Summary: According to a new study, spinal cord stimulation does not provide long-term relief from back pain and may actually harm the patient.
Source: University of Sydney
According to a Cochrane Review published today.
Spinal cord stimulation is thought to work by implanting a device that sends electrical impulses to the spinal cord to interrupt nerve signals before they reach the brain.
The study reviewed published clinical data on spinal cord stimulation. This included randomized controlled trials, considered the most robust method of measuring treatment effectiveness in medical research.
The researchers analyzed the results of 13 clinical trials, examining data from 699 participants, comparing spinal cord stimulation treatment with placebo or no treatment for low back pain.
Cochrane Reviews are trusted by researchers, healthcare professionals, and policymakers because they use robust methodologies to combine evidence from multiple sources, reducing the impact of bias and random errors that can make individual studies less reliable .
The review concluded that spinal cord stimulation is no better than placebo for treating low back pain, with probably little or no benefit for people with low back pain or improving their quality of life.
There was little or no clinical data regarding the long-term effectiveness of spinal cord stimulation.
The researchers also found that the adverse side effects of the surgery were generally poorly documented, preventing them from concluding on the level of risk involved. Damage from spinal cord stimulation can include nerve damage, infection, and displaced electrical wires, all of which may require repeat surgeries.
The findings of the review were submitted to the Federal Department of Health and Aged Care Prosthetics List Review Task Force. The task force is reviewing the eligibility of current Medicare-funded prostheses.
In Australia, the long-term safety and performance of devices is also being reassessed by the Therapeutic Goods Administration (TGA), the country’s regulatory authority for therapeutic products.
“Spinal cord stimulation is invasive and comes at a significant financial cost for people who choose surgery as a last resort for pain relief. Our review found that the long-term benefits and harms are essentially unknown,” said lead researcher Dr Adrian Traeger of Sydney Musculoskeletal Health, an initiative of the University of Sydney, Sydney Local Health District and from the North Sydney Local Health District.
“Our review of clinical data suggests that no lasting benefit of surgery outweighs the costs and risks.
“Lumbago is one of the leading causes of disability worldwide. Our findings further underscore the urgent need to revisit how chronic pain care is funded to help patients in their search for relief. There are evidence-based physical and psychological therapies for back pain; ensuring access to these is essential.
The review team found multiple gaps in the clinical data.
No studies have looked at the long-term impact (more than 12 months) of spinal cord stimulation on low back pain. The longest was a single six-month trial.
The majority of clinical trials have only looked at the immediate impact of the device, i.e. over a period of less than a month.
The review team provided a list of recommendations, including that future clinical trials of spinal cord stimulation last at least 12 months, clearly document the number of people who experience adverse events, and make comparisons with others. other pain treatment options.
Professor Chris Maher, co-director of Sydney Musculoskeletal Health, said: “Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often fail, there is clearly a problem here that regulators should be concerned about.
A separate Cochrane Review, in which the researchers were not involved, examined the effect of spinal cord stimulation versus a placebo in people with chronic pain. Similar to this review, it concluded that there was a lack of evidence to suggest long-term benefits in the treatment of chronic pain.
About this neurotechnology and pain research news
Author: Press office
Source: University of Sydney
Contact: Press Office – University of Sydney
Picture: Image is in public domain
Original research: Free access.
“Spinal Cord Stimulation for Low Back Pain” by Adrian Traeger et al. Cochrane Database of Systematic Reviews
Abstract
Spinal cord stimulation for low back pain
Background
Spinal cord stimulation (SCS) is a surgical procedure used to treat persistent low back pain. The SCS is thought to modulate pain by sending electrical signals through electrodes implanted in the spinal cord. The long-term benefits and harms of SCS for people with low back pain are uncertain.
Goals
To assess the effects, including benefits and harms, of SCS for people with low back pain.
Research methods
On 10 June 2022, we searched CENTRAL, MEDLINE, Embase and another database for published trials. We also searched three clinical trials registers for ongoing trials.
See also
Selection criteria
We included all randomized controlled trials and cross-over trials comparing SCS with placebo or no treatment for low back pain. The primary comparison was SCS versus placebo, at the longest time point measured in the trials. The primary outcomes were mean low back pain intensity, function, health-related quality of life, global efficacy assessment, withdrawals due to adverse events, adverse events and serious adverse events. Our main moment was the long-term follow-up (≥ 12 months).
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Principle results
We included 13 studies with 699 participants: 55% of participants were women; the average age ranged from 47 to 59; and all participants suffered from chronic low back pain with an average duration of symptoms ranging from five to 12 years. Ten cross-over trials compared SCS with placebo. Three parallel group trials evaluated the addition of SCS to medical management.
Most studies were at risk of performance and detection bias due to inadequate blinding and selective reporting bias. Placebo-controlled trials had other important biases, including failure to account for period and carryover effects.
Two of the three parallel trials evaluating SCS as an adjunct to medical management were at risk of attrition bias, and all three had substantial overlap with the SCS group for periods beyond six months. In the parallel group trials, we considered the lack of placebo control to be an important source of bias.
None of our included studies assessed the impact of SCS on the mean intensity of long-term low back pain (≥ 12 months). Studies most often assessed short-term outcomes (less than one month).
At six months, the only evidence available was from a single crossover trial (50 participants). There was moderate-certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared to placebo. Pain was 61 points (on a scale of 0 to 100 points, 0 = no pain) at six months with the placebo, and 4 points (from 8.2 points better to 0.2 points worse) with the SCS.
Function was 35.4 points (on a scale of 0 to 100 points, 0 = no disability or better function) at six months with placebo, and 1.3 points better (3.9 points better at 1 .3 point worse) with SCS. Health-related quality of life was 0.44 points out of 1 (index of 0 to 1, 0 = worse quality of life) at six months with the placebo, and 0.04 points better (0.16 points better 0.08 point worse) with SCS.
In this same study, nine participants (18%) experienced adverse events and four (8%) required revision surgery. Serious adverse events with SCS included infections, neurological damage, and lead migration requiring repeat surgery. We could not provide relative risk effect estimates because events were not reported for the placebo period.
In parallel trials evaluating SCS as an adjunct to medical management, it is uncertain whether in the medium to long term, SCS can reduce low back pain, leg pain, or health-related quality of life, or if it increases the number of people reporting an improvement of 50% or more because the certainty of the evidence was very low.
Low-certainty evidence suggests that adding SCS to medical management may slightly improve function and slightly reduce opioid consumption. At medium term, mean function (0-100 point scale; lower is better) was 16.2 points better with the addition of SCS to medical management compared to medical management alone (range 95% confidence (CI) from 19.4 points better to 13.0 points better;2 = 95%; 3 studies, 430 participants; low-certainty evidence).
The number of participants reporting opioid use was 15% lower with the addition of SCS to medical management (95% CI 27% lower to 0% lower; I2 = 0%; 2 studies, 290 participants; low-certainty evidence). Adverse events with SCS were poorly reported, but included infection and lead migration. One study found that at 24 months, 13 of 42 people (31%) receiving SCS needed revision surgery.
It is uncertain to what extent adding SCS to medical management increases the risk of discontinuation due to adverse events, adverse events, or serious adverse events, as the certainty of the evidence was very weak.
Conclusions of the authors
The data in this review do not support the use of SCS to manage low back pain outside of a clinical trial. Current evidence suggests that SCS is unlikely to have lasting clinical benefits that would outweigh the costs and risks of this surgical procedure.