Failed Back Surgery Syndrome Clinical Trial
Official title:
A Novel Approach in Spinal Cord Stimulation: a Combination of Burst and Tonic Waveforms.
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves used in Spinal Cord Stimulation are mainly Tonic or Burst. Both Tonic and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS. The aim of our study is to evaluate the efficacy of a new stimulation paradigm with the combination of the two wave forms.
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic
pain for decades. One of the most general indication for SCS is Failed Back Surgery Syndrome
with associated legs and/or low back pain.
Conventional low frequency neurostimulation is applied with a tonic wave shape (pulse width
is usually 300 to 500 μsec, amplitude 2 to 5 mA, and frequency 40 to 50 Hz); this kind of
stimulation produces a perceptible paraesthesias in the area of stimulation "covering" the
region of pain. Further development in waves of stimulation during the recent years led to
new paradigms of sub-perception stimulation like "Burst" stimulation that has characteristics
of a cluster of waves with higher frequency.
The efficacy of these two wave forms has been demonstrated by different authors. Both Tonic
and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the
Burst wave for the FBSS.
Recent advances in technology of the implantable devices for spinal cord stimulation led to
the possibility to combine the two stimulation waves described allowing the design of a
possible new paradigm of stimulation. The Tonic and Burst wave can be combined to stimulate
the same pain area using the same configuration otherwise they can be programmed to stimulate
two different pain areas with two different configurations. Both burst and tonic waveforms
paradigms can be customized according to patients' need. The characteristics of this combined
stimulation wave in terms of efficacy, non inferiority, energy consumption, and patient
satisfaction are unknown.
The primary objective of this trial is to compare pain suppressive effect of Low Frequency
"Tonic Wave" versus Low Frequency Combined "Burst and Tonic Wave" for Spinal Cord Stimulation
in subjects with refractory neuropathic leg and low back pain as result of FBSS.
Patients fulfilling the inclusion criteria will be enrolled in the study and receive
electrocatheter implant. Then, they will be observed for a two-weeks trial period in which
the efficacy of the stimulation and the compliance of the patient is evaluated. During this
trial a Tonic wave stimulation is administered by the external generator. After this trial,
the definitive generator will be implanted. Two weeks of Tonic stimulation will follow the
surgery to avoid any interference of the pain measurement with the surgical pain. After this
two weeks period, the stimulation will be switched into the combined waveform for 15 days. At
the end of the study period, the final waveform setting of the SCS will be in accord with the
patient's stimulation preference.
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