Pain Relief and Multidimensional Outcomes of Fast-Acting Subperception Spinal Cord Stimulation Therapy for Chronic Pain: The FAST Prospective, Multicenter Study.
Magdalena Anitescu, Eric Loudermilk, James North, Sayed Wahezi, Ajay Antony, Tim Leier, Drew Trainor, John Noles, Gregory Moore, Jennifer Lee, Julio Paez, Derron Wilson, Virginie Van Belleghem, Edward Goldberg
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引用次数: 0
Abstract
Introduction: Fast-acting subperception therapy in spinal cord stimulation (FAST-SCS) uses low-frequency, subthreshold stimulation to engage the dorsal column-mediated surround inhibition mechanism and thereby relieve pain. Our study was performed to better characterize the multidimensional long-term clinical outcomes of FAST-SCS therapy in patients with chronic low back and/or leg pain.
Methods: Our prospective, multicenter, single-arm, open-label trial, conducted at 12 pain management centers across the USA, included male and female patients with chronic low back pain with/without leg pain refractory to conservative therapy. All eligible patients received an SCS implant. Outcomes evaluated included pain relief, disability, mobility, health-related quality of life, sleep quality, depression, pain catastrophizing, and global impression of change.
Results: Fifty-six patients received a permanent SCS implant and 55 were activated with FAST-SCS therapy. At 12 months, 89% and 59% of patients achieved ≥ 50% and ≥ 80% pain relief, respectively (p < 0.0001), and pain intensity (verbal numerical rating scale) decreased by 4.9 ± 2.2 points (p < 0.0001). Significant improvements were observed in disability (Oswestry Disability Index - 24 ± 16 points, p < 0.0001) and endurance (6-Minute Walk Test + 73 ± 96 m, p < 0.0001), while mobility and balance improved without reaching statistical significance (Timed Up-and-Go test - 7.5 ± 37.5 s, p = 0.17). All psychosocial measures improved significantly at 12 months compared to baseline, with an increase in the EQ5D-5L index (+ 0.200 ± 0.182, p < 0.0001) and decreases in the Pittsburgh Sleep Quality index (- 3.96 ± 4.31, p < 0.0001), Pain Catastrophizing Score (- 13.3 ± 11.4, p < 0.0001), and Beck Depression Index (- 7.9 ± 10.0, p < 0.0001). At 12 months, 87% of patients reported being "much" or "very much" improved. Responses to FAST-SCS were at or above the minimal clinically important differences across all measured clinical dimensions.
Conclusion: This prospective study demonstrated that FAST-SCS provided statistically significant, multidimensional benefits across pain, disability, mobility, and psychosocial outcomes over 12 months in patients with chronic low back and/or leg pain. These findings support the use of FAST-SCS in this patient population.
期刊介绍：
Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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