Retention, adherence, and acceptability testing of a digital health intervention in a 3-group randomized controlled trial for chronic musculoskeletal pain.

OBJECTIVES: Evaluate a digital health intervention using Auricular Point Acupressure (APA) for chronic musculoskeletal pain in terms of participant retention, adherence, acceptability, and satisfaction. Chronic musculoskeletal pain is a global concern and there are persistent challenges in pain management. Despite the value of digital health interventions, these interventions need to be fully evaluated for feasibility. METHODS: We conducted a 3-group, longitudinal, randomized controlled trial (RCT). After Institutional Review Board approval, we posted recruitment flyers in a university, healthcare clinics, and community settings. Participants were randomized into an in-person + app group (n = 8), virtual + app group (n = 7), and a wait-list, education-enhanced control group (n = 8), evaluating our outcomes using standard feasibility measures. The 4-week intervention consisted of virtual sessions, telecommunications, and our APA app, followed by a 3-month follow-up. RESULTS: Data from 22 participants were subsequently analyzed (95.7%). All app participants adhered to the study protocol and used APA at the minimum recommended frequency and duration. The virtual + app group used APA more during the intervention and follow-up periods. All app participants found the intervention to be acceptable and at least 80% overall were satisfied with APA at the 3-month follow-up. There were no adverse events reported. CONCLUSIONS: Our digital health intervention was found to be acceptable and sustainable; participants adhered to and were satisfied with the intervention providing support for a larger RCT. CLINICAL TRIAL: #: NCT05020470.

Exploring the Feasibility of Virtually Delivered Auricular Point Acupressure in Self-Managing Chronic Pain: Qualitative Study.

Background: Chronic pain remains highly prevalent. Current pharmacological and non-pharmacological strategies have not adequately managed chronic pain which has contributed to disability and high healthcare costs. With existing challenges in providing adequate pain care and access, we tested vAPA, a virtually delivered, self-management intervention using Auricular Point Acupressure (APA) by mobile app and virtual consultations (telehealth). Our key purpose was to evaluate the feasibility of the vAPA in self-managing chronic pain in preparation for a future randomized controlled trial. Methods: We conducted a descriptive, qualitative study evaluating our 4-week vAPA intervention among 18 participants. We used directed qualitative content analysis. Results and Conclusion. Participants perceived that vAPA was feasible (acceptable, useable, practical, and beneficial). In addition, the following themes were gathered: better control of pain, less use of pain medications, self-management and motivation in pain, and expectations for pain relief. Refinements were recommended for the app, content, and delivery to improve study interventions. Findings are relevant in moving forward to a future randomized controlled trial and for wider implementation in a pragmatic clinical trial.

Evaluating Auricular Point Acupressure for Chronic Low Back Pain Self-Management Using Technology: A Feasibility Study.

BACKGROUND: Chronic low back pain, one of the most common reasons for seeking healthcare services, causes significant negative impacts on individuals and society. Nonpharmacologic therapies and self-management are included in practice guidelines, but their implementation is challenging. AIM: To assess the feasibility of using an auricular point acupressure (APA) mobile app as a self-guided tool to learn and self-administer APA to manage chronic low back pain (cLBP) and to compare cLBP outcomes between 2 groups (app vs app + telehealth). DESIGN: A 2-phase study design was used. In phase 1, participants (app group, n = 18) had in-person study visits and installed the app to learn and self-administer APA to manage cLBP. In phase 2, all research activities occurred remotely due to the COVID-19 pandemic, so a second group was recruited (app + telehealth, n = 19). The app + telehealth group underwent a virtual session, installed the app, and were provided the opportunity for questions and verification on the accuracy of the self-administered APA. SETTING: The participants were recruited by distributing study flyers at outpatient clinics and referrals. PARTICIPANTS: Participants with chronic low back pain were eliglbe for the study. METHODS: Using a quasi-experimental design with a mixed methods approach, all participants were instructed to download the APA app, provided an APA kit (includes seeds embedded within pre-cut squares of adhesive tape), and advised to self-administer APA with guidance from the app for 4 weeks to manage their cLBP. Study outcomes were collected at the preintervention time point as well as postintervention and 1-month follow-up. Interviews were also conducted at the postintervention time point. RESULTS: Of the 37 participants enrolled, six dropped out, and the attrition rate was 16%. Adherence to APA practice was high (85%-94%). After 4 weeks of APA treatment, participants in the app + telehealth group experienced a 29% decrease in pain intensity during the postintervention time point and a 35% reduction during the 1-month follow-up. Similar improvements were noted in pain interference (28%) and physical function (39%) for participants in the app + telehealth group at the 1-month follow-up. These changes are slightly higher compared with those in the app group (21% pain intensity reduction, 23% improved pain interferences, and 26% improved physical function) during the 1-month follow-up. Overall, APA was found to be feasible using the app and the qualitative findings showed acceptability of the intervention in both groups. CONCLUSIONS: It is feasible to learn and self-administer APA with an app, supplemented with either in-person or telehealth sessions, presenting a promising intervention toward cLBP self-management. Telehealth was found to boost this intervention effectively.

Peripheral Nerve Stimulation in Pain Management: A Systematic Review.

BACKGROUND: Peripheral nerve stimulation (PNS) has been increasingly used to manage acute and chronic pain. However, the level of clinical evidence to support its use is not clear. OBJECTIVES: To assess the clinical evidence of PNS in the treatment of acute or chronic pain. STUDY DESIGN: A systematic review of the efficacy and safety of PNS in managing acute or chronic pain. METHODS: Data sources were PubMed, Cochrane Library, Scopus, CINAHL Plus, Google Scholar, and reference lists. The literature search was performed up to December 2019. Study selection included randomized trials, observational studies, and case reports of PNS in acute or chronic pain. Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR). The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. Data syntheses: 227 studies met inclusion criteria and were included in qualitative synthesis. RESULTS: Evidence synthesis based on randomized controlled trials (RCTs) and observational studies showed Level I and II evidence of PNS in chronic migraine headache; Level II evidence in cluster headache, postamputation pain, chronic pelvic pain, chronic low back and lower extremity pain; and Level IV evidence in peripheral neuropathic pain, and postsurgical pain. Peripheral field stimulation has Level II evidence in chronic low back pain, and Level IV evidence in cranial pain. LIMITATIONS: Lack of high-quality RCTs. Meta-analysis was not possible due to wide variations in experimental design, research protocol, and heterogeneity of study population. CONCLUSIONS: The findings of this systematic review suggest that PNS may be effective in managing chronic headaches, postamputation pain, chronic pelvic pain, and chronic low back and lower extremity pain, with variable levels of evidence in favor of this technique.

Auricular Point Acupressure Smartphone Application to Manage Chronic Musculoskeletal Pain: A Longitudinal, One-Group, Open Pilot Trial.

BACKGROUND: Chronic musculoskeletal pain (CMP) is the most common self-reported chronic pain condition. Current treatment for CMP is limited. METHODS: This was a two-phase study. In Phase 1, three auricular point acupressure (APA)-naïve participants were recruited to explore their experiences of APA and a smartphone app was developed based on their feedback. In Phase 2, a prospective longitudinal study was used to examine the effectiveness of the smartphone app to self-manage CMP. RESULTS: Phase 1 resulted in the successful development of the APA smartphone app. In Phase 2, after four weeks of APA, participants reported reduced pain intensity (30%), pain interference (35%), and disability (40%), as well as improved physical function (47%). The mean score for the participants' perception of treatment efficacy was 4.94 (SD = 2.08, scale of 0-7) indicating that approximately 70% of participants rated global improvements with noticeable changes. The majority (88%, n = 22) of the participants were satisfied with the treatment: 32% [8] were very satisfied and 56% [n = 14] were somewhat satisfied. The average frequency of pressing APA seeds per day was 2.93 times (SD = 2.27, range 0-10) and 1.60 minutes per time (SD = 2.64, range 0-10); the participants were able to adhere to the suggested pressing time per day, although they only pressed the ear points about 53% of the suggested time. CONCLUSION: It is feasible for individuals to learn APA from the smartphone app and successfully self-administer APA to manage their pain. Participants found the app useful and were satisfied with the information provided through the app.

Treatment of Déjerine-Roussy syndrome pain with scrambler therapy.

Aim: Déjerine-Roussy syndrome or central thalamic pain can be devastating, and treatment with drugs and even deep brain stimulation can be unsatisfactory. Scrambler therapy is a form of neuromodulation that uses external skin electrodes to send a 'non-pain' signal to the brain, with some success in difficult-to-treat syndromes such as neuromyelitis optica spectrum disorder. We used scrambler therapy to treat a patient with 6 years of disabling Déjerine-Roussy syndrome pain. Methods: A 56-year-old man received multiple daily then monthly treatments with electrode pairs placed just above the area of distal pain. Each treatment was for 40 min. Results: His allodynia and hyperalgesia resolved within 10 min, and his pain score fell to almost zero after 30 min. Months later, he resumed normal activity and is off all his pain medications. No side effects were noted. Conclusion: Scrambler therapy appeared to reverse 6 years of disabling pain safely and economically, and continues to be effective. Further multi-institutional trials are warranted for this rare syndrome.

A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol.

BACKGROUND: Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment. METHODS/DESIGN: For this prospective randomized controlled study, participants will be randomly assigned to three groups: (1) APA group (active points related to cLBP), (2) Comparison group-1 (non-active points, unrelated to cLBP), and (3) Comparison group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly telephone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post APA treatment, and follow-up study visits at 1, 3, 6, 9 and 12 months post completion of treatment for a total of seven assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels. DISCUSSION: This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03589703. Registered on 22 May 2018.

The Neuromodulation Appropriateness Consensus Committee on Best Practices for Dorsal Root Ganglion Stimulation.

INTRODUCTION: The Neuromodulation Appropriateness Consensus Committee (NACC) is dedicated to improving the safety and efficacy of neuromodulation and thus improving the lives of patients undergoing neuromodulation therapies. With continued innovations in neuromodulation comes the need for evolving reviews of best practices. Dorsal root ganglion (DRG) stimulation has significantly improved the treatment of complex regional pain syndrome (CRPS), among other conditions. Through funding and organizational leadership by the International Neuromodulation Society (INS), the NACC reconvened to develop the best practices consensus document for the selection, implantation and use of DRG stimulation for the treatment of chronic pain syndromes. METHODS: The NACC performed a comprehensive literature search of articles about DRG published from 1995 through June, 2017. A total of 2538 article abstracts were then reviewed, and selected articles graded for strength of evidence based on scoring criteria established by the US Preventive Services Task Force. Graded evidence was considered along with clinical experience to create the best practices consensus and recommendations. RESULTS: The NACC achieved consensus based on peer-reviewed literature and experience to create consensus points to improve patient selection, guide surgical methods, improve post-operative care, and make recommendations for management of patients treated with DRG stimulation. CONCLUSION: The NACC recommendations are intended to improve patient care in the use of this evolving therapy for chronic pain. Clinicians who choose to follow these recommendations may improve outcomes.

Spinal Cord Stimulation for Treating Chronic Pain: Reviewing Preclinical and Clinical Data on Paresthesia-Free High-Frequency Therapy.

BACKGROUND: Traditional spinal cord stimulation (SCS) requires that paresthesia overlaps chronic painful areas. However, the new paradigm high-frequency SCS (HF-SCS) does not rely on paresthesia. STUDY DESIGN: A review of preclinical and clinical studies regarding the use of paresthesia-free HF-SCS for various chronic pain states. METHODS: We reviewed available literatures on HF-SCS, including Nevro's paresthesia-free ultra high-frequency 10 kHz therapy (HF10-SCS). Data sources included relevant literature identified through searches of PubMed, MEDLINE/OVID, and SCOPUS, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary goal is to describe the present developing conceptions of preclinical mechanisms of HF-SCS and to review clinical efficacy on paresthesia-free HF10-SCS for various chronic pain states. RESULTS: HF10-SCS offers a novel pain reduction tool without paresthesia for failed back surgery syndrome and chronic axial back pain. Preclinical findings indicate that potential mechanisms of action for paresthesia-free HF-SCS differ from those of traditional SCS. CONCLUSIONS: To fully understand and utilize paresthesia-free HF-SCS, mechanistic study and translational research will be very important, with increasing collaboration between basic science and clinical communities to design better trials and optimize the therapy based on mechanistic findings from effective preclinical models and approaches. Future research in these vital areas may include preclinical and clinical components conducted in parallel to optimize the potential of this technology.

Review of Recent Advances in Peripheral Nerve Stimulation (PNS).

Peripheral nerve stimulation (PNS) for the treatment of chronic pain has become an increasingly important field in the arena of neuromodulation, given the ongoing advances in electrical neuromodulation technology since 1999 permitting minimally invasive approaches using an percutaneous approach as opposed to implantable systems. Our review aims to provide clinicians with the recent advances and studies in the field, with specific emphasis on clinical data and indications that have been accumulated over the last several years. In addition, we aim to address key basic science studies to further emphasize the importance of translational research outcomes driving clinical management.

Complementary and alternative treatments for chronic pelvic pain.

Chronic pelvic pain (CPP) is a significant clinical entity that affects both men and women alike. The etiologies of CPP are multifactorial, and treatments are myriad. Complementary and Alternative Medicine (CAM) refers to non-allopathic health systems, and its use is popular in the United States. In particular, several recent studies have investigated the efficacy of various CAM practices in the treatment of CPP. The authors systematically evaluated recent literature in this area by searching the PubMed database for English-language studies published between January 2007 and August 2012.

Cephalad lead migration following spinal cord stimulation implantation.

Lead migration (LM) is the most common complication after spinal cord stimulation (SCS). Although multiple reports of caudad LM have been described, cephalad LM has not been reported. Here we describe a case in which a stimulator lead migrates in the cephalad direction. A 60-year-old male with failed back surgery syndrome underwent SCS lead implantation via a dual lead approach to the top of vertebral body (VB) T9. A standard strain relief loop was used for each lead in the paramedian pocket. Postoperative testing revealed 100% paresthesia coverage of the painful areas. For the first 4 days, the patient continued to have excellent coverage; however, by the seventh day, the paresthesias ascended to above the nipple line. At the 2-week follow-up, cephalad migration of the left lead to the top of VB T1 was confirmed on fluoroscopy. The patient underwent successful lead revision in which a single paramedian incision technique was used to place extra sutures and a "figure-of-eight" strain relief loop. We provide the first case report of significant cephalad LM following SCS lead implantation. This migration can occur despite the use of current standard anchoring techniques. Additional investigation into the mechanism of such LM and lead-securing techniques is warranted.

Spinal cord stimulators: typical positioning and postsurgical complications.

OBJECTIVE: Implantation of a spinal cord stimulator (SCS) is one option for pain control in individuals with chronic lumbosacral radicular or axial lumbar pain. The expected positioning of SCSs based on the location of pain, the types of electrodes (percutaneous vs surgical paddle), and the types of electrode arrays and the potential complications have not been described to date in the radiology literature. MATERIALS AND METHODS: A 5-year retrospective review of the radiology information system at our institution revealed 24 patients with images of 36 SCSs. Those images were reviewed to identify the location and type of electrodes as well as the location of the lead within the spinal canal. Not all implantable pulse generators were within the radiologic field of view. Complications identified by reviewing medical records were correlated with imaging findings. RESULTS: Fourteen different types of electrodes were identified. Most were placed in the thoracic spine only, but six thoracolumbar and two cervical spine electrodes were also present. We measured the position of the electrodes within the spinal canal on 26 CT studies of the 24 patients. On 22 of 26 CT studies, the electrodes were placed in the epidural space in the posterior one third of the spinal canal. Complications included misplaced, retained, and broken leads; puncture of the thecal sac; infection; and hematoma. CONCLUSION: Radiologists should be familiar with the different types of electrodes and typical spinal locations of electrodes, leads, and implantable pulse generators. Improper placement of electrodes may lead to ineffective pain relief or to other complications.

Effective treatments for pain in the older patient.

By 2050, the number of older persons across the globe will exceed the number of younger people for the first time in history. Chronic conditions, especially pain, will rise in prevalence as the population ages. Controlling pain in this unique subset of the population demands careful attention to pharmacokinetic and pharmacodynamic factors and their specific impact on pharmacotherapies, relevant complementary and alternative medicine therapies, and interventional strategies.

Pain management in trauma patients.

Trauma is a major cause of mortality throughout the world. In recent years, major advances have been made in the management of trauma, the end result of which has been reduced mortality and enhanced function. One of these areas is pain control. Improved pain management has not only led to increased comfort in trauma patients, but has also been shown to reduce morbidity and improve long-term outcomes. This review focuses on the treatment of pain in the setting of acute injury and on pain management in trauma patients who go on to develop chronic pain. Emphasis is placed on pharmacologic interventions, invasive and noninvasive pain management techniques, analgesia in challenging patients, and pain control in commonly encountered trauma conditions.