Long-term safety and efficacy of sublingual ketamine troches/lozenges in chronic non-malignant pain management.

BACKGROUND: Chronic non-malignant pain is a disabling condition that results in a reduction in function and quality of life when inadequately managed. Sublingual ketamine has been shown to be efficacious for use in chronic pain. Despite its use for decades in chronic non-malignant pain, there is no published long-term data on safety, side-effects or adverse drug reactions. AIM: The aim of this case-series is to provide the initial evidence for safety and efficacy in this patient group. METHODS: We present a retrospective review of 29 (n = 29) patients from a metropolitan tertiary pain service who have been receiving sublingual ketamine troches/lozenges between the period of 2012 and 2019. Patients were identified from the outpatient pain clinic, who had been admitted for inpatient subcutaneous ketamine infusions as part of opiate detoxification or management of central sensitisation due to a chronic neuropathic pain syndrome. An initial review was performed to check the patient started taking the ketamine troches. Each of these medical records was reviewed manually to extract information to a datasheet. RESULTS: There was a wide range of dosages used from 25 to 600 mg in divided doses. The duration of treatment ranged 2-89 months. There was no association with either the dosage or duration of treatment and frequency of side-effects. There was an overall reduction in the use of opioids, gabapentinoids or benzodiazepines in 59% of patients with 39% having a complete cessation of an analgesic agent. Side-effects were reported in 24%, but only 7% discontinued the treatment due to the side-effect (drowsiness). There were no reports of renal impairment, cystitis or hepatotoxicity. DISCUSSION: This retrospective case-series has demonstrated that sublingual ketamine is a safe and effective analgesic agent to use in chronic non-malignant pain management. It is indicated in a variety of chronic pain conditions and has an excellent safety profile, with no association between the frequency in side-effects and duration of therapy or total daily dosages. The study has also shown that the 'safe' dose may be higher than the previous consensus.

Interventions to optimize prescribed medicines and reduce their misuse in chronic non-malignant pain: a systematic review.

PURPOSE: Sub-optimal opioid prescribing and use is viewed as a major contributor to the growing opioid crisis. This study aims to systematically review the nature, process and outcomes of interventions to optimize prescribed medicines and reduce their misuse in chronic non-malignant pain (CNMP) with a particular focus on minimizing misuse of opiates. METHODS: A systematic review of literature was undertaken. Search of literature using Medline, EMBASE and CINAHL databases from 2000 onwards was conducted. Screening and selection, data extraction and risk of bias assessments were undertaken by two independent reviewers. Narrative synthesis of the data was conducted. RESULTS: A total of 21 studies were included in the review, of which three were RCTs. Interventions included clinical (e.g. urine drug testing, opioid treatment contract, pill count), behavioural (e.g. electrical diaries about craving), cognitive behavioural treatment and/or educational interventions for patients and healthcare providers delivered as a single or as a multi-component intervention. Medication optimization outcomes included aspects of misuse, abuse, aberrant drug behaviour, adherence and non-adherence. Although all evaluations showed improvement in medication optimization outcomes, multi-component interventions were more likely to consider and to have shown improvement in clinical outcomes such as pain intensity, quality of life, psychological states and functional improvement compared to single-component interventions. CONCLUSIONS: A well-structured CNMP management programme to promote medicines optimization should include multi-component interventions delivered by a multidisciplinary team of healthcare professionals and target both healthcare professionals and patients. There was heterogeneity in definitions applied and interventions evaluated. There is a need for the development of clear and consistent terminology and measurement criteria to facilitate better comparisons of research evidence.

Effectiveness and tolerability of transdermal buprenorphine patches: a multicenter, prospective, open-label study in Asian patients with moderate to severe chronic musculoskeletal pain.

BACKGROUND: We examined the effectiveness and tolerability of transdermal buprenorphine (TDB) treatment in real-world setting in Asian patients with musculoskeletal pain. METHODS: This was an open-label study conducted in Hong Kong, Korea, and the Philippines between June 2013 and April 2015. Eligible patients fulfilled the following criteria: 18 to 80 years of age; clinical diagnosis of osteoarthritis, rheumatoid arthritis, low back pain, or joint/muscle pain; chronic non-malignant pain of moderate to severe intensity (Box-Scale-11 [BS-11] pain score ≥ 4), not adequately controlled with non-opioid analgesics and requiring an opioid for adequate analgesia; and no prior history of opioid treatment. Patients started with a 5 µg/h buprenorphine patch and were titrated as necessary to a maximum of 40 µg/h over a 6-week period to achieve optimal pain control. Patients continued treatment with the titrated dose for 11 weeks. The primary efficacy endpoint was the change in BS-11 pain scores. Other endpoints included patients' sleep quality and quality of life as assessed by the 8-item Global Sleep Quality Assessment Scale (GSQA) questionnaire and the EuroQol Group 5-Dimension Self-Report Questionnaire-3 Level version (EQ-5D-3 L), respectively. Tolerability was assessed by collecting adverse events. RESULTS: A total of 114 eligible patients were included in the analysis. The mean BS-11 score at baseline was 6.2 (SD 1.6). Following initiation of TDB, there was a statistically significant improvement in BS-11 score from baseline to visit 3 (least squares [LS] mean change: -2.27 [95% CI -2.66 to -1.87]), which was maintained till the end of the study (visit 7) (LS mean change: -2.64 [95% -3.05 to -2.23]) (p < 0.0001 for both). The proportion of patients who rated sleep quality as 'good' increased from 14.0% at baseline to 26.9% at visit 6. By visit 6, the mean EQ VAS score increased by 7.7 units (SD 17.9). There were also significant improvements in patients' levels of functioning for all EQ-5D-3 L dimensions from baseline at visit 6 (p < 0.05 for all). Seventy-eight percent of patients reported TEAEs and 22.8% of patients discontinued due to TEAEs. TEAEs were generally mild to moderate in intensity (96.5%). CONCLUSIONS: TDB provides effective pain relief with an acceptable tolerability profile over the 11-week treatment period in Asian patients with chronic musculoskeletal pain. More studies are needed to examine the long-term efficacy and safety of TBD treatment in this patient population. TRIAL REGISTRATION: ClinicalTrials.gov NCT01961271 . Registered 7 October 2013 (retrospectively registered; first patient was enrolled on 28 June 2013 and last patient last visit date was 26 Apr 2015).

Associations between demographics and health-related quality of life for chronic non-malignant pain patients treated at a multidisciplinary pain centre: a cohort study.

OBJECTIVE: To describe the associations between demographics and health-related quality of life for chronic non-malignant pain patients. DESIGN: A cohort study. SETTING: A multidisciplinary Danish pain centre. STUDY PARTICIPANTS: All patients treated at the centre between 2007 and 2013. MAIN OUTCOME MEASURES: Levels of pain, anxiety and depression, and physical and mental status. The Hospital Anxiety and Depression Scale and the Medical Outcomes Study Short-Form Health Survey (SF-36) were used. RESULTS: A total of 1176 patients were included. The majority were women (64%), the mean age was 46.7 ± 14.4 (range 18-89), and 21% were able to work full or part time. On a Numeric Rating Scale from 0 to 10, median pain-intensity was 8 (interquartile range 7-8) and pain-discomfort 8 (interquartile range 7-9) at time of referral. More than half of the patients had symptoms of anxiety and depression. Most of the individual SF-36 domains had median scores between 0 and 40 (Scale from 0 to 100). Patients younger than 50 years of age as well as patients on sick leave/disability pension had significantly lower SF-36 scores. Level of pain, anxiety and depression decreased and SF-36-scores increased significantly after a course of treatment which in most cases consisted of both medical, physiotherapeutic and psychological treatment as well as health-oriented education. The chi-square test, Mann-Whitney U-test, the Kruskal-Wallis and Wilcoxon Signed-rank test were used for analyses. CONCLUSIONS: In order to improve treatment at a multidisciplinary pain centre, it may be of value to target treatments to different patient subgroups based on, amongst other things, age and employment status.

Integrated Approach to Chronic Pain-The Role of Psychosocial Factors and Multidisciplinary Treatment: A Narrative Review.

BACKGROUND: Chronic non-malignant pain represents a growing global public health priority. Chronic pain is multifactorial, with numerous biological, psychological, and social factors contributing to this pain syndrome. It affects not only the patients, impairing their quality of life, but also their family and social environment. Chronic pain is a diagnosis and requires effective and sustainable treatment strategies. OBJECTIVE: Our aim was to critically review the available evidence on the importance of different approaches in treating patients with chronic non-malignant pain, emphasizing the effectiveness of integrating psychological and social factors within a multidisciplinary framework. METHODS: This was a non-systematic narrative review of the basic and recent literature analyzing approaches to the treatment of chronic non-malignant pain. The inclusion criteria for the papers were chronic non-malignant pain, treatment approach, review, and original research papers published in English in the last five years (PubMed search), and the basic literature was selected from the references of new papers according to the knowledge and experience of the authors. RESULTS: This literature review included 120 papers, of which 83 were basic, and 37 were new, published in the last 5 years (2018-2023). The results show that both the basic and newly published literature advocate for a biopsychosocial approach to treating chronic pain. CONCLUSIONS: New findings, compared to the earlier literature, indicate a new classification of chronic pain into primary and secondary. Chronic pain should be approached with a biopsychosocial model within a multidisciplinary treatment framework. This model addresses the complex interplay of biological, psychological, and social factors, offering a holistic strategy for effective pain management.

Multidimensional Analysis of Quality of Life in Patients with Chronic Non-Cancer Pain and Short- and Long-Term Intrathecal Analgesic Therapy.

Background: Intrathecal drug delivery (IDD) is part of the fourth analgesic step. Evidence on the quality of life of patients with refractory chronic non-cancer pain (CNCP) using these devices and their long-term outcomes is scarce. This study aims to evaluate patients with IDD to assess their HRQoL. Additionally, the study seeks to understand the patients' satisfaction with the treatment and changes in pain magnitude over time. Methods: Adult patients with CNCP and intrathecal drug delivery systems (IDDS) were included. The study population was divided into two groups: less than and more than 15 years of treatment. HRQoL was analyzed using validated questionnaires. Pain reduction was assessed using the visual analog scale (VAS), and treatment satisfaction was evaluated using the Patient Global Impression of Improvement scale. Results: The results indicate a poor HRQoL in IDD patients, with better scores in the group with ≥15 years of treatment. Pain reduction was similar in both groups, and patients reported a positive satisfaction level with the treatment. Conclusions: HRQoL in CNCP patients is severely affected. Long-term IDD patients have a similar or even better HRQoL in some respects compared to those with shorter follow-ups. IDD patients experienced pain reduction, with most feeling better or much better.

Timely Palliative Care Could Be Another Benefit for Cancer Patients with Non-Malignant Pain.

Cancer patients, as well as individuals in the general population, suffer from non-malignant pain (NMP), although with variable prevalence in the few studies dealing with this topic [...].

Logic model for opioid safety in chronic non-malignant pain management, an in-depth qualitative study.

BACKGROUND: Opioids are commonly used for the management of chronic non-malignant pain in Pakistan; but there is a lack of literature around precursors or motivators in the use of opioids. AIM: The study holistically explored factors contributing towards the unsafe use of opioids and identifies strategies to overcome them. METHOD: Exploratory qualitative methods using interviews, focus groups and non-participant observational case studies were used. Interviews and focus groups were carried out face-to-face as well as virtually and observations were conducted in community pharmacies in Islamabad and Khyber Pukhtoon Khuwa province, Pakistan. Data were collected from 4 stakeholder groups; pharmacy policy makers (n = 11), people with chronic non-malignant pain (n = 14), doctors (n = 31) and community pharmacists (n = 36) by purposive critical case sampling method. Data were analysed inductively using reflexive thematic analysis and then deductively mapped to a social ecological framework. Non-participant observations were analysed using a cross case synthesis using explanation building technique. Data from all three methods were triangulated to develop a logic model. RESULTS: Identified factors at macro (regulation), meso (social perceptions of pain and opioids) and micro levels (uncontrolled pain, self-medication, health literacy) and strategies are presented holistically and were used to develop a logic model for the prevention and mitigation of factors currently causing unsafe use of opioids. CONCLUSION: The study provides an in-depth view of factors contributing towards diversion of pharmaceutical opioids and can help guide national and international policy makers in their future initiatives to promote safe use of opioids in the management of chronic non-malignant pain in Pakistan.

'It was a joint plan we worked out together'. How the I-WOTCH programme enabled people with chronic non-malignant pain to taper their opioids: a process evaluation.

BACKGROUND: The Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial found that a group-based educational intervention to support people using strong opioids for chronic non-malignant pain helped a significant proportion of people to stop or decrease opioid use with no increase in pain-related disability. We report a linked process evaluation of the group-based intervention evaluated in comparison to a usual-care control group that received a self-help booklet and relaxation CD. METHODS: We interviewed 18 intervention facilitators, and 20 intervention and 20 control participants who had chronic non-malignant pain and were recruited from general (family) practices in the UK. Quantitative data included change mechanism questions on the trial questionnaires which explored motivation, expectations and self-efficacy. Fidelity was assessed by listening to a sample of audio-recorded group sessions and nurse consultations. Quantitative and qualitative data were integrated using 'follow a thread' and a mixed-methods matrix. FINDINGS: Four overarching themes emerged: (1) the right time to taper, (2) the backdrop of a life with chronic pain, (3) needing support and (4) the benefits of being in a group. Delivery fidelity was good, adherence (83%) and competence (79%) across a range of intervention groups. Staff delivering the intervention found three typical responses to the intervention: resistance, open to trying and feeling it was not the right time. The group experience was important to those in the intervention arm. It provided people with a forum in which to learn about the current thinking about opioid usage and its effects. It also gave them examples of how feasible or personally relevant coming off opioids might be. CONCLUSION: The process evaluation data showed that the I-WOTCH intervention was well delivered, well received and useful for most interviewees. Being 'the right time' to taper and having support throughout tapering, emerged as important factors within the context of living with chronic pain. TRIAL REGISTRATION NUMBER: ISRCTN49470934.

Patient Perspectives on the Appropriate Use of Prescribed Opioids in Chronic Non-Malignant Pain: Analysis of Online Forums Using Theoretical Domains Framework.

Purpose: In view of concerns about the harmful effects of long-term use and patient misuse of opioids in chronic non-malignant pain, this study provides insight into patients' perspectives on their experience of living with chronic non-malignant pain (CNMP), prescribed opioid use, and optimisation. Patients and Methods: Data were collected from active UK-based CNMP specific or general health forums that do not require registration, with more than 100 members. English written thread posts between 2016 and 2020 were systematically searched from the forum search bar using different keywords and then analysed using the Theoretical Domains Framework (TDF). Results: Findings showed that chronic pain is a dominant, life-altering experience with physical, psychological and social impact. Findings highlighted that opioid optimisation is facilitated by patients' knowledge and understanding, practical coping strategies and supportive relationships with healthcare providers and others in their surroundings. The study found that barriers to opioid optimisation included lack of availability of alternatives, difficulties accessing health services and broken relationships with clinicians. Conclusion: Analysis of CNMP patients' posts on online forums highlighted the devastating impact of pain on social functioning, relationships and mental health. Patients emerged as knowledge seekers prepared to engage in opioid optimisation.

Non-Medical Factors Associated with the Outcome of Treatment of Chronic Non-Malignant Pain: A Cross-Sectional Study.

BACKGROUND: Chronic pain is a global public health issue with increasing prevalence. Chronic pain causes sleep disorder, reactive anxiety, and depression, impairs the quality of life; it burdens the individual and society as a whole. The aim of this study was to examine non-medical factors related to the outcome of the treatment of chronic non-malignant pain. METHODS: A cross-sectional study with two groups of patients was conducted using a questionnaire with biological, psychological, and social characteristics of patients. Since this study was cross-sectional, it was not possible to determine whether some factors were the cause or the consequence of unsuccessful treatment outcome, which is at the same time one of the disadvantages of cross-sectional studies. RESULTS: The poor outcome of the treatment of chronic non-malignant pain in a multivariate binary logistic regression model was statistically significantly associated with the lower quality of life (OR = 0.95 (95% CI: 0.91-0.99; p = 0.009), and higher depression level OR = 1.08 (95% CI: 1.02-1.14; p = 0.009). The outcome of the treatment was not directly related to social support measured by the multivariate binary logistic regression model (OR = 1.04, 95% CI: 0.95-1.15, p = 0.395), but solitary life (without partner) was (OR = 2.16 (95% CI: 1.03-4.53; p = 0.043). CONCLUSION: The typical patient with a poor pain management outcome is retired, presents depressive behavior; their pain disturbs general activity and sleeping. Moreover, they have a physically disturbed quality of life and require self-treatment due to the inaccessibility of doctors and therapies. The principle of treatment of patients with chronic, non-malignant pain should take into account a biopsychosocial approach with individually adjusted procedures.

Involvement of relatives in chronic non-malignant pain rehabilitation at multidisciplinary pain centres: part one - the patient perspective.

OBJECTIVES: Chronic non-malignant pain (CNP) is a significant healthcare problem with considerable consequences for patients, relatives and society. CNP is a lifelong condition that calls for acceptance and self-management. Existing research indicates that the involvement of relatives improves patients' and relatives' management of CNP, but the area is, at present, scarcely described. Research is required to obtain knowledge about the patients' experiences, needs and preferences concerning the involvement of their relatives within the frame of CNP rehabilitation, which is the aim of this study. METHODS: The study applied a qualitative phenomenological-hermeneutic design conducting individual interviews with 10 patients with CNP from three selected Multidisciplinary Pain Centres (MPC). The analysis was guided by Paul Ricoeur's philosophy of interpretation of the text. RESULTS: The findings illuminated the patients' perspectives on the involvement of relatives within three key themes, each having two or three sub-themes. The analysis revealed that patients in CNP rehabilitation had various interpretations of the substance of involving relatives, reflecting their sparse experiences. It seemed arbitrary, who during the rehabilitation actually experienced the involvement of their relatives, leaving the impression of an area short of structure. This shortage was troublesome, due to a heartrending impact of CNP. Patients' reduced functional level, combined with their surroundings difficulties in grasping the magnitude of CNP led to a loss of relationships and a risk of social isolation. Patients' close relationships became essential but were under pressure as well. Patients living with a spouse/cohabitant experienced that the relationship was affected by a disrupted balance and pain-related emotional outbursts. The patients experienced a profound need for being understood, but the text also revealed a need for mutual understanding to acknowledge the relatives' strain as well. Particular patients with children living at home experienced to be under great strain, complicated by a deep concern for long-term consequences for their children growing up influenced by parental CNP. Experienced involvement of relatives, even to a minor extend was perceived as beneficial for the patients, who experienced increased understanding and support from the relatives. However, due to the lack of a structured service, the patients' access to the involvement of relatives became dependent on their ability to define their need and pick it out. Thus the patients also expressed a general preference for mandatory and structured involvement, yet tailored to the specific patient. CONCLUSIONS: The study showed an overwhelming need for the involvement of relatives among patients with CNP, indicating that increased attention and investigation of relevant interventions are required. Despite differences between the MPC, our primary impression was that the involvement of relatives reached a minimal level of what was expected, which might entail desertion of patients scarce of resources. Individualised adjusted involvement of relatives is assumed to improve patient's management of CNP in everyday life. A family systems nursing (FSN) approach is a relevant proposal for intervention, useful in other illness areas. Still, research needs to shed light on the appropriateness of FSN when involving relatives in the rehabilitation of CNP.

Current status of opioid epidemic in the United Kingdom and strategies for treatment optimisation in chronic pain.

The increase in opioid prescriptions in the United States has been accompanied by an increase in misuse as well as overdose and toxicity related morbidity and mortality. However, the extent of the increased opioid use, including misuse in the United Kingdom, currently remains less debated. Recent studies in the United Kingdom have shown a rise in opioid use and attributed deaths, particularly in areas with higher deprivation. There are also large variations amongst the devolved nations; Scotland has the highest drug-related deaths and year-on-year increase within Europe. Better clinical guidelines that can enable person-centred management of chronic pain, medicines optimisation, and early diagnosis and treatment of opioid use disorder are crucial to addressing opioid-related morbidity and mortality in the United Kingdom.

Experiences of people taking opioid medication for chronic non-malignant pain: a qualitative evidence synthesis using meta-ethnography.

OBJECTIVE: To review qualitative studies on the experience of taking opioid medication for chronic non-malignant pain (CNMP) or coming off them. DESIGN: This is a qualitative evidence synthesis using a seven-step approach from the methods of meta-ethnography. DATA SOURCES AND ELIGIBILITY CRITERIA: We searched selected databases-Medline, Embase, AMED, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science and Scopus (Science Citation Index and Social Science Citation Index)-for qualitative studies which provide patients' views of taking opioid medication for CNMP or of coming off them (June 2017, updated September 2018). DATA EXTRACTION AND SYNTHESIS: Papers were quality appraised using the Critical Appraisal Skills Programme tool, and the GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation working group - Confidence in Evidence from Reviews of Qualitative research) guidelines were applied. We identified concepts and iteratively abstracted these concepts into a line of argument. RESULTS: We screened 2994 unique citations and checked 153 full texts, and 31 met our review criteria. We identified five themes: (1) reluctant users with little choice; (2) understanding opioids: the good and the bad; (3) a therapeutic alliance: not always on the same page; (4) stigma: feeling scared and secretive but needing support; and (5) the challenge of tapering or withdrawal. A new overarching theme of 'constantly balancing' emerged from the data. CONCLUSIONS: People taking opioids were constantly balancing tensions, not always wanting to take opioids, and weighing the pros and cons of opioids but feeling they had no choice because of the pain. They frequently felt stigmatised, were not always 'on the same page' as their healthcare professional and felt changes in opioid use were often challenging. TRIAL REGISTRATION NUMBER: 49470934; Pre-results.

Cognitive Function During Opioid Tapering in Patients with Chronic Pain: A Prospective Cohort Study.

PURPOSE: Evidence for efficacy and safety lacks for long-term opioid therapy in patients with chronic non-cancer pain and adverse effects, including affection of cognitive function and quality of life, is of concern. We aimed to investigate cognitive function and health-related quality of life in patients with chronic non-cancer pain during opioid reduction. PATIENTS AND METHODS: At two multidisciplinary pain centers, all patients with planned opioid reduction were screened for eligibility. Cognitive function was assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Trail Making Test A and B. Health-related quality of life was assessed using Short Form-36 (SF36) and Hospital Anxiety and Depression Scale (HADS). RESULTS: We included 51 participants and 40 participants attended follow-up of median 254 (IQR 106-357) days. Baseline RBANS score was 82 (IQR 65-93) with reference population norm value of 100 (SD±15). Daily opioid consumption was reduced from median 80 (IQR 45-161) oral morphine milligram equivalents to 19 (IQR 0-60) mg. RBANS score estimate increased by 6.2 (95% CI 3.1-9.3, p=0.0004) points after tapering. No differences were observed for Trail Making Test times, HADS or SF36 scores. CONCLUSION: Generally, cognitive function showed minor improvement after opioid tapering with stationary health-related quality of life, depression and anxiety scores. The clinical significance is unclear, as no minimal clinically important difference in RBANS score is available.

Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain.

INTRODUCTION: The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may have brought about change through the experiences of the participants receiving and the staff delivering the intervention and whether there were contextual factors involved. METHODS AND ANALYSIS: A mixed methods process evaluation will assess how the processes of the I-WOTCH intervention fared and whether these affected the outcomes. We will collect quantitative data, for example, group attendance analysed with statistical methods. Qualitative data, for example, from interviews and feedback forms will be analysed using framework analysis. We will use a 'following a thread' and a mixed methods matrix for the final integrated analysis. ETHICS AND DISSEMINATION: The I-WOTCH trial and process evaluation were granted full ethics approval by Yorkshire and The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). All data were collected in accordance with data protection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written informed consent. The results of the process evaluation will be published and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN49470934; Pre-results.

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.

Prolonged release oxycodone and naloxone treatment counteracts opioid-induced constipation in patients with severe pain compared to previous analgesic treatment.

OBJECTIVE: Treatment with prolonged-release oxycodone/naloxone (PR OXN) has been shown to improve opioid induced constipation (OIC) in constipated patients. This publication reports on a real-life observational study investigating the efficacy of PR OXN with regard to bowel function in patients switching to PR OXN from WHO step 1, step 2 and step 3 opioids. METHODS: Patients with chronic pain experiencing insufficient pain relief and/or unacceptable side effects were switched to PR OXN and monitored in this observational study with respect to efficacy regarding bowel function and efficacy regarding pain relief in comparison with previous analgesic therapy. A patient was considered a responder with respect to efficacy if this assessment was "slightly better", "better" or "much better" compared with previous therapy. Bowel function index, pain intensity, quality of life, laxative medication use, and safety analgesic were also evaluated. RESULTS: A total of 1338 patients (mean [SD] age 64.3 [14.9], 63% female) were observed for 43 [3-166] days (median [range]) during treatment with PR OXN. Overall response rate regarding bowel function efficacy was 82.5%. Patients with symptoms of constipation at study entry obtained a clinically relevant improvement of the bowel function index (BFI) within the first 2 weeks of PR OXN treatment. Non-constipated patients at study entry maintained normal bowel function despite switching to treatment with the opioid PR OXN. CONCLUSION: In conclusion, treatment with PR OXN results in a significant and clinically relevant improvement of bowel function. During the observation of the treatment with PR OXN patients reported an improvement of quality of life (QoL). More interestingly, non-constipated patients maintained a normal bowel function, showing prevention of constipation despite the use of an opioid.

The Pain Experience of Hispanic Americans: A Critical Literature Review and Conceptual Model.

UNLABELLED: Although the Hispanic population is a burgeoning ethnic group in the United States, little is known about their pain-related experience. To address this gap, we critically reviewed the existing literature on pain experience and management among Hispanic Americans (HAs). We focused our review on the literature on nonmalignant pain, pain behaviors, and pain treatment seeking among HAs. Pain management experiences were examined from HA patients' and health care providers' perspectives. Our literature search included variations of the term "Hispanic" with "AND pain" in PubMed, Embase, Web of Science, ScienceDirect, and PsycINFO databases. A total of 117 studies met our inclusion criteria. We organized the results into a conceptual model with separate categories for biological and/or psychological and sociocultural and/or systems-level influences on HAs' pain experience, response to pain, and seeking and receiving pain care. We also included information on health care providers' experience of treating HA patients with pain. For each category, we identified future areas of research. We conclude with a discussion of limitations and clinical implications. PERSPECTIVE: In this critical review of the literature we examined the pain and management experiences of the HA population. We propose a conceptual model, which highlights findings from the existing literature and future areas of research.

An exploration of opioid medication management for non-malignant pain in primary care.

The present study aimed to explore how prescription of opioid medication for chronic non-malignant pain (CNMP) is managed in primary care. We used audit as a research tool, and one general practitioner (GP) practice in West London acted as an exemplar. Of the practice population with CNMP, 1% had repeat prescription of at least 12 months duration for opioid analgesics at the time of data collection. These 1% are on highly controlled opioids. Our study showed the following: (1) long-term opioid prescription appears to follow a fluctuating course as opposed to staying the same; (2) we found that medication reviews were done in most cases (85.7%), but the quality of the process is difficult to assess and ascertain; and (3) we identified two incidences where opioid contract was implemented. In both cases, contracts were used as a last chance warning for patients who were already problematic, suggesting that opioid contracts served as a disciplinary tool rather than a preventative measure. Our findings highlight a need for a more structured and specific review of analgesic medication, and a need for a simple and effective way to identify patients at high risk of developing problematic use, to ensure better monitoring and early presentations.