TY - JOUR
T1 - A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients
AU - Hargrove, Jeffrey B.
AU - Bennett, Robert M.
AU - Simons, David G.
AU - Smith, Susan J.
AU - Nagpal, Sunil
AU - Deering, Donald E.
N1 - Funding Information:
Funding: Funding for this research was provided by the McLaren Foundation and Kettering University (both of Flint, Michigan, USA). Neither agency played any active role in the design or execution of the study, nor do they have any financial interest in the work or the technology involved.
PY - 2012/1
Y1 - 2012/1
N2 - Objective. The aim of this multicenter study was to evaluate the efficacy, safety, and tolerability of noninvasive cortical electrostimulation in the management of fibromyalgia (FM). Design. A prospective, randomized, double-blind, placebo-controlled design was used. Setting. Subjects received therapy at two different outpatient clinical locations. Patients. There were 77 subjects meeting the American College of Rheumatology 1990 classification criteria for FM. Intervention. Thirty-nine (39) active treatment (AT) FM patients and 38 placebo controls received 22 applications of either noninvasive cortical electrostimulation or a sham therapy over an 11-week period. Outcome Measures. The primary outcome measures were the number of tender points (TePs) and pressure pain threshold (PPT). Secondary outcome measures were responses to the Fibromyalgia Impact Questionnaire (FIQ), Symptom Checklist-90 (SCL-90), Beck Depression Inventory-II, and a novel sleep questionnaire, all evaluated at baseline and at the end of treatment. Results. Intervention provided significant improvements in TeP measures: compared with placebo, the AT patients improved in the number of positive TePs (-7.4 vs -0.2, P<0.001) and the PPT (19.6 vs -3.2, P<0.001). Most secondary outcomes also improved more in the AT group: total FIQ score (-15.5 vs -5.6, P=0.03), FIQ pain (-2.0 vs -0.6, P=0.03), FIQ fatigue (-2.0 vs -0.4, P=0.02), and FIQ refreshing sleep (-2.1 vs -0.7, P=0.02); and while FIQ function improved (-1.0 vs -0.2), the between-group change had a 14% likelihood of occurring due to chance (P=0.14). There were no significant side effects observed. Conclusions. Noninvasive cortical electrostimulation in FM patients provided modest improvements in pain, TeP measures, fatigue, and sleep; and the treatment was well tolerated. This form of therapy could potentially provide worthwhile adjunctive symptom relief for FM patients.
AB - Objective. The aim of this multicenter study was to evaluate the efficacy, safety, and tolerability of noninvasive cortical electrostimulation in the management of fibromyalgia (FM). Design. A prospective, randomized, double-blind, placebo-controlled design was used. Setting. Subjects received therapy at two different outpatient clinical locations. Patients. There were 77 subjects meeting the American College of Rheumatology 1990 classification criteria for FM. Intervention. Thirty-nine (39) active treatment (AT) FM patients and 38 placebo controls received 22 applications of either noninvasive cortical electrostimulation or a sham therapy over an 11-week period. Outcome Measures. The primary outcome measures were the number of tender points (TePs) and pressure pain threshold (PPT). Secondary outcome measures were responses to the Fibromyalgia Impact Questionnaire (FIQ), Symptom Checklist-90 (SCL-90), Beck Depression Inventory-II, and a novel sleep questionnaire, all evaluated at baseline and at the end of treatment. Results. Intervention provided significant improvements in TeP measures: compared with placebo, the AT patients improved in the number of positive TePs (-7.4 vs -0.2, P<0.001) and the PPT (19.6 vs -3.2, P<0.001). Most secondary outcomes also improved more in the AT group: total FIQ score (-15.5 vs -5.6, P=0.03), FIQ pain (-2.0 vs -0.6, P=0.03), FIQ fatigue (-2.0 vs -0.4, P=0.02), and FIQ refreshing sleep (-2.1 vs -0.7, P=0.02); and while FIQ function improved (-1.0 vs -0.2), the between-group change had a 14% likelihood of occurring due to chance (P=0.14). There were no significant side effects observed. Conclusions. Noninvasive cortical electrostimulation in FM patients provided modest improvements in pain, TeP measures, fatigue, and sleep; and the treatment was well tolerated. This form of therapy could potentially provide worthwhile adjunctive symptom relief for FM patients.
KW - Cortical
KW - Electrical
KW - Fibromyalgia
KW - Noninvasive
KW - Pain management
KW - Stimulation
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U2 - 10.1111/j.1526-4637.2011.01292.x
DO - 10.1111/j.1526-4637.2011.01292.x
M3 - Article
C2 - 22233397
AN - SCOPUS:84862969232
SN - 1526-2375
VL - 13
SP - 115
EP - 124
JO - Pain Medicine
JF - Pain Medicine
IS - 1
ER -