summary: A new study shows that spinal cord stimulation does not provide long-term back pain relief and may actually harm patients.
sauce: University of Sydney
Spinal cord stimulation, a medical technique proposed to treat chronic back pain, doesn’t provide long-term relief and can be harmful, says one researcher. cochrane review Released today.
Spinal cord stimulation is thought to work by implanting a device that delivers electrical pulses. spinal cord It blocks nerve signals before they reach the brain.
This study reviewed published clinical data on spinal cord stimulation. This included randomized controlled trials, considered to be the definitive way to measure the effectiveness of treatments in medical research.
Researchers analyzed the results of 13 clinical trials, examining data from 699 participants, and compared spinal cord stimulation with placebo or no treatment for back pain.
cochrane review Researchers, health professionals and policy makers to combine evidence from multiple sources using robust methodologies and reduce the effects of bias and random errors that can undermine the reliability of individual studies. Trusted by
The review concludes that spinal cord stimulation is not superior to placebo in treating low back pain and probably has little or no effect on people with low back pain or improving quality of life.
There were little or no clinical data regarding the long-term efficacy of spinal cord stimulation.
The researchers also found that adverse side effects to surgery were overall poorly documented, preventing them from concluding the level of associated risk. injury, infection, and dislocation of electrical leads, all of which may require repeat surgery.
The results of the review have been submitted to the Federal Department of Health and the Aged Care Prosthetic List Review Task Force. The task force is reviewing the eligibility of current Medicare-sponsored prosthetics.
In Australia, the long-term safety and performance of the device is also being re-evaluated by the Therapeutic Goods Administration (TGA), the country’s regulatory agency for therapeutic products.
“Spinal cord stimulation is invasive and carries a significant financial cost to those who choose surgery as a last resort for pain relief. In our review, long-term benefits and harms are essentially unknown. It turned out that
“Our review of clinical data suggests that no sustained benefits of surgery outweigh the costs and risks.
“Back pain is one of the leading causes of disability worldwide. It further emphasizes that there are evidence-based physical and psychological therapies for back pain, and ensuring access to them is essential.”
The review team found multiple gaps in the clinical data.
No studies investigated the long-term (more than 12 months) effects of spinal cord stimulation on low back pain. The longest was one of his six-month trials.
The majority of clinical trials only examined the immediate effects of the device, a timeframe of less than one month.
The review team produced a list of recommendations that included conducting prospective spinal cord stimulation clinical trials for at least 12 months, clearly documenting the number of people experiencing adverse events, and comparing with other pain treatment options. provided.
Professor Chris Maher, co-director of Sydney Musculoskeletal Health, said: Combined with the fact that these devices are very expensive and often fail, there are clear issues here that regulators should be concerned about. “
another cochrane review, investigator-uninvolved, examined the effects of spinal cord stimulation versus placebo in people with chronic pain. Similar to this review, we concluded that evidence to suggest long-term benefits in treating chronic pain is lacking.
About this Neurotech and Pain Research News
author: press office
sauce: University of Sydney
contact: Press Office – University of Sydney
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Original research: open access.
“spinal cord stimulation for back pain” Adrian Traeger et al. Cochrane database of systematic reviews
spinal cord stimulation for back pain
Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals to the spinal cord via implanted electrodes. The long-term benefits and harms of SCS for low back pain patients are unknown.
To assess the effects (including benefits and harms) of SCS for patients with low back pain. Search strategy:
We searched CENTRAL, MEDLINE, Embase, and one other database for trials published on 10 June 2022. We also searched his three clinical trial registries for ongoing trials.
We included all randomized controlled trials and crossover trials comparing SCS with placebo or no treatment for low back pain. The primary comparison was his SCS versus placebo at the longest time point measured in the trial. Primary outcomes were mean back pain intensity, functioning, health-related quality of life, global effectiveness assessment, withdrawal due to adverse events, adverse events, and serious adverse events. Our primary time point was long-term follow-up (≥12 months).
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
We included 13 studies involving 699 participants. His 55% of participants were female. The average age ranged from 47 for her to 59 for him. All participants also had chronic low back pain, and the average duration of his symptoms ranged from 5 to 12 years. Ten crossover trials compared SCS with placebo. Three parallel group trials evaluated the addition of her 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, such as lack of explanation for duration and carryover effects.
Two of the three parallel trials evaluating SCS as an addition to medical management were at risk of attrition bias, and all three had substantial crossover to the SCS group at >6 months. I was. We considered the lack of placebo control to be an important source of bias in the parallel-group trials.
None of the included studies evaluated the effect of SCS on long-term (≥12 months) mean low back pain intensity. The studies most often assessed outcomes over short periods of time (<1 month).
The only evidence available at 6 months came from a single crossover trial (50 participants). There was moderate-certainty evidence that SCS probably did not improve back or leg pain, function, or quality of life compared to placebo. Pain improved by 61 points (0-100 point scale, 0 = no pain) at 6 months on placebo and by 4 points (8.2 points improved to 0.2 points worsened) on SCS.
Functioning was 35.4 points (on a 0-100 point scale, 0 = no impairment or best functioning) at 6 months on placebo and 1.3 points (3.9 points better to 1.3 points worse) on SCS. Health-related quality of life improved by 0.44 points out of 1 at 6 months in the placebo group (on a scale of 0 to 1, 0 = worse quality of life) and by 0.04 points in SCS (improved by 0.16 points to worsened by 0.08 points) was.
In the same study, 9 participants (18%) experienced adverse events and 4 (8%) required reoperation. Serious adverse events associated with SCS include infections, neurological damage, and lead migration requiring repeat surgery. As no placebo-period events were reported, relative risk effect estimates could not be provided.
Parallel trials evaluating SCS in addition to medical management will explore whether SCS can reduce back pain, leg pain, or health-related quality of life in the medium- to long-term, or whether it increases the number of people. The certainty of the evidence was very low, reporting improvements of 50% or more.
Low-certainty evidence suggests that the addition of SCS to medical management may modestly improve function and modestly reduce opioid use. In the medium term, mean functioning (0-100 point scale; lower is better) improved by 16.2 points with the addition of SCS to medical management compared to medical management alone (95% confidence interval (CI) improved by 19.4 points to 13.0).Better than the point; i2 = 95%; 3 studies, 430 participants. low-certainty evidence).
The number of participants reporting opioid medication use was reduced by 15% with the addition of SCS to medical management (95% CI 27% reduction to 0% reduction; I2 = 0%; 2 studies, 290 participants. low-certainty evidence). Adverse events with SCS were reported infrequently, but included infections and lead transfers. One study found that at 24 months, 13 of his 42 (31%) who had SCS required revision surgery.
Due to the very low certainty of the evidence, it is unclear to what extent the addition of SCS to medical management increases the risk of withdrawal due to adverse events, adverse events, or serious adverse events.
The data in this review do not support the use of SCS to manage low back pain outside of clinical trials. Current evidence suggests that SCS probably has no lasting clinical benefit that outweighs the costs and risks of this surgical intervention.