Spinal cord stimulation is thought to work by implanting a device that sends electrical pulses to the spinal cord, preventing nerve signals from reaching the brain.
The research looked at published clinical data on spinal cord stimulation. This included randomised controlled trials, which are regarded as the most reliable method of determining the efficacy of a treatment in medical research.
The researchers examined data from 699 participants in 13 clinical trials that compared spinal cord stimulation treatment with placebo or no treatment for low back pain.
Researchers, medical professionals, and policymakers trust Cochrane reviews because they use robust methodologies to combine evidence from multiple sources, reducing the impact of bias and random error that can make individual studies less reliable.
The review concluded that spinal cord stimulation is no better than a placebo for treating low back pain, with little to no benefit or improvement in people’s quality of life.
There was little to no clinical evidence on the long-term efficacy of spinal cord stimulation.
The researchers also discovered that adverse side effects of the surgery were generally underdocumented, preventing them from determining the level of risk involved. The risks of spinal cord stimulation include nerve damage, infection, and the electrical leads moving, which may necessitate additional surgeries.
The findings of the review have been forwarded to the Federal Department of Health and Aged Care’s prosthesis list review taskforce. The taskforce is reviewing the eligibility of current Medicare-subsidized prostheses.
The Therapeutic Goods Administration (TGA), Australia’s regulatory authority for therapeutic goods, is also re-evaluating the devices’ long-term safety and performance.
“Spinal cord stimulation is invasive and expensive for people who choose surgery as a last resort to relieve their pain.” “Our review discovered that the long-term benefits and harms are largely unknown,” said lead researcher Dr Adrian Traeger of Sydney Musculoskeletal Health, a collaboration of the University of Sydney, Sydney Local Health District, and Northern Sydney Local Health District.
“Our review of the clinical data suggests that the surgery’s long-term benefits do not outweigh the costs and risks.”
“Low back pain is one of the leading causes of disability throughout the world.” Our findings highlight the critical need to review chronic pain funding arrangements in order to assist patients in their search for relief. There are physical and psychological therapies for back pain that are evidence-based; ensuring access to these is critical.”
The review team discovered numerous gaps in clinical data.
There were no studies that looked at the long-term (over a year) effects of spinal cord stimulation on low back pain. The longest trial was a single six-month period.
The majority of clinical trials only looked at the device’s immediate impact, which was less than a month.
The review team made several recommendations, including that future spinal cord stimulation clinical trials be at least 12 months long, that the number of people who experience adverse events be clearly documented, and that comparisons with other pain treatment options be made.
Sydney Musculoskeletal Health Co-Director Professor Chris Maher stated:
“Our review discovered that the clinical benefit of including spinal cord stimulation in the treatment of low back pain is unknown.” When combined with the fact that these devices are very expensive and frequently fail, there is clearly a problem here that regulators should be concerned about.”
A separate Cochrane review, in which the researchers were not involved, looked at the effectiveness of spinal cord stimulation versus placebo in people suffering from chronic pain. It concluded, similarly to this review, that there was a lack of evidence to suggest long-term benefits in treating chronic pain.
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