UK clinical trial will assess MR-guided focused ultrasound as treatment for back pain caused by facet joint disease
Interview with Wladyslaw Gedroyc, M.D., St. Mary’s Hospital, London, England
The Focused Ultrasound Surgery Foundation has awarded a $232,808 research award to Wladyslaw M. Gedroyc, M.D. of St. Mary’s Hospital in London for a two-year randomized clinical trial comparing MR-guided focused ultrasound with radiofrequency ablation in the treatment of back pain caused by facet joint disease.
The clinical trial marks the next step in Gedroyc’s pioneering efforts to develop a noninvasive treatment for facet joint disease that provides more complete and longer lasting pain relief than current therapies. He and his team at St. Mary’s Hospital have already conducted a non-randomized pilot clinical trial in which MR-guided focused ultrasound was used to treat 17 patients suffering from extreme back pain caused by facet joint osteoarthritis. Post-treatment assessments show the technology is safe and effective.
“The follow-up data that we have collected is very promising, with up to 60 percent reduction in pain and a similar level of reduction in the level of disability, as measured by NRS and Oswestry Disability Index scores,” Gedroyc says.
The start date of the clinical trial will be determined following the approval of the study protocol by the ethics committee at St. Mary’s Hospital.
Gedroyc says, “It is difficult to estimate how many people suffer from facet joint disease because chronic back pain is large mish-mash of many pathologies. One of the big problems is that people are often treated for facet disease when they may have other problems of the back.”
For this reason, the studies at St. Mary’s only recruit patients who have demonstrated a definite response to a previous facet intervention. “By a ‘facet intervention’ I mean something like a local anesthetic or steroid injection close to the facet join, or a joint injection of steroids, or possibly a radiofrequency ablation of the nerves around there,” Gedroyc explains. Radiofrequency ablation, he says, is the current gold standard for facet joint treatment.
The new technique uses MR-guided focused ultrasound to destroy nerve structures in degenerative facet joints. “We simply heat up the facet joints with focused ultrasound in a noninvasive manner so that we destroy the nerve bundles along the posterior aspect of the facet joint,” Gedroyc says. “We believe these nerve bundles are instrumental in causing pain from facet joint disease.”
If clinical trials are successful, he adds, “It means that we will have created a method of treating facet joints with an entirely noninvasive modality. No radiation will be involved. Just an MR scan using focused ultrasound. So, the patient would come in, lie down on the table, we would treat probably three facet joints on each side, and they will walk out. And we anticipate that we could do this in about half an hour or so. If it is long-lasting, then we have a huge potential for improving the way patients are treated, requiring no more injections.”
Key developments and information related to the randomized clinical trial at St. Mary’s will be covered in future issues of this newsletter.
Written by Ellen C., McKenna