Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial.

Importance: Opioid use for chronic nonmalignant pain can be harmful. Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration: isrctn.org Identifier: ISRCTN49470934.

Investigating mental defeat in individuals with chronic pain: Protocol for a longitudinal experience sampling study.

INTRODUCTION: Previous qualitative and cross-sectional research has identified a strong sense of mental defeat in people with chronic pain who also experience the greatest levels of distress and disability. This study will adopt a longitudinal experience sampling design to examine the within-person link between the sense of mental defeat and distress and disability associated with chronic pain. METHODS AND ANALYSIS: We aim to recruit 198 participants (aged 18-65 years) with chronic pain, to complete two waves of experience sampling over 1 week, 6 months apart (time 1 and time 2). During each wave of experience sampling, the participants are asked to complete three short online surveys per day, to provide in-the-moment ratings of mental defeat, pain, medication usage, physical and social activity, stress, mood, self-compassion, and attention using visual analogue scales. Sleep and physical activity will be measured using a daily diary as well as with wrist actigraphy worn continuously by participants throughout each wave. Linear mixed models and Gaussian graphical models will be fit to the data to: (1) examine the within-person, day-to-day association of mental defeat with outcomes (ie, pain, physical/social activity, medication use and sleep), (2) examine the dynamic temporal and contemporaneous networks of mental defeat with all outcomes and the hypothesised mechanisms of outcomes (ie, perceived stress, mood, attention and self-compassion). ETHICS AND DISSEMINATION: The current protocol has been approved by the Health Research Authority and West Midlands-Solihull Research Ethics Committee (Reference Number: 17/WM0053). The study is being conducted in adherence with the Declaration of Helsinki, Warwick Standard Operating Procedures and applicable UK legislation.

Mental Defeat and Suicidality in Chronic Pain: A Prospective Analysis.

Living with chronic pain has been identified as a significant risk factor for suicide. Qualitative and cross-sectional studies have reported an association between mental defeat and suicidal thoughts and behavior in patients with chronic pain. In this prospective cohort study, we hypothesized that higher levels of mental defeat would be associated with increased suicide risk at a 6-month follow-up. A total of 524 patients with chronic pain completed online questionnaires measuring variables related to suicide risk, mental defeat, sociodemographic, psychological, pain, activity, and health variables. At 6 months, 70.8% (n = 371) of respondents completed the questionnaires again. Weighted univariate and multivariable regression models were run to predict suicide risk at 6 months. The clinical suicide risk cutoff was met by 38.55% of the participants at baseline and 36.66% at 6 months. Multivariable modeling revealed that mental defeat, depression, perceived stress, head pain, and active smoking status significantly increased the odds of reporting higher suicide risk, while older age reduced the odds. Receiver operating characteristic (ROC) analysis showed that assessment of mental defeat, perceived stress, and depression is effective in discriminating between 'low' and 'high' suicide risk. Awareness of the prospective links from mental defeat, depression, perceived stress, head pain, and active smoking status to increased suicide risk in patients with chronic pain may offer a novel avenue for assessment and preventative intervention. PERSPECTIVE: Results from this prospective cohort study suggest that mental defeat is a significant predictor of increased suicide risk among patients with chronic pain, along with depression, perceived stress, head pain, and active smoking status. These findings offer a novel avenue for assessment and preventative intervention before risk escalates.

Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

INTRODUCTION: Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain. METHODS AND ANALYSIS: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years. ETHICS AND DISSEMINATION: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website. TRIAL REGISTRATION NUMBER: ISRCTN49470934; Pre-results.

Tracheal Extubation of Patients With Cervical Spine Injury: A Case Report and Review of Literature.

In patients with cervical spine injuries, emergence from anesthesia and tracheal extubation can prove as challenging to the anesthesiologist as the tracheal intubation. We report a case of a patient with a potentially unstable cervical spine injury who presented for a nonspinal surgery and experienced agitation on emergence from anesthesia. The use of an intravenous sedative was necessary to ensure cervical spine immobilization but was complicated by severe respiratory depression and the need for reintubation and admission to intensive care. The case report is followed by a review of literature relating to safe extubation of patients with cervical spine injuries. Possible complications during emergence and various methods to prevent these complications are discussed.

Facet joint injections for people with persistent non-specific low back pain (Facet Injection Study): a feasibility study for a randomised controlled trial.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. OBJECTIVES: To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. DESIGN: The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. SETTING: Five NHS acute trusts in England. PARTICIPANTS: Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with 'best usual care' (BUC) or BUC alone. INTERVENTIONS: All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. MAIN OUTCOME MEASURES: Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. RESULTS: Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. LIMITATIONS: Poor recruitment was a limiting factor. CONCLUSIONS: This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain. FUTURE WORK: Further work is needed to test recruitment from alternative clinical situations. TRIAL REGISTRATION: EudraCT 2014-000682-50 and Current Controlled Trials ISRCTN93184143. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 30. See the NIHR Journals Library website for further project information.

Chronic pelvic pain due to peripheral neuropathy: a case report.

BACKGROUND: There are numerous possible causes for chronic pelvic pain. Evaluation of these causes should begin with the least invasive form of assessment. CASE: A 28-year-old woman with chronic pelvic pain underwent an array of investigations and surgical interventions without relief of pain. When she was admitted to hospital because of a flare up of pelvic pain, the chronic pain service was consulted. The presentation of stabbing pain that was reproduced by eliciting focal tenderness over the course of ilioinguinal nerve made nerve entrapment a possible diagnosis. An ilioinguinal nerve block was performed, resulting in resolution of the pain. CONCLUSION: Chronic pelvic pain due to peripheral neuropathy can mimic visceral pain, presenting a diagnostic challenge.

Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial.

BACKGROUND: The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin. METHODS/DESIGN: We present here the protocol for a randomised controlled feasibility trial for a main trial to test the above hypotheses. Patients referred to secondary care with persistent non-specific low back pain will be screened and invited to take part in the study. Those who meet the eligibility criteria will be invited for a physiotherapy assessment to confirm trial eligibility and for baseline data collection. All participants (n = 150) will be offered the best usual care package with physical and psychological components. Those randomised into the intervention arm (n = 75) will, in addition, receive intra-articular facet joint injections with local anaesthetic and steroids. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0-10 scale. Questionnaire follow-up will be at 3, 6, and 12 months. Evaluation of trial processes and health economic analyses, including a value of information analysis, will be undertaken. The process evaluation will be mixed methods and will include the views of all stakeholders. DISCUSSION: Whilst this trial is a feasibility study it is currently one of the largest trials in this area. The outcomes will provide some evidence on the use of facet joint injections for patients with clinically diagnosed facet joint pain. TRIAL REGISTRATION: EudraCT identifier 2014-000682-50, (registered on 12 February 14). ISRCTN registry number: ISRCTN93184143 DOI 10.1186/ISRCTN93184143 (registered on 27 February 2014).

Ultrasound-guided peripheral regional blockade in patients with Charcot-Marie-Tooth disease: a review of three cases.

PURPOSE: To describe the clinical presentation of three patients with Charcot-Marie-Tooth disease, who underwent uneventful upper limb surgery following successful peripheral nerve blockade, and to review the anesthetic implications in patients with Charcot-Marie-Tooth disease. CLINICAL FEATURES: In three patients with Charcot-Marie-Tooth disease presenting for surgery of the upper limb, the motor response, following nerve stimulation, was suboptimal. However, ultrasound guidance was effective in visualizing the needle-nerve interaction, and local anesthetic was injected around the nerves. Good block ensued and surgery proceeded in all patients without complications. No exacerbation of the neurological condition was observed in any patient. CONCLUSIONS: Charcot-Marie-Tooth disease is a demyelinating, hereditary, motor and sensory neuropathy characterized by abnormalities of nerve conduction. Regional anesthesia of the upper limb is feasible in these patients, and these cases show that ultrasound guidance makes peripheral nerve block possible in patients for whom traditional methods of nerve localization fail.

Opioids and brain imaging.

Since the introduction of the gate-control theory, a plethora of evidence to support the spinal processing of pain signals has come to light. Cognitive and affective aspects of the pain experience indicate the importance of supraspinal structures, but the biological mechanisms have remained inadequately explored. Within the past decade, imaging techniques have emerged that enable in vivo assessment of the central opioidergic system and the central processing of pain. The two most important imaging modalities to this end are functional magnetic resonance imaging (fMRI) and positron emission tomography (PET). This article will describe the underlying principles of these techniques and explain their importance in determining the loci of opioidergic pathways and their neuromodulatory influence on acute and chronic pain conditions, role in placebo effects, implication in drug dependence, and potential role in studying the analgesic efficacy of new drugs.