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.

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.

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.

Effects of Wearable Transcutaneous Electrical Nerve Stimulation on Fibromyalgia: A Randomized Controlled Trial.

PURPOSE: Fibromyalgia is a chronic condition characterized by widespread pain and interference with daily activities. The aim of this study is to assess the benefit of transcutaneous electrical nerve stimulation (TENS) for persons diagnosed with fibromyalgia. PATIENTS AND METHODS: Adults meeting diagnostic criteria for fibromyalgia were randomized in a double-blind trial to receive either an active (n=62) or sham (n=57) wearable TENS device for 3-months. Subjects were classified as having lower or higher pain sensitivity by Quantitative Sensory Testing (QST). Patient Global Impression of Change (PGIC, primary outcome) and secondary efficacy measures including Fibromyalgia Impact Questionnaire (FIQR), Brief Pain Inventory (BPI) and painDETECT questionnaire (PDQ) were assessed at baseline, 6-weeks and 3-months. Treatment effects were determined by a mixed model for repeated measures (MMRM) analysis of the intention-to-treat (ITT) population (N=119). A pre-specified subgroup analysis of pain sensitivity was conducted using an interaction term in the model. RESULTS: No differences were found between active and sham treatment on PGIC scores at 3-months (0.34, 95% CI [-0.37, 1.04], p=0.351) in the ITT population. However, in subjects with higher pain sensitivity (n=60), PGIC was significantly greater for active treatment compared to sham (1.19, 95% CI [0.24, 2.13], p=0.014). FIQR total score (-7.47, 95% CI [-12.46, -2.48], p=0.003), FIQR pain item (-0.62, 95% CI [-1.17, -0.06], p=0.029), BPI Interference (-0.70, 95% CI [-1.30, -0.11], p=0.021) and PDQ (-1.69, 95% CI [-3.20, -0.18], p=0.028) exhibited significant improvements for active treatment compared to sham in the ITT population. Analgesics use was stable and comparable in both groups. CONCLUSION: This study demonstrated modest treatment effects of reduced disease impact, pain and functional impairment from wearable TENS in individuals with fibromyalgia. Subjects with higher pain sensitivity exhibited larger treatment effects than those with lower pain sensitivity. Wearable TENS may be a safe treatment option for people with fibromyalgia. CLINICALTRIALSGOV REGISTRATION: NCT03714425.

Establishment of an Individualized Chronotherapy, Autonomic Nervous System, and Variability-Based Dynamic Platform for Overcoming the Loss of Response to Analgesics.

BACKGROUND: Control of chronic pain and mainly the partial or complete loss of response to analgesics is a major unmet need. Multiple mechanisms underline the development of tolerance to analgesics in general and specifically to opioids. The autonomic nervous system (ANS) plays a role in the development of analgesic tolerance and chronobiology. OBJECTIVES: To review the mechanisms associated with the development of nonresponsiveness to analgesics. STUDY DESIGN: Literature review. SETTING: The review is followed by a description of a new method for overcoming resistance and improving the response to analgesics. METHODS: Conducted a detailed review of the relevant studies describing the mechanisms that underlie tolerance to pain medications, and the potential roles of the ANS and chronobiology in the development of drug resistance. RESULTS: The autonomic balance is reflected by heart rate variability, an example of a fundamental variability that characterizes biological systems. Chronotherapy, which is based on the circadian rhythm, can improve the efficacy and reduce the toxicity of chronic medications. In this article, we present the establishment of an individualized variability- and chronobiology-based therapy for overcoming the compensatory mechanisms associated with a loss of response to analgesics. We describe the premise of implementing personalized signatures associated with the ANS, and chronobiology, as well as with the pathophysiology of pain for establishing an adaptive model that could improve the efficacy of opioids, in a highly dynamic system. LIMITATIONS: The studies presented were selected based on their relevance to the subject. CONCLUSIONS: The described variability-based system may ensure prolonged effects of analgesics while reducing the toxicity associated with increasing dosages.

Online group pain management for chronic pain: Preliminary results of a novel treatment approach to teletherapy.

OBJECTIVE: This pilot study was designed to determine the feasibility, tolerability, safety, and efficacy of group teletherapy for persons with chronic pain. The aim was to present preliminary outcomes of an open trial of group cognitive behavioural therapy (CBT) teletherapy compared with an in-person chronic pain patient group. METHODS: We recruited 47 chronic pain patients to participate in an 8-session, 2-hour-per-week, online, structured, CBT-oriented pain management group using WebEx and compared them with 46 subjects who participated in a parallel, content-matched, in-person, weekly group. Both groups included goal setting, skills training, relaxation exercises, group discussion, and practice assignments. All subjects completed baseline measures, which were repeated post-treatment. Those in the online group participated in weekly telephone interviews and rated the perceived helpfulness of the remote group. RESULTS: The average age of the online group participants was 54.5 ( ± 14.3) years and 70.2% were female, compared with 59.7 ( ± 13.0) years of age and 57.8% females among the in-person group members. On follow-up, both CBT groups showed modest improvements on the outcome measures. Results of this preliminary investigation comparing online teletherapy with in-person CBT suggest similar benefit. Many participants in the online group rated their experience as very helpful (62.5%; 7-10/10) and most would recommend this programme to others (93.7%; 7-10/10). DISCUSSION: Preliminary findings suggest that online group CBT may be as effective in improving coping among persons with chronic pain as in-person groups. More rigorous controlled trials are needed to adequately assess the outcome benefit of online teletherapy for chronic pain.

Secondary Impact of Social Media via Text Message Screening for Type 2 Diabetes Risk in Kuwait: Survey Study.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is an international problem of alarming epidemic proportions. T2DM can develop due to multiple factors, and it usually begins with prediabetes. Fortunately, this disease can be prevented by following a healthy lifestyle. However, many health care systems fail to properly educate the public on disease prevention and to offer support in embracing behavioral interventions to prevent diabetes. SMS messaging has been combined with cost-effective ways to reach out to the population at risk for medical comorbidities. To our knowledge, the use of nationwide SMS messaging in the Middle East as a screening tool to identify individuals who might be at risk of developing T2DM has not been reported in the literature. OBJECTIVE: The primary aim of this study was to assess the feasibility of conducting a series of SMS messaging campaigns directed at random smartphone users in Kuwait for the detection and prevention of T2DM. It was predicted that 1% of those receiving the text message would find it relevant and participate in the study. The secondary aim of this study was to assess the incidence of participation of those who were forwarded the initial text message by family members and friends. METHODS: In this study, 5 separate text message screening campaigns were launched inviting recipients to answer 6 questions to determine the risk of developing T2DM. If subjects agreed to participate, a link to the prediabetes screening test devised by the Centers for Disease Control and Prevention was automatically transmitted to their mobile devices. Those identified as high risk were invited to participate in a diabetes prevention program. RESULTS: A total of 180,000 SMSs were sent to approximately 6% of the adult population in Kuwait. Of these, 0.14% (260/180,000) of the individuals who received the SMS agreed to participate, of whom 58.8% (153/260) completed the screening. Surprisingly, additional surveys were completed by 367 individuals who were invited via circulated SMS messages forwarded by family members and friends. Altogether, 23.3% (121/520) qualified and agreed to participate in a diabetes prevention program. The majority of those who chose to participate in the prevention program were overweight, aged 45-65 years, and reported being less physically active than those who chose not to participate (χ22=42.1, P<.001). CONCLUSIONS: Although health care screening via text messaging was found to have limited effectiveness by itself, it exhibited increased reach through shared second-party social media messaging. Despite the fact a subpopulation at possible risk of developing T2DM could be reached via text messaging, most responders were informed about the screening campaign by family and friends. Future research should be designed to tap into the benefits of social media use in health risk campaigns.

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.

Does bedtime matter among patients with chronic pain? A longitudinal comparison study.

INTRODUCTION: Chronic pain patients frequently report having sleep disturbances and many tend to stay up during the night and then sleep into the day. OBJECTIVES: This study was designed to compare a heterogeneous group of persons with chronic pain who reported typically going to bed between the hours of 9 pm and midnight with those who go to bed at other hours of the day and night. METHODS: Two hundred seventy-nine participants were divided between those who reported going to bed between the hours of 9 pm and midnight (N = 205) and those who reported having atypical bedtimes (N = 74) based on pre-post questionnaire data and average pain assessments from a smartphone pain application (app). RESULTS: Those individuals in the atypical bedtime group reported waking up more frequently and getting fewer hours sleep (P < 0.05). These individuals also reported significantly higher pain scores, activity interference, and taking more prescription opioid medication compared with those who had typical bedtimes (P < 0.05). Based on average 3-month daily assessments, those subjects with an atypical bedtime consistently reported more sleep disturbances, pain, activity interference, negative mood, and general worsening conditions over time, and elevated pain catastrophizing, pain-related disability, emotional distress scores, and more prescription medication for pain at 3-month follow-up (P < 0.01). CONCLUSION: These results support the importance of providers asking patients with pain about what time they typically go to bed at night to gain a greater understanding of their lifestyle habits. Future studies are needed to further determine the importance of maintaining a typical bedtime among patients with chronic pain.

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.

Determining Pain Catastrophizing From Daily Pain App Assessment Data: Role of Computer-Based Classification.

This study compared persons with chronic pain who consistently reported that their pain was worsening with those who reported that their pain was improving or remaining the same per daily assessment data from a smartphone pain app. All participants completed baseline measures and were asked to record their progress every day by answering whether their overall condition had improved, remained the same, or gotten worse (perceived change) on a visual analogue scale. One hundred forty-four individuals with chronic pain who successfully entered daily assessments were included. Those persons who were classified as worse showed significantly higher pain intensity scores, greater activity interference, higher disability and mood disturbance scores, and higher scores on the Pain Catastrophizing Scale both at baseline and after 3 months (P < .001). Repeated measures analyses and multilevel modeling of perceived change data over different time intervals of 20 assessments over 40 days, 10 assessments over 20 days, and 5 assessments over 10 days were examined. These analyses demonstrated that group classification of better, same, and worse could be reliably determined, even with as few as 5 assessments. These results support the use of innovative mobile health technology to identify individuals who are prone to catastrophize about their pain. Perspective: This study demonstrated that daily assessment of overall perceived change with a smartphone pain app was positively correlated with the Pain Catastrophizing Scale and capturing short-term daily assessment trends data using computer-based classification methods might be a future way to help to identify individuals who tend to catastrophize about their pain.

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.

Longitudinal trial of a smartphone pain application for chronic pain patients: Predictors of compliance and satisfaction.

Introduction This study was designed to determine the feasibility, tolerability, safety and efficacy of a smartphone pain application (app) among chronic pain patients over a six-month trial. The app was designed for both Android and iPhone devices and enabled users with chronic pain to assess, monitor, and communicate their status to their providers. Methods We recruited 90 chronic pain patients to use the pain app. All subjects completed baseline measures and were asked to record their progress every day. All participants were supplied an activity monitor. Results Average age of the participants was 46.7 years (range 18-79), 64.4% were female and 31.1% reported multiple pain sites. Satisfaction was rated at three and six months. The app was found to be easily introduced and well tolerated. In general, those who used the app more often were more satisfied with the program ( p < 0.05), although satisfaction ratings of the pain app diminished with time. Greater use of the app and frequent daily assessment entries were found to be related to an overall improvement in mood. However, contrary to our hypotheses, frequent use of the app did not have a positive effect on pain or activity. Those who were more satisfied with the app reported more pain-related disability and were less active than those who were less satisfied with the app. No safety issues were encountered. Discussion Strategies to make the program more engaging and to improve motivation to use the app would be important in the future development and use of a smartphone pain app.

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.

Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure.

BACKGROUND: Prostacyclins improve symptoms and survival in pulmonary arterial hypertension (PAH). In response to risks associated with external delivery systems, an implantable IV infusion system was developed. A multicenter, prospective, single-arm, clinical trial (DelIVery for PAH) was conducted to evaluate this system for treprostinil in PAH. This analysis describes the findings related to the implant procedure. METHODS: Patients (N = 64) with PAH (World Health Organization group 1) receiving stable IV treprostinil were enrolled. Patients were transitioned to a temporary peripheral IV infusion catheter prior to the procedure. System implantation was performed at 10 centers under general anesthesia or deep IV sedation by clinicians from various specialties. Central venous access was via the cephalic, subclavian, jugular, or axillary vein. Using an introducer and fluoroscopic guidance, the distal tip of the infusion catheter was placed at the superior caval-atrial junction. The catheter was tunneled from the venous access site to an abdominal subcutaneous pocket, where the pump was placed. RESULTS: Of the 64 patients enrolled, four exited prior to implantation. All 60 implant procedures were successful. At baseline, all patients were receiving treprostinil via an external pump at a mean dose of 71.4 ± 27.8 ng/kg/min (range: 22-142 ng/kg/min). The implant averaged 102 ± 32 min (range: 47-184 min). Clinically significant implant procedure-related complications included one pneumothorax, two infections, and one episode of atrial fibrillation. There were three postimplantation catheter dislocations in two patients. Common implant-related events that were not complications included implant site pain (83%) and bruising (17%). CONCLUSIONS: The procedure for inserting a fully implantable system for treprostinil was successfully performed, with few complications. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov.

Integration of Mobile Health Technology in the Treatment of Chronic Pain: A Critical Review.

This article provides a critical overview and best-evidence synthesis of the use of mobile health (mHealth) technology among persons with chronic pain and their health care providers and examines the future benefits and barriers of implementing mHealth technology in clinical care. We critically review articles about electronic pain diaries, pain assessment programs, text messaging, and smartphone pain apps for management of persons with pain. Also presented are findings on the utility of activity trackers and use of telehealth to deliver cognitive behavioral therapy. Finally, barriers, study gaps, and future challenges of incorporating mobile technology for chronic pain are discussed. Although the future of mHealth technology and telemedicine in clinical practice is promising, this critical review highlights the need for rigorous studies to establish an association of the use of mHealth technology with improved quality of life, functional autonomy, and decreased hospital use.

Prevalence of chronic pain with neuropathic characteristics: a randomized telephone survey among medical center patients in Kuwait.

BACKGROUND: Chronic pain with neuropathic characteristics is considered to be an international health problem. However, surveys on the actual incidence of neuropathic pain have not been conducted in many Middle East countries, including Kuwait. The aim of this study was to examine the incidence of pain and medical comorbidities among a random sample of patients treated at a large medical center in Kuwait. METHODS: A list of 1,000 patients was created from the hospital medical record system, and a telephone survey was conducted on 759 patients who responded to the phone call, of which 67.2% (N=510) participated. Those who stated that they had pain every day for the past 3 months were invited to answer additional questions about their pain. RESULTS: Fifty-six percentage of those surveyed (N=283) reported experiencing chronic pain. Total average age was 49.2 years (SD=14.5), 45.5% were female, and 70.5% were Kuwaiti nationals. Most (74.3%) reported having diabetes and one-third (32.2%) showed evidence of neuropathic pain characteristics (mean DN4=2.8, SD=1.7). Other comorbid medical conditions were prevalent (48.4% hypertension, 30.4% arthritis, 22.6% heart disease, and 20.4% asthma) with an average of 2.3 (SD=1.3) medical problems per person. Those with pain tended to be older, female, unemployed, and overweight (p<0.01). The pain was mostly located in the lower extremities and those with neuropathic pain tended to report a higher intensity of pain and a higher frequency of seeking treatment for their pain in a clinic or hospital (p<0.05). Most relied on over-the-counter medications for their pain (38.1%). Very few were taking prescription medication for their pain. CONCLUSION: This survey suggests that chronic pain is more prevalent in a medical population in Kuwait than previously anticipated. Health care services and behavioral interventions to improve lifestyle changes in Kuwait and other Arab countries are needed to positively impact pain and reduce other comorbidities.

A Pilot Comparison of a Smartphone App With or Without 2-Way Messaging Among Chronic Pain Patients: Who Benefits From a Pain App?

OBJECTIVES: The overall aim of this study was to determine the effect of introducing a smartphone pain application (app), for both Android and iPhone devices that enables chronic pain patients to assess, monitor, and communicate their status to their providers. METHODS: This study recruited 105 chronic pain patients to use a smartphone pain app and half of the patients (N=52) had 2-way messaging available through the app. All patients completed baseline measures and were asked to record their progress every day for 3 months, with the opportunity to continue for 6 months. All participants were supplied a Fitbit to track daily activity. Summary line graphs were posted to each of the patients' electronic medical records and physicians were notified of their patient's progress. RESULTS: Ninety patients successfully downloaded the pain app. Average age of the participants was 47.1 (range, 18 to 72), 63.8% were female and 32.3% reported multiple pain sites. Adequate validity and reliability was found between the daily assessments and standardized questionnaires (r=0.50) and in repeated daily measures (pain, r=0.69; sleep, r=0.83). The app was found to be easily introduced and well tolerated. Those patients assigned to the 2-way messaging condition on average tended to use the app more and submit more daily assessments (95.6 vs. 71.6 entries), but differences between groups were not significant. Pain-app satisfaction ratings overall were high. DISCUSSION: This study highlights some of the challenges and benefits in utilizing smartphone apps to manage chronic pain patients, and provides insight into those individuals who might benefit from mHealth technology.

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.