Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study).

BACKGROUND: While the evolution of technology provides new opportunities to manage chronic refractory pain using different waveform modalities of spinal cord stimulation in failed back surgery syndrome (FBSS), there is no randomized controlled trial available to compare the efficacy of these different stimulations waveforms to date. MULTIWAVE is a prospective, randomized, double-blinded, crossover trial study designed to compare the clinical efficacy of tonic conventional stimulation (TCS), burst stimulation (BURST) and high-frequency stimulation (HF) in FBSS patients over a 15-month period in SCS implanted patients. METHODS/DESIGN: Twenty-eight patients will be recruited in the Poitiers University Hospital, in Niort and La Rochelle Hospitals in France. Eligible patients with post-operative low back and leg pain with an average visual analog scale (VAS) score ≥ 5 for low back pain are implanted and randomly assigned to one of the six arms (in a 1:1:1:1:1:1 ratio), where they receive a 3-month combination of TCS, BURST and HF including one treatment modality per month and varying the order of the modality received within the six possible combinations. Patients receiving intrathecal drug delivery, peripheral nerve stimulation and back resurgery related to the original back pain complaint and experimental therapies are excluded from this study. Patients included in the spinal cord stimulation group undergo trial stimulation, and they all receive a TCS treatment for 2 months, as the gold standard modality. Thereafter, patients are randomly assigned to one of the six arms for the total duration of 3-month crossover period. Then, patients choose their preferred stimulation modality (TCS, BURST, or HF) for the follow-up period of 12 months. Outcome assessments are performed at baseline (first implant), before randomization (2 months after baseline) and at 1, 2, 3, 6, 9 and 15 months post-randomization. Our primary outcome is the average global VAS of pain over 5-day pain diary period between baseline and after each period of stimulation. Additional outcomes include changes in leg and back pain intensity, functional disability, quality of life, psychological state, paraesthesia intensity perception, patient satisfaction and the number of adverse events. DISCUSSION: Recruitment began in February 2017 and will continue through 2019. TRIAL REGISTRATION: Clinicaltrials.gov NCT03014583 . Registered on 9 January 2017.

Back pain: a real target for spinal cord stimulation?

BACKGROUND: Failed back surgery syndrome represents one of the most frequent etiologies of chronic back pain and is a major public health issue. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS) systems. New-generation leads using several columns of stimulation can generate longitudinal and/or transverse stimulation fields into the spinal cord. OBJECTIVE: To investigate, through extensive stimulation testing, the capacity of multicolumn tripolar leads to achieve back territory paresthesia coverage in refractory failed back surgery syndrome patients. METHODS: Eleven patients implanted with a 16-contact spinal cord stimulation lead (Specify 5-6-5, Medtronic Inc) were assessed with a systematic exploration of 43 selected stimulation configurations to generate bilateral back paresthesia in addition to leg territory coverage. RESULTS: The tripolar lead successfully generated paresthesia in both bilateral back and leg territories in 9 patients (81.8%). Success rates of multicolumn stimulation patterns were significantly higher than for longitudinal configurations for lombodorsal paresthesia coverage. Six months after implantation, significant pain relief was obtained compared with preoperative evaluation for global pain (Visual Analog Scale, 2.25 vs 8.2 preoperatively; P < .05), leg pain (Visual Analog Scale, 0.5 vs 7.6 preoperatively; P < .05), and back pain (Visual Analog Scale, 1.5 vs 7.8 preoperatively; P < .05). CONCLUSION: These results suggest that multicolumn leads can reliably generate back pain coverage and favor pain relief outcomes. This may lead physicians to reconsider new indications for spinal cord stimulation. Expanding neurostimulation perspectives to intractable back pain syndromes could become realistic in the near future.