7 research outputs found
Objective wearable measures correlate with self-reported chronic pain levels in people with spinal cord stimulation systems
Abstract Spinal Cord Stimulation (SCS) is a well-established therapy for treating chronic pain. However, perceived treatment response to SCS therapy may vary among people with chronic pain due to diverse needs and backgrounds. Patient Reported Outcomes (PROs) from standard survey questions do not provide the full picture of what has happened to a patient since their last visit, and digital PROs require patients to visit an app or otherwise regularly engage with software. This study aims to assess the feasibility of using digital biomarkers collected from wearables during SCS treatment to predict pain and PRO outcomes. Twenty participants with chronic pain were recruited and implanted with SCS. During the six months of the study, activity and physiological metrics were collected and data from 15 participants was used to develop a machine learning pipeline to objectively predict pain levels and categories of PRO measures. The model reached an accuracy of 0.768 ± 0.012 in predicting the pain intensity of mild, moderate, and severe. Feature importance analysis showed that digital biomarkers from the smartwatch such as heart rate, heart rate variability, step count, and stand time can contribute to modeling different aspects of pain. The results of the study suggest that wearable biomarkers can be used to predict therapy outcomes in people with chronic pain, enabling continuous, real-time monitoring of patients during the use of implanted therapies
Comparing Fusion Rates Between Fresh-Frozen and Freeze-Dried Allografts in Anterior Cervical Discectomy and Fusion.
ObjectiveThe objective of this retrospective study is to compare the fusion rates in anterior cervical discectomy and fusion surgery using freeze-dried versus fresh-frozen allografts.MethodsThe study comprised 79 patients. Fifty-one patients received freeze-dried allograft (106 total spinal levels) and 28 patients received fresh-frozen allograft (50 total spinal levels). Fusion was assessed through trabecular bridging on follow-up anterior-posterior/lateral radiographs. Trabecular bridging was assessed on the superior and inferior borders of each spinal level and given a fusion grade. Complete fusion is defined as >50% bridging between superior and inferior borders of the bone graft; union is complete fusion in <26 weeks; delayed union is complete fusion after 26 weeks; and fibrous union is <50% bridging at ≥1 borders over 52 weeks.ResultsAll spinal levels reached complete fusion for both graft types. Of the freeze-dried treated cervical spinal levels, 77.35% (82/106) reached union (adequate trabecular bridging within 6 months) without delay compared with 80% (35/50) for the fresh-frozen bone graft group (P = 0.85). There was no significant difference in time-to-fusion analysis and no significant association between delayed union and any patient factors. In assessing Neck Disability Index (NDI), freeze-dried allografts did show a significantly greater decrease in NDI scores at 6 months (P = 0.03). At the 1 year follow-up, improvements in NDI were consistent in both allografts (P = 0.9647).ConclusionsFrom this study, freeze-dried and fresh-frozen allografts showed comparable rates of union, and both allografts can be used interchangeably for anterior cervical discectomy and fusion
Objective wearable measures and subjective questionnaires for predicting response to neurostimulation in people with chronic pain
Abstract Background Neurostimulation is an effective therapy for treating and management of refractory chronic pain. However, the complex nature of pain and infrequent in-clinic visits, determining subject’s long-term response to the therapy remains difficult. Frequent measurement of pain in this population can help with early diagnosis, disease progression monitoring, and evaluating long-term therapeutic efficacy. This paper compares the utilization of the common subjective patient-reported outcomes with objective measures captured through a wearable device for predicting the response to neurostimulation therapy. Method Data is from the ongoing international prospective post-market REALITY clinical study, which collects long-term patient-reported outcomes from 557 subjects implanted by Spinal Cord Stimulator (SCS) or Dorsal Root Ganglia (DRG) neurostimulators. The REALITY sub-study was designed for collecting additional wearables data on a subset of 20 participants implanted with SCS devices for up to six months post implantation. We first implemented a combination of dimensionality reduction algorithms and correlation analyses to explore the mathematical relationships between objective wearable data and subjective patient-reported outcomes. We then developed machine learning models to predict therapy outcome based on the subject’s response to the numerical rating scale (NRS) or patient global impression of change (PGIC). Results Principal component analysis showed that psychological aspects of pain were associated with heart rate variability, while movement-related measures were strongly associated with patient-reported outcomes related to physical function and social role participation. Our machine learning models using objective wearable data predicted PGIC and NRS outcomes with high accuracy without subjective data. The prediction accuracy was higher for PGIC compared with the NRS using subjective-only measures primarily driven by the patient satisfaction feature. Similarly, the PGIC questions reflect an overall change since the study onset and could be a better predictor of long-term neurostimulation therapy outcome. Conclusions The significance of this study is to introduce a novel use of wearable data collected from a subset of patients to capture multi-dimensional aspects of pain and compare the prediction power with the subjective data from a larger data set. The discovery of pain digital biomarkers could result in a better understanding of the patient’s response to therapy and their general well-being
The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for Surgical Technique for Spinal Cord Stimulation.
INTRODUCTION: The field of neurostimulation for the treatment of chronic pain is a rapidly developing area of medicine. Although neurostimulation therapies have advanced significantly as a result of technologic improvements, surgical planning, device placement, and postoperative care are of equal importance to optimize outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for these often-overlooked areas of neurostimulation practice.
MATERIALS AND METHODS: Authors were chosen based on their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from the last NACC publication in 2017 to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on evidence strength and consensus when evidence was scant.
RESULTS: This NACC project provides guidance on preoperative assessment, intraoperative techniques, and postoperative management in the form of consensus points with supportive evidence. These results are based on grade of evidence, strength of consensus, and expert opinion.
CONCLUSIONS: The NACC has given guidance for a surgical plan that encompasses the patient journey from the planning stage through the surgical experience and postoperative care. The overall recommendations are designed to improve efficacy and the safety of patients undergoing these neuromodulation procedures and are intended to apply throughout the international community
The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for surgical technique for spinal cord stimulation
Introduction: The field of neurostimulation for the treatment of chronic pain is a rapidly developing area of medicine. Although neurostimulation therapies have advanced significantly as a result of technologic improvements, surgical planning, device placement, and postoperative care are of equal importance to optimize outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for these often-overlooked areas of neurostimulation practice.
Materials and methods: Authors were chosen based on their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from the last NACC publication in 2017 to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on evidence strength and consensus when evidence was scant.
Results: This NACC project provides guidance on preoperative assessment, intraoperative techniques, and postoperative management in the form of consensus points with supportive evidence. These results are based on grade of evidence, strength of consensus, and expert opinion.
Conclusions: The NACC has given guidance for a surgical plan that encompasses the patient journey from the planning stage through the surgical experience and postoperative care. The overall recommendations are designed to improve efficacy and the safety of patients undergoing these neuromodulation procedures and are intended to apply throughout the international community