Occipital Nerve Stimulation in Fibromyalgia: A Double-Blind Placebo-Controlled Pilot Study With a Six-Month Follow-Up

C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study

“…However, during minimal stimulation the effect was less prominent. In contrast to the previous study by Plazier and colleagues [15] the presumed inactive, i.e. sham effect of minimal stimulation seems to be effective, albeit less pronounced than higher amplitudes, since we could not obtain a significant difference between "minimal stimulation" and "subthreshold stimulation".…”

“…The preliminary promising results lead to a second randomized controlled study with a weekly cross-over in the trial phase between active and presumed non-active (i.e. .10 mA) stimulation during 10 weeks, followed by an open label follow up period in small population of 11 fibromyalgia patients [15]. A significant effect for effective stimulation compared to non-active stimulation, and to the baseline could be obtained during the trial stimulation for pain.…”

“…Patients were provided with an external pulse generator (Multiprogram Trial System, St Jude Medical, Plano TX, USA) with the instructions on how to use it. Patients received 5 programs to test in the first week after trial implantation (6 Hz, 10 Hz, 12 Hz, 20 Hz and 40 Hz, with a pulse width of 300 ms) [13,15]. Patients were capable of switching between the different stimulation programs and were able to 'turn on and off' the device at will, as well as adjusting the amplitude of stimulation.…”

“…This was followed up by a small pilot study in a placebo-controlled way [15], supporting the initial non-placebo-controlled study [13]. Guided by these positive results the authors performed a randomized double blinded controlled trial, with different doses in randomized order for periods of 2 weeks, and concluding with an open label followup.…”

Multitarget surgical neuromodulation: Combined C2 and auditory cortex implantation for tinnitus

“…After 3 months the beneficial effect of the TENS wears off. In view of the earlier beneficial effect of the TENS a trial is proposed with peripheral nerve field stimulation of the C2 dermatoma via the percutaneous insertion of a wire electrode (Octrode ® , SJMedical, Plano, Tx, USA) according to a technique previously described [14,50]. This technique has been successfully used in a small group of patients for somatosensory tinnitus [21].…”