Key Points
- In this neuropathic facial pain clinical trial, the intervention failed to benefit study participants.
- The small cohort size may have limited the results.
In this small trigeminal neuropathic pain clinical trial, the focused ultrasound intervention used by researchers at the University of Virginia (UVA) failed to benefit the study participants.
The clinical trial (NCT 03309813) was conducted by the treatment team led by W. Jeffrey Elias, MD, professor of neurosurgery at UVA. The team used the Insightec Neuro focused ultrasound system to perform bilateral medial thalamotomies in 10 participants with trigeminal neuropathic pain. The study used contemporary MRI-guidance techniques and a double-blind, randomized controlled clinical trial design with a sham treatment group.
The target for the treatment group (five participants) was the central lateral nucleus. The other five participants who randomized into the control group received sham procedures with no energy administered. Researchers analyzed between-group differences in pain intensity before the procedure and 3 months later. Neither group had a significant improvement in pain intensity during the trial period. Although some of the participants in the treated group reported a benefit at 1 week, the procedures ultimately did not reduce the intensity of their trigeminal neuropathic pain.
“The 1-week benefit did not appear to represent a placebo response because it was not observed in the sham group,” said Dr. Elias. “This study was designed to control for observer bias and placebo response in patients with various types of trigeminal neuropathic pain.”
The authors cautioned that the small cohort may have limited the results and suggested that a larger study might shed more details on the findings.
Publishing results from studies with outcomes that are different from what was expected (“null results”) is incredibly valuable for advancing science. While it is important to know when studies achieve their endpoints, it is equally critical to learn when they do not so that researchers can change parameters and devise new theories and approaches to make measurements or fundamental constants more reliable.
This study was conducted at the UVA Focused Ultrasound Center and funded by the Commonwealth of Virginia through advocacy efforts of the Focused Ultrasound Foundation.
See the Journal of Neurosurgery (Open Access)
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