Jump in with Both Feet?
An implanted (read invasive) spinal cord stimulator has recently been approved by the FDA for refractory painful diabetic neuropathy (PDN). The approval was based on a clinical trial of patients who did not respond to at least two classes of medications used to treat neuropathic pain. Most had suboptimal control of their diabetes.
Eighty percent had reduction of pain by half or better compared to 5% of those treated with oral or topical medications. Over 60%, compared to 3% in the medical management only group, had improvement in function on neurological examination.
The results were termed “dramatic” or even “miraculous” by independent expert reviewers. They cautioned that an “open label” pain study is highly susceptible to placebo responses, especially when studying a device. Also, there is no established scientific reason for the stimulator to improve neurological function. Further, studies supported by the manufacturers of medical devices carry potential conflicts of interest.
There’s more. In 2020, the FDA issued a letter to health care providers detailing reports of over 400 deaths connected with spinal cord stimulators, as well as over 30,000 reports of unsatisfactory pain relief, between 2016 and 2020, for indications other than diabetic neuropathy.
With an implanted device, you can’t just get your toes wet. Before you jump in, you may wish to wait for placebo-controlled studies with “sham” stimulation.
Adapted from Neurology Today, August 18, 2022.
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