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Device calms Fibromyalgia symptoms
Sunday 14 November 2010
ACR: Device Calms Fibromyalgia Symptoms
ATLANTA -- Electrodes placed on the scalp to deliver weak, high-frequency currents significantly reduced symptoms of fibromyalgia in a double-blind, sham-controlled trial, a researcher said here.
Mean decline from baseline in Fibromyalgia Impact Questionnaire (FIQ) scores after 11 weeks of treatment was 15.5 points (95% CI 8.7 to 22.3) -- about a 25% drop -- compared with a 5.6-point decline (95% CI 0.1 to 11.2) in patients receiving sham treatment (P=0.03 between groups), said Jeffrey Hargrove, PhD, of Kettering University in Flint, Mich.
"Compared to sham treatment, NICE [noninvasive cortical electrostimulation] yielded clinically significant improvements in pain, tenderness, and other typical features of fibromyalgia," Hargrove told attendees during an oral presentation at the American College of Rheumatology's annual meeting here.
The technology is similar to, but distinct from, two other noninvasive electromagnetic therapies that have been tested in fibromyalgia -- transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (TDCS).
TMS uses magnets placed on the scalp to induce currents within the brain, wheres TDCS applies a high-density direct current across the cranium with external electrodes. Both can be felt by the patient, making it difficult to conduct a fully blinded trial.
With the weaker currents used in NICE, Hargrove explained, "patients never feel the signal at all."
But the main idea in all three approaches is the same: to use electrical currents to alter and normalize pain signaling pathways in the brain.
Leads are attached to the scalp above the frontal cortex and at the back of skull behind the ears, delivering the signal to the centroparietal area including the motor and sensory cortex, said Hargrove, who helped develop the technology and co-owns a company seeking to commercialize it.
In the study, 77 patients received a total of 22 treatments, given in sessions lasting about 11 minutes twice weekly.
Patients were randomized to active treatment or to sham treatment. Hargrove said the latter involved attaching the leads but not delivering the current. The signal was controlled by codes entered into a computer, allowing clinical staff as well as patients to be blinded to treatment assignments.
In addition to the significant difference in change in total FIQ scores between groups, the active-treatment group also showed significantly better outcomes in most individual FIQ domains including function, pain, fatigue, and sleep. Only in the FIQ stiffness subscale did the NICE treatment fail to show a significant advantage over the sham.
Hargrove and colleagues also counted the number of tender points and measured the tender-point pain threshold at baseline and after treatment.
On both parameters, the NICE therapy produced dramatic improvements while sham treatment had virtually no effect.
Tender point counts dropped by a mean of 7.4 (95% CI 6.0 to 8.9) with NICE treatment compared with a mean decline of 0.2 with the sham therapy (P<0.001).
Mean pain pressure threshold increased by 19.6 points (95% CI 16.9 to 22.3) on a dolorimeter with active treatment versus a 3.2-point decline in the sham group.
One prominent fibromyalgia researcher, Philip Mease, MD, of the University of Washington in Seattle, called the latter findings "remarkable."
"This is unusual to see this kind of change," he told Hargrove during the question-and-answer period following the talk.
Session moderator Daniel Clauw, MD, of the University of Michigan, commented that the findings weren't too good to be true.
"I'm not skeptical at all," he told MedPage Today. "This is the third study [to show improvements with electromagnetic treatments]."
He acknowledged that the mechanism of action is not fully known. "But that's true of all our therapies," he noted.
Clauw said it was plausible that electrical stimulation could affect pain transmission in descending pathways and yield the results Hargrove described.
"It's another addition to our armamentarium" if the technology is approved and becomes clinically available, he said, though he added that cost would be an issue.
The NICE system is investigational and no pricing has been determined. However, a course of TMS therapy for depression, which involves a similar number of treatments, typically costs about $10,000 and is seldom covered by insurance.
The study was supported by Cephelex.
Hargrove reported serving as chief scientific officer and owning equity in Cephelex.
Clauw reported no financial interests related to the study. He reported consulting relationships with AstraZeneca, Cypress, Forest, Lilly, Pfizer, UCB, and Wyeth.
The above originally appeared here.
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