Longitudinal Resilience and Risk Factors in Pediatric Postoperative Pain (LORRIS): Protocol for a Prospective Longitudinal Swiss University Children's Hospitals-Based Study.

INTRODUCTION: Chronic postsurgical pain (CPSP) is defined as pain that persists after a surgical procedure and has a significant impact on quality of life. Previous studies show the importance of psychological factors in CPSP, yet the majority of studies focused solely on negative emotions. This longitudinal observational study aims to broaden this knowledge base by examining the role of emotional state, emotion variability, emotion regulation and emotion differentiation on the child and the parent level for the development CPSP, and to describe pain and emotion-related trajectories following surgery. METHODS AND ANALYSIS: We intend to include 280 children and adolescents aged 8-18 years with a planned orthopaedic surgery and their parents. A total of five assessment time points is planned: 3 weeks before surgery (baseline), 2 weeks after surgery (post) and 3 months (follow-up (FU) 1), 6 months and 12 months after surgery. At baseline and post only, children and parents are asked to complete a daily diary thrice a day for a week where they rate their current emotional state and their pain severity (children only). Emotional state ratings will be used to calculate indices of emotion variability, emotion regulation and emotion differentiation. Children and parents will complete questionnaires at each time point, including measures on quality of life, social support, sleep, and symptoms of anxiety and depression.To predict development of CPSP, generalised linear regression models will be used, resulting in ORs and 95% CIs. Pearson product-moment correlations between predictors and outcomes will be evaluated at each time point. The primary outcome of the prediction model is CPSP at FU1. For the trajectory analysis, the classification method K-means for longitudinal data will be used to determine clusters in the data. ETHICS AND DISSEMINATION: The Ethics Committee of the Canton of Zurich, Switzerland, has approved the study (ID: 2023-01475). Participants will be compensated, and a dissemination workshop will be held. TRIAL REGISTRATION NUMBER: NCT05816174.

Body reprogramming for fibromyalgia and central sensitivity syndrome: A preliminary evaluation.

Objectives: Central sensitivity syndrome disorders such as fibromyalgia, provoke continued debate, highlighting diagnostic and therapeutic uncertainty. The Hyland model provides a way of understanding and treating the medically unexplained symptoms of central sensitivity syndromes using complexity theory and principles of adaption in network systems. The body reprogramming is a multi-modal intervention based on the Hyland model designed for patients living with medically unexplained symptoms. This preliminary, naturalistic and single-arm service evaluation set out to evaluate outcome after attending a body reprogramming course in patients living with fibromyalgia or central sensitivity syndrome. Methods: Patients diagnosed with fibromyalgia or central sensitivity syndrome were recruited. The body reprogramming courses consisting of eight sessions, each 2.5 h in length, were run at two study sites in England. Data were collected at baseline, post course and 3-months post course using questionnaires assessing symptomatology (FIQR/SIQR), Depression (PHQ9), Anxiety (GAD7) and quality of life (GQoL). Repeated measures t-tests were used, and all comparisons were conducted on an intention to treat basis. Results: In total, 198 patients with a mean age of 47.73 years were enrolled on the body reprogramming courses. Statistically and clinically significant improvement were observed in the FIQR from baseline to post course (mean change: 11.28) and baseline to follow-up (mean change: 15.09). PHQ9 scores also improved significantly from baseline to post course (mean reduction 3.72) and baseline to follow-up (mean reduction 5.59). Conclusions: Our study provides first evidence that the body reprogramming intervention is an effective approach for patients living with fibromyalgia or central sensitivity syndromes on a variety of clinical measures. Besides these promising results, important limitations of the study are discussed, and larger randomized controlled trials are clearly warranted.

Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial.

Introduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatment of acute postoperative pain, minimization of opioid related side effects remains one of the key challenges. Therefore, this study aims at investigating the potential of adding unconditioned open-label placebos to treatment as usual as a means of reducing opioid consumption and its related side effects in patients with acute postoperative pain. Methods and Analysis: This is the protocol of an ongoing single site randomized controlled trial. The first patient was enrolled in May 2020. In total, 70 patients suffering from acute postoperative pain following dorsal lumbar interbody fusion are randomized to either a treatment as usual group or an experimental intervention group. The treatment as usual group consists of participants receiving a patient-controlled morphine pump. On day 1 and 2 post-surgery, patients in the intervention group receive, in addition to treatment as usual, two open-label placebo injections per day along with an evidence-based treatment rationale explaining the mechanisms of placebos. The primary outcome is measured by means of self-administered morphine during day 1 and 2 post-surgery. Several other outcome measures including pain intensity and adverse events as well as potential predictors of placebo response are assessed. Analysis of covariance will be used to answer the primary research question and additional statistical techniques such as generalized linear mixed models will be applied to model the temporal course of morphine consumption. Discussion: This study will provide valuable insights into the efficacy of open-label placebos in acute pain and will potentially constitute an important step toward the implementation of open-label placebos in the clinical management of acute postoperative pain. In addition, it will shed light on a cost-efficient and patient-centered strategy to reduce opioid consumption and its related side effects, without any loss in pain management efficacy. Ethics and Dissemination: The "Ethikkommission Nordwest- und Zentralschweiz" (BASEC2020-00099) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal. Clinical Trial Registration: The study is registered at ClinicalTrials.gov (NCT04339023) and is listed in the Swiss national registry at kofam.ch (SNCTP000003720).

Treating Pain With Open-Label Placebos: A Qualitative Study With Post-Surgical Pain Patients.

Prior research has shown that Open Label Placebos (OLPs; that is, placebos described honestly as inactive pills) are effective for a variety of clinical conditions, including pain. However, little is known about patient attitudes towards OLPs. We conducted qualitative interviews with n = 11 patients (73% female) who recently had hand or wrist surgery and took ≥ 1 opioid pill. Interview topics included: pain management, the placebo effect, and in particular, attitudes towards OLPs. Interviews were analyzed inductively and content-coded. Five themes were identified: 1) Role of the mind in pain and illness, 2) Shortcomings of opioids are the strengths of OLPs, 3) Perceptions of OLP effectiveness, 4) Relational aspects of OLP administration, and 5) Practical considerations for OLP implementation. Most patients agreed that, because of their transparency, OLPs are ethical. Participants indicated some degree of reluctance about using OLPs, but the majority said they would take OLPs if prescribed by a doctor. Patients noted that the primary disadvantage of opioids is their potency, which can lead to addiction or side-effects; by contrast, the primary advantage of placebos is their inertness. Results suggest that OLPs appear to be well received as a postoperative pain treatment among the patients in this study. PERSPECTIVE: This qualitative study examines how hand surgery patients view OLPs, which are placebos described honestly as inactive pills. OLPs were generally well received by patients as a treatment for pain after surgery and could be considered as an adjunctive treatment to potentially reduce reliance on prescription opioids.

Placebo Responses and Their Clinical Implications in Fibromyalgia: A Meta-Analysis Using SSRI and SNRI Trials.

Background: Fibromyalgia (FM) is a chronic primary pain condition, associated with widespread musculoskeletal pain, disturbed sleep, fatigue, cognitive dysfunction, and a range of comorbid conditions such as irritable bowel syndrome, and depression. Despite its high prevalence of 2% in the general population, FM continues to pose scientific and clinical challenges in definition, etiology, and day-to-day management. In terms of treatment, FM can be treated with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs). Objective: Patients with FM and other chronic primary pain syndromes are known to experience substantial and clinically relevant placebo effects. An update of the placebo responses for various outcomes in the FM population and especially a discussion about clinical implications is therefore needed. Methods: We used data from a large data pool that includes randomized controlled trials (RCTs) examining within-placebo mean change scores of baseline vs. follow-up assessments in FM trials of SSRIs and SNRIs. The primary outcomes were pain, functional disability, and depression and using different scales. We assessed heterogeneity of included trials. Results: A total of 29 RCTs with N = 8,453 patients suffering from FM were included in our analysis. Within-placebo mean change scores of baseline vs. follow-up assessments were large for pain (mean change = 2.31, 95% CI: 0.42-4.21, p = 0.017), functional disability (mean change = 3.31, 95% CI: 2.37-4.26, p < 0.000), and depression (mean change = 1.55, 95% CI: 0.92-2.18, p < 0.000). Heterogeneity was found to be large for all outcomes. Impact: Our results provide preliminary evidence that placebo responses, which also consist of non-specific effects, might play a role in the treatment of FM. Furthermore, we highlight limitations of our analyses and make suggestions for future studies.

Body Reprogramming: Reframing the Fibromyalgia narrative and providing an integrative therapeutic model.

We propose a theory known as the Hyland model to help conceptualise Fibromyalgia within a complex adaptive control system. A fundamental assumption is that symptom generating mechanisms are causally connected, forming a network that has emergent properties. An illness narrative has been developed which has a 'goodness of fit' with the lived experience of those with Fibromyalgia. The theory guides management within the clinical setting and incorporates current evidence-based therapeutic strategies, within a multi-modal intervention described as 'Body Reprogramming'. This intervention focuses on non-pharmacological and lifestyle-based considerations. The theoretical framework also helps explain why modest therapeutic effects are gained from current pharmacological options.