Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Non-Invasive Cortical Electrostimulation in the Treatment of Fibromyalgia.
Hargrove2, Jeffrey B., Bennett5, Robert M., Simons1, David G., Smith3, Susan J., Nagpal3, Sunil, Deering4, Donald E.
The purpose of this study was to test the feasibility, efficacy and safety of an innovative form of non-invasive cortical electrostimulation (NICE) in the treatment of fibromyalgia (FM), where areas of the brain that may be involved in dysfunctional sensory processing were targeted.
A randomized placebo controlled, double-blind trial design was used to evaluate the efficacy of NICE in 77 FM patients (ACR 1990 criteria). Non-invasive leads were applied to the scalp with the aim of stimulating the centro-parietal area, including the somatosensory cortex. Monopolar electrical stimulation was used that employed high frequency carrier components to overcome skin and scalp impedance, and low frequency components designed to stimulate and modulate lower frequency cortical activity in the targeted areas. NICE consisted of 22 treatment sessions administered twice a week for approximately 11 minutes. As the signal is sub-threshold for cutaneous stimulation, the placebo arm (PL) was created by simply not delivering the signal. Patients were evaluated at baseline and no less than 7 days after completion of therapy. At both time-points all subjects completed the FIQ and a sleep VAS. A blinded investigator evaluated the number of positive tender points (TePs), and the summated tender point pain threshold (TPPT) was assessed using dolorimetry. The FIQ was re-administered at an average of 17 months post-termination of the study.
Baseline demographic and clinical features were comparable in both treatment groups. Compared to PL, the NICE group had a significant improvement in the total FIQ score, pain VAS and sleep VAS scores. NICE group patients improved in the number of positive TePs (~ 43%), whereas the PL group did not change. The pain threshold (TPPT) for the NICE group improved 61% whereas the control group got slightly worse (-4%). Between-group analysis of TePs and TPPT scores showed significant improvement in the NICE arm compared to PL. Long-term follow-up showed a sustained improvement in the FIQ scores over baseline (average total FIQ scores: baseline 59, post-treatment 42; long-term 37; p < 0.001). NICE did not result in any significant adverse events.
|Baseline to Post-Treatment Outcomes [Mean Raw Change (% change)]||NICE Group||PL Group|
|Number of positive TePs (range 018)||-7.4 (-43%), p < 0.001||-0.2 (0%), p = 0.68|
|Post-therapy group difference in number of positive TePs||-6.8 (41%, p < 0.001)|
|Change in TPPT (range 972)||+19.7 (61%)||-3.1 (-4%)|
|p < 0.001||p = 0.04|
|Post-therapy group difference in TPPT||+20.8 (37%, p < 0.001)|
|Post-therapy change in FIQ pain||-2.0 (30%)||-0.6 (9%)|
|VAS (range 010)||p < 0.001||p = 0.20|
|Post-therapy group difference in FIQ pain VAS||-1.4 (23%, p = 0.02)|
|Post-therapy change in total FIQ||-15.5 (25%)||-5.5 (9%)|
|score (range 0100)||p < 0.001||p = 0.052|
|Post-therapy group difference in total FIQ score||-6.5 (12%, p = 0.03)|
|Percent of patients achieving 30% reduction in TePs||66%||5%|
|Percent of patients achieving 30% improvement in TPPT||71%||8%|
|Percent of patients achieving 30% improvement in Total FIQ||39%||20%|
|Percent of patients achieving 30% improvement in FIQ pain VAS||53%||29%|
Using a cortical electrostimulation technique specifically designed to enhance signal penetration to centro-parietal brain regions, this study yielded clinically significant improvements in pain, tenderness and other typical features of FM. The treatment was well tolerated without significant adverse effects. This modality may augment current approaches to the treatment of FM.
To cite this abstract, please use the following information:
Hargrove, Jeffrey B., Bennett, Robert M., Simons, David G., Smith, Susan J., Nagpal, Sunil, Deering, Donald E.; Non-Invasive Cortical Electrostimulation in the Treatment of Fibromyalgia. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :647