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Background: Preventing disc degeneration remains a clinical challenge; patients experiencing chronic lumbar discogenic pain have limited treatment options. Minimally invasive intradiscal procedures such as allogeneic nucleus pulposus (NP) injection have the potential to fill the treatment gap between failed conservative care and spine surgery., Objectives: Our study sought to evaluate the magnitude and durability of improvement in back function in patients with chronic lumbar discogenic pain followed for 6 months after a single intradiscal injection of minimally manipulated, off-the-shelf processed NP allograft (VIA Disc NP®, VIVEX Biologics, Inc.) at up to 2 vertebral levels., Study Design: Single-arm, prospective, multicenter, pilot study., Setting: Academic and private practice outpatient clinics., Methods: A total of 29 patients with symptomatic lumbar discogenic pain refractory to conservative care who had a back function score of  40-80 points on the Oswestry Disability Index (ODI), ≥ 6 on an 11-point back pain Numeric Rating Scale (NRS-11) and corresponding imaging evidence of disc degeneration were enrolled. A single dose, intradiscal injection of approximately 100 mg of NP allograft mixed with sterile saline was administered to the affected level or levels., Results: The average ODI and NRS-11 improvements between baseline and 6-months postprocedure were 54.8% (95% CI, 41.3-68.3) and 52.9% (95% CI, 34.7-71.1) respectively (P < 0.001). A minimal clinically important difference of ≥ 30% improvement over baseline was achieved in 79% (22 of 28) and 68% (19 of 28) of patients for ODI and NRS-11, respectively. At 6-months postprocedure, 64% (18 of 28) of patients had an NRS-11 score ≥ 3., Limitations: This pilot study did not employ a concurrent control group and the clinical follow-up was limited to 6 months., Conclusions: These pilot findings demonstrate the feasibility of treating patients with symptomatic lumbar disc degeneration with a single intradiscal injection of allogeneic NP to provide significant and durable improvements in back function and pain.

Background: Measures of therapeutic efficacy in pain studies have historically focused on pain scores, such as the Visual Analog Scale (VAS) or the Numeric Rating Scale. However, pain scores capture a univariate measure of a multivariate condition present in patients with chronic pain, where the pain condition can affect activities of daily living, sleep, quality of life, and mood. Hence, examining composite endpoints, which incorporate outcomes from multiple facets of pain, may allow investigators to better assess improvements in chronic pain patients with various new treatments., Objectives: This trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc.), a miniature implanted pulse generator (micro-IPG), in the treatment of low-back pain and leg pain with spinal cord stimulation therapy., Study Design: This was a prospective, single arm, multicenter, open-label, postmarket study that followed patients for 90 days postimplantation of the Nalu Neurostimulation System., Setting: Patients were recruited from, and treated at, 15 US-based comprehensive pain centers., Methods: Patients with chronic, intractable, neuropathic pain of the back and/or leg(s), with a VAS pain score of at least 6 at the time of screening, were included. The micro-IPG was implanted per standard clinical practice. Patient-reported outcomes (PROs), including VAS pain scores, Oswestry Disability Index (ODI), Beck Depression Inventory, quality-of-life metric (EQ-5D-5L), Patient Global Impression of Change (PGIC), and sleep disturbance Patient-reported Outcomes Measurement Information System (PROMIS) were recorded. Literature-based minimal clinically important differences (MCIDs) were used to define the MCID responder rates as well as a composite endpoint analysis., Results: Ninety-four percent (94%) of the study patients reached the MCID in at least 2 of the PROs. Five out of 6 PROs demonstrated a responder rate of > 75%. Forty-nine percent (49%) of the patients were holistic responders, meaning they responded in each of the 6 outcome measures under consideration. Overall VAS pain scores reached the MCID in 86% of the patients. PGIC demonstrated the largest MCID responder rate: 100%. The ODI score reached the MCID in 94% of the patients; the BDI score reached the MCID rate in 84% of the patients; the EQ-5D-5L score reached the MCID in 77% of the patients; and the PROMIS score reached the MCID in 67% of the patients., Limitations: While this was a multicenter, prospective study, it was also a single arm, nonrandomized trial. The 35 study patients were only followed for 90 days post micro-IPG implant., Conclusion: In the face of improving spinal cord stimulation pain outcomes, composite PROs are likely to become more common in evaluating therapeutic response. Responder rates, defined by the MCID, may help to establish composite endpoints. Since MCID was achieved across a variety of endpoints indicates that treatment with the Nalu Neurostimulation System provided a robust treatment response.

Background: Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation., Objectives: We report here the results of an SCS clinical trial to treat chronic, low back and leg pain, with a micro-implantable pulse generator (micro-IPG)., Study Design: This was a single-arm, prospective, multicenter, postmarket, observational study., Setting: Patients were recruited from 15 US-based comprehensive pain centers., Methods: This open-label clinical trial was designed to evaluate the performance of the Nalu™ Neurostimulation System (Nalu Medical, Inc., Carlsbad, CA) in the treatment of low back and leg pain. Patients, who provided informed consent and were successfully screened for study entry, were implanted with temporary trial leads. Patients went on to receive a permanent implant of the leads and micro-IPG if they demonstrated a >= 50% reduction in pain during the temporary trial period. Patient-reported outcomes (PROs), such as pain scores, functional disability, mood, patient impression of change, comfort, therapy use profile, and device ease of use, were captured., Results: At baseline, the average pain Visual Analog Scale (VAS) score was 72.1 ± 17.9 in the leg and 78.0 ± 15.4 in the low back. At 90 days following permanent implant (end of study), pain scores improved by 76% (VAS 18.5 ± 18.8) in the leg and 75% (VAS 19.7 ± 20.8) in the low back. Eighty-six percent  of both leg pain and low back pain patients demonstrated a >= 50% reduction in pain at 90 days following implant. The comfort of the external wearable (Therapy Disc and Adhesive Clip) was rated 1.16 ± 1.53, on average, at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). All PROs demonstrated statistically significant symptomatic improvement at 90 days following implant of the micro-IPG., Limitations:   Limitations of this study include the lack of long-term results (beyond 90 days) and a relatively small sample size of 35 patients who were part of the analysis; additionally, there was no control arm or randomization as this was a single-arm study, without a comparator, designed to document the efficacy and safety of the device. Therefore, no direct comparisons to other SCS systems were possible., Conclusions: This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.

Background: Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming., Objectives: To determine if pain relief was related to technical factors of paresthesia, we measured and analyzed the paresthesia responses of patients successfully using HF10 therapy., Study Design: Prospective, multicenter, non-randomized, non-controlled interventional study., Setting: Outpatient pain clinic at 10 centers across the US and Italy., Methods: Patients with both back and leg pain already implanted with an HF10 therapy device for up to 24 months were included in this multicenter study. Patients provided pain scores prior to and after using HF10 therapy. Each patient's most efficacious HF10 therapy stimulation program was temporarily modified to a low frequency (LF; 60 Hz), wide pulse width (~470 mus), paresthesia-generating program. On a human body diagram, patients drew the locations of their chronic intractable pain and, with the modified program activated, all regions where they experienced LF paresthesia. Paresthesia and pain drawings were then analyzed to estimate the correlation of pain relief outcomes to overlap of pain by paresthesia, and the mediolateral distribution of paresthesia (as a surrogate of physiologic midline lead positioning)., Results: A total of 61 patients participated across 11 centers. Twenty-eight men and 33 women with a mean age of 56 ± 12 years of age participated in the study. The average duration of implantable pulse generator (IPG) implant was 19 ± 9 months. The average predominant pain score, as measured on a 0 - 10 visual analog scale (VAS), prior to HF10 therapy was 7.8 ± 1.3 and at time of testing was 2.5 ± 2.1, yielding an average pain relief of 70 ± 24%. For all patients, the mean paresthesia coverage of pain was 21 ± 28%, with 43% of patients having zero paresthesia coverage of pain. Analysis revealed no correlation between percentage of LF paresthesia overlap of predominant pain and HF10 therapy efficacy (P = 0.56). Exact mediolateral positioning of the stimulation electrodes was not found to be a statistically significant predictor of pain relief outcomes., Limitations: Non-randomized/non-controlled study design; short-term evaluation; certain technical factors not investigated., Conclusion: Both paresthesia concordance with pain and precise midline positioning of the stimulation contacts appear to be inconsequential technical factors for successful HF10 therapy application. These results suggest that HF10 therapy is not only paresthesia-free, but may be paresthesia-independent.