This study evaluated the long-term outcomes of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) in fibromyalgia (FM) patients. These FM patients had been treated with RINCE twice weekly over a period of 11-weeks in 2006-2008, in a placebo controlled, double-blind study that targeted areas of the brain considered to be involved in central sensitization (Arthritis Rheum 2010;62(10 Suppl):269-70).
Under IRB-approval, subjects treated with RINCE were asked to complete an un-blinded follow-up survey that included the Fibromyalgia Impact Questionnaire (FIQ). Thirty-nine subjects were mailed surveys, 25 were returned (64%). In addition to the FIQ, survey responses provided patient self-reports on the duration of symptom improvement, incidence of side effects, and changes in pain medicine use and physician visits.
The average respondent age was 59 years (range 39-71); the average time since completion of therapy was 45 months (range 31-60). The mean total FIQ score was 53 at baseline, 36 at end-of-study (EOS) and 32 at follow-up (P<0.001). The change from baseline in FIQ scores at EOS and follow-up were significantly correlated (R=0.78, P<0.001). Subjects reported symptom improvements lasting at least two-years in pain (68%) sleep (56%) and fatigue (60%). Some 76% of treated subjects reported that they had reduced or completely eliminated medicine use for pain, and 71% indicate reduced or eliminated need to see physicians for FM (see pie charts). No post-treatment side effects were reported.
A high percentage of FM patients, who had been treated with RINCE , continued to experience a worthwhile level of improvement in FM symptoms at a 45-month follow-up. These sustained benefits were accompanied by significant reductions in pain medicine use and physician visits. Follow-up total FIQ scores demonstrated durability of treatment effect when compared to baseline and EOS. The strong correlation between total FIQ scores at EOS and follow-up suggests that the initial response to RINCE is predictive of a long lasting therapeutic benefit. Cortical electrostimulation is a non-pharmacological modality that shows some promise in the management of FM patients, and has the potential for future development.
Disclosure: J. B. Hargrove, Cerephex Corporation, 4 ; R. M. Bennett, None; D. J. Clauw, Cerephex Corporation, 5 .