Background
Spinal cord stimulation (SCS) is a surgical intervention thought to modulate pain by sending electrical signals via implanted electrodes into the spinal cord. We aimed to assess the benefits and harms of SCS for people with low back pain.
Search methods
On 10 June 2022, we searched CENTRAL, MEDLINE, Embase, and one other database for published trials. We also searched three clinical trials registers.
Selection criteria
We included all randomised 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.
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Main results
We included 13 studies with 699 participants: 55% of participants were female; mean age ranged from 47 to 59 years; and all participants had chronic low back pain with mean duration of symptoms ranging from five to 12 years. Ten cross‐over trials compared SCS with placebo. Three parallel‐group trials assessed the addition of SCS to medical management.
Most studies were at risk of performance and detection bias from inadequate blinding and selective reporting bias. The placebo‐controlled trials had other important biases, including lack of accounting for period and carryover effects. Two of the three parallel trials assessing SCS as an addition to medical management were at risk of attrition bias, and all three had substantial cross‐over to the SCS group for time points beyond 6 months.
None of our included studies evaluated the efficacy of SCS on mean low back pain intensity in the long term (≥ 12 months). The studies most often assessed outcomes in the immediate term (less than one month). At 6 months, the only available evidence was from one cross‐over trial (n=50) which provided moderate‐certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo. Serious adverse events with SCS included infections, neurological damage, and lead migration requiring repeated surgery.
Conclusions
Data in this review do not support the use of SCS to manage low back pain outside a clinical trial.