Abstract
Background The use of sham interventions in randomized controlled trials (RCTs) is essential
to minimize bias. However, their use in surgical RCTs is rare and subject to ethical
concerns. To date, no studies have looked at the use of sham interventions in RCTs
in neurosurgery.
Methods This study evaluated the frequency, type, and indication of sham interventions in
RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms
of design and risk of bias.
Results From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions.
The most common indication for the RCT was the treatment of pain (67.1%), followed
by the treatment of movement disorders and other clinical problems (18.3%) and brain
injuries (12.2%). The most used sham interventions were saline injections into spinal
structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in
cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters
for a sham lesions was performed in 14.6%.
In terms of methodology, most RCTs using sham interventions were double blinded (76.5%),
9.9% were single blinded, and 13.6% did not report the type of blinding.
Conclusion Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and
to evaluate the efficacy of pain management methods, especially in spinal disorders.
The greatest proportion of sham-controlled RCTs involves different types of substance
administration routes, with sham surgery the less commonly performed.
Keywords
randomized controlled trials - neurosurgery - bias - sham
