Catheter Tip-Associated Mass With Continuous Infusion of Sufentanil for Persistent Spinal Pain Syndrome Type 2: A Case Report Including Histopathologic Examination and Review of the Associated Basic and Clinical Research.

OBJECTIVES: Intrathecal opioids delivered by implanted pumps are used to treat malignant or nonmalignant chronic pain. In this study, we 1) review a case in which intrathecal infusions of sufentanil along with other adjuvants were used and after an extended period led to an intrathecal mass and 2) compared and contrasted the potential mechanisms for these phenomena. MATERIALS AND METHODS: A woman aged 66 years with a history of scoliosis and multiple spine surgeries was treated with an implantable drug delivery system for treating persistent pain after laminectomy. The patient received intrathecal medication comprising sufentanil, bupivacaine, and clonidine. RESULTS: Intrathecal therapy over approximately ten years served to reduce pain and improve function over the treatment period. After the extended treatment interval, the patient developed an intrathecal mass that was associated with impairment. The mass was surgically removed. Systematic histopathology revealed the space-occupying mass to largely comprise fibroblasts and some inflammatory cells embedded in a collagen mass located proximally to the catheter tip. CONCLUSIONS: To our knowledge, this is the first published case report of sufentanil causing this complication. The science and mechanism of intrathecal catheter tip-associated mass formation and associated clinical research correlates are reviewed in detail, and explanations for this phenomenon are proposed based on histochemical analysis of the patient's pathology findings.

Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial.

OBJECTIVE: This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. MATERIALS AND METHODS: This prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B (approximately 300-600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12-day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies. RESULTS: A total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non-serious device-related AE was reported, and no infections occurred during the extended trial. CONCLUSIONS: Multiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT03594266.

Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

BACKGROUND: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. OBJECTIVE: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. RESULTS: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. CONCLUSION: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354.

Higher Pain Sensitivity Predicts Efficacy of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Persons With Fibromyalgia: A Randomized Double-Blind Sham-Controlled Trial.

OBJECTIVES: This study investigated the efficacy of a transcutaneous electrical nerve stimulation (TENS) device (Quell®) for persons with symptoms due to fibromyalgia (FM). MATERIALS AND METHODS: One hundred nineteen (N = 119) subjects were randomly assigned to use an active (N = 62) or sham (N = 57) TENS for three months. All subjects completed baseline questionnaires and were administered quantitative sensory testing (QST). Subjects completed the Patients' Global Impression of Change (PGIC, primary outcome measure) and other mailed questionnaires (secondary outcome measures) at six weeks and three months. RESULTS: The subjects averaged 50.4 ± 13.5 years of age, 93.3% were female, and 79.8% were Caucasian. Most showed benefit from using the TENS, but no differences between groups were found on the primary outcome measure after three months (active 3.87 ± 1.85, sham 3.73 ± 1.80, 95% confidence interval [CI] [-0.60, 0.88], p = 0.707). Those with more hypersensitivity showed most improvement on the PGIC at six weeks (0.22, 95% CI [0.01, 0.43], p = 0.042) and three months (0.20, 95% CI [0.00, 0.41], p = 0.049) and among those with higher sensitivity based on QST, the active TENS group showed the most benefit with TENS compared with the sham treatment (1.20, 95% CI [0.22, 2.18], p = 0.017). No TENS-related serious adverse events were reported. Subjects in the sham group correctly identified their treatment 87.5% of the time, while, surprisingly, subjects in the active group correctly identified their treatment only 17.4% of the time. CONCLUSION: This study found no differences between those who were exposed to maximal-frequency active stimulation or minimal-frequency sham stimulation from a wearable TENS in reducing FM-related symptoms. However, those with greater hypersensitivity showed most benefit from TENS. Additional studies to help determine the role individual differences play in the use of TENS in managing FM-related symptoms are needed.

Clinical Integration of a Smartphone App for Patients With Chronic Pain: Retrospective Analysis of Predictors of Benefits and Patient Engagement Between Clinic Visits.

BACKGROUND: Although many pain-related smartphone apps exist, little attention has been given to understanding how these apps are used over time and what factors contribute to greater compliance and patient engagement. OBJECTIVE: This retrospective analysis was designed to help identify factors that predicted the benefits and future use of a smartphone pain app among patients with chronic pain. METHODS: An app designed for both Android and iOS devices was developed by Brigham and Women's Hospital Pain Management Center (BWH-PMC) for users with chronic pain to assess and monitor pain and communicate with their providers. The pain app offered chronic pain assessment, push notification reminders and communication, personalized goal setting, relaxation sound files, topics of interest with psychological and medical pain management strategies, and line graphs from daily assessments. BWH-PMC recruited 253 patients with chronic pain over time to use the pain app. All subjects completed baseline measures and were asked to record their progress every day using push notification daily assessments. After 3 months, participants completed follow-up questionnaires and answered satisfaction questions. We defined the number of completed daily assessments as a measure of patient engagement with the pain app. RESULTS: The average age of participants was 51.5 years (SD 13.7, range 18-92), 72.8% (182/253) were female, and 36.8% (78/212) reported the low back as their primary pain site. The number of daily assessments ranged from 1 to 426 (average 62.0, SD 49.9). The app was easy to introduce among patients, and it was well accepted. Those who completed more daily assessments (greater patient engagement) throughout the study were more likely to report higher pain intensity, more activity interference, and greater disability and were generally overweight compared with others. Patients with higher engagement with the app rated the app as offering greater benefit in coping with their pain and expressed more willingness to use the app in the future (P<.05) compared with patients showing lower engagement. Patients completing a small number of daily assessments reported less pain intensity, less daily activity interference, and less pain-related disability on average and were less likely to use the two-way messaging than those who were more engaged with the pain app (P<.05). CONCLUSIONS: Patients with chronic pain who appeared to manage their pain better were less likely to report benefits of a smartphone pain app designed for chronic pain management. They demonstrated lower patient engagement in reporting their daily progress, in part, owing to the perceived burden of regularly using an app without a perceived benefit. An intrinsically different pain app designed and targeted for individuals based on early identification of user characteristics and adapted for each individual would likely improve compliance and app-related patient engagement.

Outcome of a High-Frequency Transcutaneous Electrical Nerve Stimulator (hfTENS) Device for Low Back Pain: A Randomized Controlled Trial.

OBJECTIVE: This controlled trial examined the benefit of a high-frequency transcutaneous electrical nerve stimulation (hfTENS) device (the Quell, NeuroMetrix, Inc., Waltham, MA, U.S.A.) for patients with chronic low back pain (CLBP). METHODS: Thirty-five (n = 35) participants were randomly assigned to use the device each day for 3 months (experimental group) and were compared with 33 subjects without the device (treatment-as-usual control group). All patients were instructed to complete baseline questionnaires and were assessed on thresholds of pressure pain and mechanical temporal summation as part of standardized quantitative sensory testing (QST). The subjects also uploaded smartphone applications (apps) for tracking use of the hfTENS and for daily pain assessment. Each participant completed weekly phone interviews, was prompted to complete daily pain app assessments, and was asked to repeat the baseline questionnaires again after 6 weeks and 3 months. RESULTS: Sixty percent of the subjects were female, 77.9% were Caucasian, and the average age was 46.2 years. Significant reductions in pain intensity (P < 0.01) and activity interference (P < 0.025) and significant improvements in pain catastrophizing (P < 0.025) were noted in the experimental group compared with the control group. No group differences were found on depression, anxiety, or pain-related disability. Older subjects with a longer duration of pain tended to use the hfTENS more often. Subjects who showed greater sensitivity based on QST results revealed increased use of the hfTENS (P < 0.025) and tended to believe that the hfTENS was more helpful in reducing their back pain, but these findings did not reach significance (P = 0.09). CONCLUSION: These results suggest that hfTENS can have a moderate effect in reducing pain and improving quality of life in low back pain patients. Further trials designed to determine the mechanism of action of the hfTENS are needed.

Efficacy of Vibrating Gloves for Chronic Hand Pain due to Osteoarthritis.

Objective: This study investigated the efficacy of vibration technology for women with hand pain due to osteoarthritis (OA) to see if mild compression and small vibrating motors were beneficial with periodic use. Methods: Sixty-nine (N = 69) women with OA hand pain were randomized into two groups, one that used vibrating gloves once a day for 20 minutes (Experimental, N = 34) and one that was monitored for three months without gloves (Control, N = 35). All subjects completed baseline questionnaires, were administered mechanical quantitative sensory testing (QST), and uploaded a smartphone pain app for daily assessment. Patients were included if they had chronic pain for more than three months, reported a 4 or higher on a 0-10 pain intensity scale, and could speak and understand English. Results: In general, compared with the control subjects, those in the experimental condition demonstrated reduced pain intensity (P < 0.05) after using the vibrating gloves. No differences were found between groups on activity interference, mood, or sleep. No differences were also noted based on age, pain duration, hand dominance, weight, body mass index, or hours sleeping. Those with greater sensitivity on QST demonstrated more disability, emotional distress, and pain catastrophizing (P < 0.05) but no differences in pain relief from or satisfaction with the vibrating gloves. Discussion: Overall, the results demonstrated that the vibrating gloves were moderately helpful in reducing hand pain in women with OA (53.5%), and most expressed willingness to use the gloves (71.4%) and use the pain app (55.8%) in the future. Additional studies to determine the mechanism of action of the gloves in managing pain would be recommended.

Unique Intradural Inflammatory Mass Containing Precipitated Morphine: Confirmatory Analysis by LESA-MS and MALDI-MS.

Opioids are often used for analgesia via continuous intrathecal delivery by implantable devices. A higher concentration and daily dose of opioid have been postulated as risk factors for intrathecal granuloma formation. We present a 42-year-old female patient with chronic abdominal pain from refractory pancreatitis, with an intrathecal drug delivery device implanted 21 years prior, delivering continuous intrathecal morphine. After many years without concerning physical signs or complaints, with gradual increases in daily morphine dose, she presented with rapidly progressive neurologic deficits, including lower extremity, bladder, and bowel symptoms. These symptoms were determined to be secondary to mass effect and local inflammation related to an intrathecal catheter tip granuloma, detected on magnetic resonance imaging of the spine. The mass was urgently resected. On histopathologic examination, this granuloma was found to be unique, in that in addition to the expected inflammatory components, it appeared to contain precipitated nonpolarizable crystals. These were identified as precipitated morphine using liquid extraction surface analysis-tandem mass spectrometry (LESA-MS/MS) and matrix-assisted laser desorption ionization-Fourier transform ion cyclotron resonance-mass spectrometry imaging (MALDI-FTICR-MSI). In addition to the unique finding of precipitated morphine crystals, the long-term follow-up of both morphine concentration and daily dose increases provides insight into the formation of intrathecal granulomas.

Attitudes of Primary Care Practitioners in Managing Chronic Pain Patients Prescribed Opioids for Pain: A Prospective Longitudinal Controlled Trial.

OBJECTIVE: There is increasing concern among primary care practitioners (PCPs) regarding medication misuse and noncompliance among chronic pain patients prescribed opioids for pain. This study investigated the benefits of interventions designed to track potential opioid misuse and to improve practitioner confidence in managing patients with chronic pain through the use of risk assessment, monthly monitoring of compliance, and specialty support. METHODS: Fifty-six PCPs and 253 chronic pain patients were recruited into the study. All patients were assessed for risk and called once a month for 6 months to monitor pain and opioid compliance. Practitioner knowledge about opioids, concerns about analgesic prescriptions, practice behavior, and attitudes of managing chronic pain patients were assessed and questionnaires were repeated after 1 year. Practitioners in the experimental group received monthly patient summary reports that consisted of pain, mood, activity levels, healthcare utilization, and results of the Opioid Compliance Checklist, while practitioners in the control group did not receive the monthly reports. RESULTS: After 1 year all the PCPs reported improvement in identifying patients at risk for misuse (P < 0.05), perceived confidence in prescribing opioids for pain (P < 0.05) and increased satisfaction with communication with pain specialists (P < 0.05). The patients reported greater compliance with their opioid medication and felt that the monthly monitoring was beneficial. Despite modest improvements, many PCPs still lacked confidence in managing pain patients and reported reluctance to prescribe opioids for chronic noncancer pain, especially among younger practitioners. This study demonstrates the benefits of careful monitoring of chronic pain patients and need for pain management support within primary care.

Chronic Pain, Comorbid Medical Conditions, and Associated Risk Factors in Kuwait: Gender and Nationality Differences.

OBJECTIVE: Chronic pain is an international health problem that imposes enormous costs on societies around the world. There is good reason to suspect that chronic pain is a serious health issue in Kuwait and is associated with comorbid medical conditions like diabetes. The aim of this study is to examine the report of pain and incidence of medical comorbidities among a large convenience sample of patients treated at a private rehabilitation center in Kuwait and to examine differences in patient groups based on age, gender, and Kuwaiti nationality. METHODS: This study examined intake data from 2,103 patients treated at a rehabilitation center in Kuwait. Most of the subjects were female (55.4%) and averaged 43.3 years of age (±14.5, range 18-88). Sixty nine percent were Kuwaiti citizens and 57.9% were employed. RESULTS: Marked differences in pain and health-related conditions were found between Kuwaiti nationals and non-Kuwaitis, with significantly increased incidences of hypertension, osteoarthritis, diabetes, asthma, osteoporosis, and cardiac and respiratory problems among the Kuwaitis (P < 0.001). Notable gender differences were also identified with women reporting more intense, widespread pain, and reporting more comorbid medical problems compared with men (P < 0.001). CONCLUSIONS: This extensive survey study that found female Kuwaitis to have a higher incidence of pain and medical comorbidities than males and non-Kuwaitis highlights the role of cultural factors in contributing to pain and comorbid medical conditions. This information is critical in organizing resources to implement adequate healthcare services and behavioral interventions in Kuwait and other Arab countries to improve pain and health-related conditions.

The clinical impact of a false-positive urine cocaine screening result on a patient's pain management.

BACKGROUND: The urine of a patient admitted for chest and epigastric pain tested positive for cocaine using an immunoassay-based drug screening method (positive/negative cutoff concentration 150 ng/mL). Despite the patient's denial of recent cocaine use, this positive cocaine screening result in conjunction with a remote history of drug misuse impacted the patient's recommended pain therapy. Specifically, these factors prompted the clinical team to question the appropriateness of opioids and other potentially addictive therapeutics during the treatment of cancer pain from previously undetected advanced pancreatic carcinoma. OBJECTIVE: After pain management and clinical pathology consultation, it was decided that the positive cocaine screening result should be confirmed by gas chromatography-mass spectrometry (GC-MS) testing. RESULTS: This more sensitive and specific analytical technique revealed that both cocaine and its primary metabolite benzoylecgonine were undetectable (i.e., less than the assay detection limit of 50 ng/mL), thus indicating that the positive urine screening result was falsely positive. With this confirmation, the pain management service team was reassured in offering intrathecal pump (ITP) therapy for pain control. ITP implantation was well tolerated, and the patient eventually achieved excellent pain relief. However, ITP therapy most likely would not have been utilized without the GC-MS confirmation testing unless alternative options failed and extensive vigilant monitoring was initiated. CONCLUSION: As exemplified in this case, confirmatory drug testing should be performed on specimens with unexpected immunoassay-based drug screening results. To our knowledge, this is the first report of a false-positive urine cocaine screening result and its impact on patient management.

Neuromodulation for intractable headaches.

Intractable chronic headaches are a major challenge for both patients and healthcare professionals. Over the last two decades, implantable electrical neuromodulators, previously established to manage other forms of chronic pain, have been used increasingly for intractable primary and secondary headache disorders. We review the current approaches to the management of refractory headaches using neuromodulation. Indications, operative considerations and complications are discussed based on our experience and a review of the literature. The field of neuromodulation has been rapidly advancing, with many new targets being discovered and novel devices being developed for treating craniofacial pain. We discuss some of these targets, detailing the latest advances in the area of neuromodulation for intractable headaches.

Improving patient experience with spinal cord stimulation: implications of position-related changes in neurostimulation.

OBJECTIVES: The objective of this narrative review is to discuss the clinical implications of position-related changes in spinal cord stimulation and technological improvements to better meet patient needs. METHODS: Keywords applicable to spinal cord stimulation therapy, including paresthesia perception, spinal cord position, lead impedance, and sensor technologies, were searched in the PubMed, EMBASE, and Cochrane Library databases. Literature analysis, combined with extensive clinical experience with spinal cord stimulation therapy, forms the basis of this review. RESULTS: Fluctuations in paresthesia perception are largely caused by variation in the distance between the fixed electrodes and the spinal cord consequent to patient movement. Patients employ multiple strategies with varying success to manage position-related fluctuations in stimulation perception, which may result in suboptimum therapy delivery. CONCLUSIONS: A new type of spinal cord stimulation system that incorporates accelerometer technology to automatically adjust stimulation amplitude based on patient position may better meet patient analgesic needs and is in early clinical application.

Relationship between self-reported low-back pain severity and other patient-reported outcomes: results from an observational study.

STUDY DESIGN: A cross-sectional observational study of physicians and patients with chronic low-back pain (CLBP) in the United States. OBJECTIVE: To evaluate the association of patient-reported CLBP severity with other patient-reported outcomes. SUMMARY OF BACKGROUND DATA: Appropriate management of patients with CLBP can be enhanced by understanding how patients perceive the severity of their CLBP. METHODS: Data were from the 2009 Adelphi Disease Specific Programme. Patients reported the severity of their CLBP condition by answering the question Please rate how your chronic lower back pain condition is today with responses of mild, moderate, and severe. Patient-reported severity was evaluated with respect to scores on standard patient self-report measures of pain, pain interference, health status, functional disability, work productivity, and questions addressing satisfaction with medications for treating CLBP. RESULTS: Of 1860 subjects in the CLBP database, 1363 (73.3%) agreed to complete the survey. This sample was similarly distributed between males (49%) and females (51%), with mean age 54.8 years: 52% were employed at least part-time. CLBP severity was rated as mild, moderate and severe by 28.6%, 53.3%, and 18.2% of patients, respectively. With increasing CLBP severity, significant differences were observed in increased pain (P<0.0001), pain interference with function (P<0.0001), and impairment while working due to CLBP (P<0.01), mainly due to presenteeism. Increased work impairment resulted in higher costs related to lost work productivity; annual lost productivity costs were estimated at $7080, $16,616, and $25,032 per patient for mild, moderate, and severe CLBP, respectively (P<0.0001 for pairwise comparisons). Patient satisfaction with pain-related medication was inversely associated with CLBP severity. CONCLUSIONS: The association between patient-reported CLBP severity and other patient-reported outcomes demonstrates that in the clinical setting, patient-reported CLBP severity provides an accurate and suitable indicator of patient-reported health status. This indicator may be useful for guiding management strategies for CLBP patients.

Relationship of negative affect and outcome of an opioid therapy trial among low back pain patients.

OBJECTIVES: Patients with chronic noncancer pain frequently report symptoms of depression and anxiety (negative affect), which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy. The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment-related outcomes in a double-blind, placebo-controlled study of extended-release (ER) hydromorphone among opioid-tolerant patients with chronic low back pain. METHODS: Four hundred fifty-nine (N = 459) patients participated in the titration/conversion phase of a multicenter study, of which 268 were randomized to receive once-daily hydromorphone or placebo. All patients completed the Hospital Anxiety and Depression Scale (HADS) at baseline and were divided evenly into Low (N = 157), Moderate (N = 155), and High (N = 147) negative affect groups based on their scores. Group differences in numerical pain intensity measures at home and in the clinic, Roland-Morris Disability ratings, and measures of symptoms from the Subjective Opiate Withdrawal Scale (SOWS) throughout the trial were analyzed. RESULTS: Two hundred sixty-eight of the initial 459 subjects who entered the 2 to 4-week titration/conversion phase (pretreatment) were successfully randomized to either placebo or ER hydromorphone; a total of 110 patients then completed this double-blind phase of the study. Those in the Moderate and High negative affect groups tended to drop out more often during the titration/conversion phase because of the adverse effects or lack of efficacy of their prescribed opioid than those in the Low negative mood group (P < 0.05). Overall, those patients in the Moderate and High groups reported significantly higher pain intensity scores in at-home and in-clinic pain intensity ratings (P < 0.05), greater disability on the Roland-Morris Scale (P < 0.01), and more withdrawal symptoms on the SOWS (P < 0.05) than those in the Low group. Higher negative affect scores also predicted less favorable ratings of the study drug during the titration phase (P < 0.05). Interestingly, the High negative affect group showed the most improvement in pain in the placebo condition (P < 0.05). CONCLUSIONS: Negative affect is associated with diminished benefit during a trial of opioid therapy and is predictive of dropout in a controlled clinical trial.

Optimizing an mHealth Program to Promote Type 2 Diabetes Prevention in High-Risk Individuals: Cross-Sectional Questionnaire Study.

BACKGROUND: We evaluated the outcomes of a pilot SMS text messaging-based public health campaign that identified social networking nodes and variations of response rates to develop a list of variables that could be used to analyze and develop an outreach strategy that would maximize the impact of future public health campaigns planned for Kuwait. Computational analysis of connections has been used to analyze the spread of infectious diseases, dissemination of new thoughts and ideas, efficiency of logistics networks, and even public health care campaigns. Percolation theory network analysis provides a mathematical alternative to more established heuristic approaches that have been used to optimize network development. We report on a pilot study designed to identify and treat subjects at high risk of developing type 2 diabetes mellitus in Kuwait. OBJECTIVE: The aim of this study was to identify ways to optimize efficient deployment of resources and improve response rates in a public health campaign by using variables identified in this secondary analysis of our previously published data (Alqabandi et al, 2020). This analysis identified key variables that could be used in a computational analysis to plan for future public health campaigns. METHODS: SMS text message screening posts were sent inviting recipients to answer 6 questions to determine their risk of developing type 2 diabetes mellitus. If subjects agreed to participate, a link to the Centers for Disease Control and Prevention prediabetes screening test was automatically transmitted to their mobile devices. The phone numbers used in this campaign were recorded and compared to the responses received through SMS text messaging and social media forwarding. RESULTS: A total of 180,000 SMS text messages through 5 different campaigns were sent to 6% of the adult population in Kuwait. A total of 260 individuals agreed to participate, of which 153 (58.8%) completed the screening. Remarkably, 367 additional surveys were received from individuals who were not invited by the original circulated SMS text messages. These individuals were invited through forwarded surveys from the original recipients after authentication with the study center. The original SMS text messages were found to successfully identify influencers in existing social networks to improve the efficacy of the public health campaign. CONCLUSIONS: SMS text messaging-based health care screening campaigns were found to have limited effectiveness alone; however, the increased reach through shared second-party forwarding suggests the potential of exponentially expanding the reach of the study and identifying a higher percentage of eligible candidates through the use of percolation theory. Future research should be directed toward designing SMS text messaging campaigns that support a combination of SMS text message invitations and social networks along with identification of influential nodes and key variables, which are likely unique to the environment and cultural background of the population, using percolation theory modeling and chatbots.

Race differences in pain and pain-related risk factors among former professional American-style football players.

ABSTRACT: The burden of pain is unequal across demographic groups, with broad and persisting race differences in pain-related outcomes in the United States. Members of racial and ethnic minorities frequently report more pervasive and severe pain compared with those in the majority, with at least some disparity attributable to differences in socioeconomic status. Whether race disparities in pain-related health outcomes exist among former professional football players is unknown. We examined the association of race with pain outcomes among 3995 former professional American-style football players who self-identified as either Black or White. Black players reported more intense pain and higher levels of pain interference relative to White players, even after controlling for age, football history, comorbidities, and psychosocial factors. Race moderated associations between several biopsychosocial factors and pain; higher body mass index was associated with more pain among White but not among Black players. Fatigue and psychosocial factors were more strongly related to pain among Black players relative to White players. Collectively, the substantial social and economic advantages of working as a professional athlete did not seem to erase race-related disparities in pain. We highlight an increased burden of pain among elite Black professional football players and identify race-specific patterns of association between pain and biopsychosocial pain risk factors. These findings illuminate potential future targets of interventions that may serve to reduce persistent disparities in the experience and impact of pain.