According to a Cochrane Study published today, spinal cord stimulation, a medical device indicated to treat persons with persistent back pain, may not give long-term relief and may cause harm.
Spinal cord stimulation is supposed to function by implanting a device that transmits electrical pulses to the spinal cord, preventing nerve impulses from reaching the brain.
The research looked at published clinical data on spinal cord stimulation. These includes randomised controlled trials, which are regarded as the most reliable means of determining the efficacy of a treatment in medical research.
The researchers examined data from 699 patients in 13 clinical studies that compared spinal cord stimulation therapy with placebo or no treatment for low back pain.
Researchers, medical professionals, and politicians trust Cochrane reviews because they utilize strong procedures to incorporate information from numerous sources, limiting the influence of bias and random error that can make individual studies less credible.
The review indicated that spinal cord stimulation is no better than a placebo for treating low back pain, with little to no effect or increase 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 unpleasant side effects of the procedure were generally underdocumented, preventing them from determining the amount of risk involved. The risks of spinal cord stimulation include nerve injury, infection, and the electrical leads shifting, which may necessitate additional procedures.
The findings of the inquiry have been forwarded to the Federal Department of Health and Aged Care’s prosthetic list review taskforce. The taskforce is examining the eligibility of current Medicare-subsidized prostheses.
The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic products, is also re-evaluating the devices’ long-term safety and performance.
“Spinal cord stimulation is invasive and has a high financial cost for those who chose surgery as a last option to relieve their pain. “Our assessment discovered that the long-term benefits and risks are mostly unclear,” stated 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 analysis of the clinical evidence reveals no persistent advantages to the procedure justify the costs and dangers.
“Low back pain is one of the primary causes of disability across the world. Our findings highlight the critical need to reform chronic pain funding arrangements in order to assist patients in their search for treatment. There are physical and psychological treatments for back pain that are evidence-based; providing access to them is critical.”
The study team discovered several 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 study was a single six-month period.
The bulk of clinical trials simply looked at the device’s immediate impact, which was less than a month.
The review committee made many suggestions, including that future spinal cord stimulation clinical studies be at least 12 months long, that the number of persons who have adverse effects be thoroughly documented, and that comparisons with alternative pain treatment choices be made.
Sydney Musculoskeletal Health Co-Director Professor Chris Maher stated:
“Our analysis indicated that the therapeutic effect of adding spinal cord stimulation to treat low back pain remained uncertain. When combined with the fact that these devices are incredibly costly and frequently fail, there is certainly a problem here that regulators should be concerned about.”
A separate Cochrane evaluation, in which the researchers were not engaged, looked at the effectiveness of spinal cord stimulation vs placebo in persons suffering from chronic pain. It found, similarly to this evaluation, that there was a lack of data to support long-term advantages in treating chronic pain.
Source: University of Sydney
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