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Spinal cord stimulation no better than placebo stimulation for chronic pain after lumbar spine surgery
Clinical Question
Is spinal cord stimulation effective for managing chronic pain in adults after lumbar spine surgery?
Bottom line
This study found active spinal cord stimulation to be no better than placebo stimulation for reducing chronic radicular pain in adults after lumbar spine surgery. 1b
Reference
Study design: Cross-over trial (randomized)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
Surgically implanted spinal cord stimulators are frequently used to manage chronic pain after lumbar spine surgery. These investigators identified 50 adults, 18 years or older, with a history of at least 1 decompressive or fusion surgery for degenerative lumbar spine disease, postoperative chronic radicular pain refractory to nonsurgical management for at least 6 months, and an average pain intensity of at least 5 on a scale of 1 to 10 (where 0 = no pain, and 10 = the "worst pain imaginable"). Eligible patients included those reporting sufficient improvement in leg pain during a testing period using an external neurostimulator with spinal cord lead placement targeting the desired dermatomes. After surgical placement of an implanted pulse generator using the same spinal cord leads, study participants underwent two 3-month treatment periods of standard burst stimulation and two 3-month periods of placebo stimulation in a randomized order. After the treatment periods, study personnel ascertained that stimulation capable of achieving perception threshold measurements still occurred in the desired spinal dermatomes. Individuals masked to treatment group assignments assessed outcomes using a standardized validated back pain–related disability scoring tool. At least one follow-up evaluation occurred for 94% of study patients, with full case analysis occurring for 84%. Both treatment groups significantly improved compared with baseline (mean change -10 points on a scale of 0 to 100), with no significant between-group difference. In addition, no significant group differences occurred for any of the multiple secondary outcomes. Of importance, the participants' guesses at treatment group allocation at the end of each randomization period were correct only 58% of the time.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
chronc low back pain
carry on
Sorry but I don't understand…
Sorry but I don't understand how you can do a "fake" stimulation... What's the difference between the real and placebo stimulation?
Problematic study design
When the screening process for the trial involves a positive response to a tonic stimulation (stimulation that is felt) and then the randomized component is testing if patients respond to burst (below the sensation threshold) stimulation (which animal models suggests stimulates different pathways than tonic stimulation) vs placebo, the study cannot be generalized to conclude that all SCS is no different than placebo. This study’s conclusion is analogous to selecting patients for a study on treatment of depression based on their 3 day response to intermittent IV Ketamine, then randomizing them to sertraline vs placebo, having a result that shows no difference, then publishing the conclusion that ALL antidepressants of all classes are no different from placebo.
spinal stim post lumbar surgery
no better than sham stim