimulator Implants are very costly

The costs for a spinal cord stimulator trial is between $7500 and $8000 dollars. Medicare pays $33,000 for the surgical implant and private insurance pays about $58,000. The annual maintenance cost varies, depending on the number of complications, and ranges from $5000 to $22,000.

There are better alternatives than spinal cord stimulation for chronic pain

Cindy Perlin, CEO of the Alternative Pain Treatment Directory, weighs in:

Spinal cord stimulators are often recommended when other conventional pain treatments have failed, including after surgical interventions, especially back surgery, have failed to reduce pain or made things worse, and/or after an assortment of pharmaceuticals and injections have failed to help. At this point, spinal cord stimulators are promoted as a “last resort”.

The truth is that there are many safe, effective, noninvasive interventions that conventional medical providers fail to mention, including many that also work in the realm of electrical stimulation and those that work in other energy realms such as light and magnetics.

Electrical signals, magnetics and light penetrate tissue, so they can have therapeutic benefits without the need for surgical implantation.

The fact is that spinal cord stimulators merely provide a distracting sensory signal, much like a TENS unit. TENS (Transcutaneous Electrical Nerve Stimulation) units are inexpensive and don’t require surgical placement. Some pain patients find TENS units helpful however they are not my favorite device because they don’t do anything to facilitate recovery from pain.

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Below are some non-invasive devices that relieve pain and inflammation and promote tissue healing. Click on the links to learn more about them:

Neuromuscular Electrical Stimulation (NMES)

Photobiomodulation (also known as cold laser therapy, low level laser therapy, red/infrared light therapy)

Pulsed Electromagnetic Frequency (PEMF)

Frequency specific microcurrent therapy

Calmare Scrambler Therapy

There are also many other safe, effective treatments that promote pain relief aside from those involving devices, including acupuncture, biofeedback, chiropractic, herbal medicine, massage, mind/body interventions, nutritional medicine, physical therapy and much more. All of these therapies can be provided at much lower cost than a spinal stimulator implant. Search for articles on all of these topics HERE.

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Conclusion

Spinal cord stimulators have a high risk of doing harm and have shown little benefit in long term relief of chronic pain. There are many other, rarely mentioned therapies that provide more benefits with fewer risks. Use of these alternative would also be far less costly to the healthcare system than spinal cord stimulators.

Christine Graf is a freelance writer who lives in Ballston Lake, New York. She is a regular contributor to several publications and has written extensively about health, mental health, and entrepreneurship.

Cindy Perlin, is a Licensed Clinical Social Worker, certified biofeedback practitioner and chronic pain survivor. She is the founder and CEO of the Alternative Pain Treatment Directory and the author of T he Truth About Chronic Pain Treatments: The Best and Worst Strategies for Becoming Pain Free. She's located in the Albany, NY area, where she has been helping people improve their health and emotional well-being for over 30 years. See her provider profile HERE.