Acceptability of multimodal and multidisciplinary group-based program for chronic low back pain: a qualitative study.

BACKGROUND: The Programa d'Atenció Integral pels Pacients amb Dolor Crònic (PAINDOC) is a multimodal and multidisciplinary group-based program that integrates pain neuroscience education, mindfulness meditation, pain psychotherapy, Empowered Relief, and therapeutic exercise. It serves as a therapeutic option for individuals with chronic low back pain, providing them with comprehensive adaptive strategies for pain management. OBJECTIVE: This qualitative study explores participants' retrospective acceptability of the PAINDOC Program. METHODS: To ensure demographic variability and information power, a purposive sampling approach was applied. Twelve participants were interviewed through three focus groups, supplemented with four individual semi-structured interviews. Data was analyzed using reflexive thematic analysis and evaluated based on the Therapeutic Framework of Acceptability. RESULTS: Participants provide positive feedback regarding active pain coping strategies and improved self-management. While certain aspects of the Program were more emphasized, participants integrated tools from all components. Strategies included pain reconceptualization, positive self-talk, or problem-solving. The Program's ethicality was closely linked to individual values and may also be influenced by time constraints of certain program elements, the immediate effects of specific approaches, participant perceptions, and individual preferences. CONCLUSIONS: The findings provide valuable insights into the acceptability of the PAINDOC Program, guiding future improvements and the development of similar interventions.

Multidisciplinary approaches to chronic pain management have been explored and are recognized as an effective way to address the complexity of chronic pain conditions. These approaches often involve the collaboration of healthcare professionals from various disciplines.Multimodal pain management programs typically combine various treatment modalities, including physical therapy, cognitive-behavioral therapy, medication, and exercise.Studies have shown that multidisciplinary and multimodal interventions can be effective in reducing pain intensity, improving physical function, and enhancing quality of life in chronic low back pain patients. What does this study add? The multidisciplinary and multimodal group-based PAINDOC Program is acceptable for chronic low back pain patients.Participants noted the effectiveness of the program in helping them adopt active pain coping strategies and improve self-management.The ethicality of the multimodal Program depends on individual personal value systems, as certain program components may be less suitable for some participants.There might be some barriers to program adherence, including limited available time, the higher physical demands of exercise, the immediate effects of certain approaches, participants' perceptions, and individual needs and preferences.

Palliative Care Costs in Different Ambulatory-Based Settings: A Systematic Review.

BACKGROUND: Cost-of-illness studies in palliative care are of growing interest in health economics. There is no standard methodology to capture direct and non-direct healthcare and non-healthcare expenses incurred by health services, patients and their caregivers in the course of the ambulatory palliative care process. OBJECTIVE: We aimed to describe the type of healthcare and non-healthcare expenses incurred by patients with cancer and non-cancer patients and their caregivers for palliative care in ambulatory-based settings and the methodology used to capture the data. METHODS: We conducted a systematic review of studies on the costs of ambulatory-based palliative care in patients with cancer (breast, lung, colorectal) and non-cancer conditions (chronic heart failure, chronic obstructive pulmonary disease, dementia) found in six bibliographic databases (PubMed, EMBASE [via Ovid], Cochrane Database of Systematic Reviews, EconLit, the National Institute for Health Research Health Technology Assessment Database and the National Health Service Economic Evaluation Database at the University of York, and Google Scholar). The studies were published between January 2000 and December 2022. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology for study selection and assessed study quality using the Quality of Health Economic Studies instrument. The study was registered in PROSPERO (CRD42021250086). RESULTS: Of 1434 identified references, 43 articles met the inclusion criteria. The primary data source was databases. More than half of the articles presented data from public healthcare systems (65.12%) were retrospective (60.47%), and entailed a bottom-up costing analysis (93.2%) made from a healthcare system perspective (53.49%). The sociodemographic characteristics of patients and families/caregivers were similar across the studies. Cost outcomes reports were heterogeneous; almost all of the studies collected data on direct healthcare costs (97.67%). The main driver of costs was inpatient care (55.81%), which increased during the end-of-life period. Nine studies (20.97%) recorded costs due to productivity losses for caregivers and three recorded such costs for patients. Caregiving costs were explored through an opportunity cost analysis in all cases, based on interviews conducted with and questionnaires administered to patients and caregivers, mainly via telephone calls (23.23%). CONCLUSIONS: This systematic review reveals that studies on the costs of ambulatory-based palliative care are increasing. These studies are mostly conducted from a healthcare system perspective, which leaves out costs related to patients'/caregivers' economic burden. There is a need for prospective studies to assess this financial burden and evaluate, with strong evidence, the interventions and actions designed to improve the quality of life of palliative care patients. Future studies should propose cost calculation approaches using a societal perspective to better estimate the economic burden imposed on patients in ambulatory-based palliative care.

Risk Prescriptions of Strong Opioids in the Treatment of Chronic Non-Cancer Pain by Primary Care Physicians in Catalonia: Opicat Padris Project.

The prescription of strong opioids (SO) for chronic non-cancer pain (CNCP) is steadily increasing. This entails a high risk of adverse effects, a risk that increases with the concomitant prescription of SO with central nervous system depressant drugs and with the use of SO for non-recommended indications. In order to examine this concomitant risk prescription, we designed a descriptive, longitudinal, retrospective population-based study. Patients aged ≥15 years with a continued SO prescription for ≥3 months during 2013-2017 for CNCP were included. Of these, patients who had received concomitant prescriptions of SO and risk drugs (gabapentinoids, benzodiazepines and antidepressants) and those who had received immediate-release fentanyl (IRF) were selected. The study included 22,691 patients; 20,354 (89.7%) patients received concomitant risk prescriptions. Men and subjects with a higher socioeconomic status received fewer concomitant risk prescriptions. Benzodiazepines or Z-drugs were prescribed concomitantly with SO in 15,883 (70%) patients, antidepressants in 14,932 (65%) and gabapentinoids in 11,267 (49%), while 483 (21.32%) patients received IRF (2266 prescriptions in total) without a baseline SO. In conclusion, our study shows that a high percentage of patients prescribed SO for CNCP received concomitant prescriptions with known risks, as well as IRF for unauthorized indications.

Trends in the Prescription of Strong Opioids for Chronic Non-Cancer Pain in Primary Care in Catalonia: Opicat-Padris-Project.

In chronic non-cancer pain (CNCP), evidence of the effectiveness of strong opioids (SO) is very limited. Despite this, their use is increasingly common. To examine SO prescriptions, we designed a descriptive, longitudinal, retrospective population-based study, including patients aged ≥15 years prescribed SO for ≥3 months continuously in 2013-2017 for CNCP in primary care in Catalonia. Of the 22,691 patients included, 17,509 (77.2%) were women, 10,585 (46.6%) were aged >80 years, and most had incomes of <€18,000 per year. The most common diagnoses were musculoskeletal diseases and psychiatric disorders. There was a predominance of transdermal fentanyl in the defined daily dose (DDD) per thousand inhabitants/day, with the greatest increase for tapentadol (312% increase). There was an increase of 66.89% in total DDD per thousand inhabitants/day for SO between 2013 (0.737) and 2017 (1.230). The mean daily oral morphine equivalent dose/day dispensed for all drugs was 83.09 mg. Transdermal fentanyl and immediate transmucosal release were the largest cost components. In conclusion, there was a sustained increase in the prescription of SO for CNCP, at high doses, and in mainly elderly patients, predominantly low-income women. The new SO are displacing other drugs.

Characteristics and influence on quality of life of new-onset pain in critical COVID-19 survivors.

BACKGROUND: Pain is a clinical feature of COVID-19, however, data about persistent pain after hospital discharge, especially among ICU survivors is scarce. The aim of this study was to explore the incidence and characteristics of new-onset pain and its impact on Health-Related Quality of Life (HRQoL), and to quantify the presence of mood disorders in critically ill COVID-19 survivors. METHODS: This is a preliminary report of PAIN-COVID trial (NCT04394169) presenting a descriptive analysis in critically ill COVID-19 survivors, following in person interview 1 month after hospital discharge. Pain was assessed using the Brief Pain Inventory, the Douleur Neuropathique 4 questionnaire and the Pain Catastrophizing Scale. HRQoL was evaluated with the EQ 5D/5L, and mood disorders with the Hospital Anxiety and Depression Scale (HADS). RESULTS: From 27 May to 19 July 2020, 203 patients were consecutively screened for eligibility, and 65 were included in this analysis. Of these, 50.8% patients reported new-onset pain; 38.5% clinically significant pain (numerical rating score ≥3 for average pain intensity); 16.9% neuropathic pain; 4.6% pain catastrophizing thoughts, 44.6% pain in ≥2 body sites and 7.7% widespread pain. Patients with new-onset pain had a worse EQ-VAS and EQ index value (p < 0.001). Pain intensity was negatively correlated to both the former (Spearman ρ: -0.546, p < 0.001) and the latter (Spearman ρ: -0.387, p = 0.001). HADS anxiety and depression values equal or above eight were obtained in 10.8% and 7.7% of patients, respectively. CONCLUSION: New-onset pain in critically ill COVID-19 survivors is frequent, and it is associated with a lower HRQoL. Trial registration No.: NCT04394169. Registered 19 May 2020. https://clinicaltrials.gov/ct2/show/NCT04394169. SIGNIFICANCE: A substantial proportion of severe COVID-19 survivors may develop clinically significant persistent pain, post-intensive care syndrome and chronic ICU-related pain. Given the number of infections worldwide and the unprecedented size of the population of critical illness survivors, providing information about the incidence of new-onset pain, its characteristics, and its influence on the patients' quality of life might help establish and improve pain management strategies.

Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial.

BACKGROUND: Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge. METHODS: The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm). DISCUSSION: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic. TRIAL REGISTRATION: This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors' institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov ( NCT04394169 ).

Conditioned pain modulation predicts persistent pain after knee replacement surgery.

INTRODUCTION: Persistent pain after total knee replacement is an underestimated outcome leading to significant health burden. Sensory testing has been explored to help surgeons in decision making and better patient selection. Patients with different chronic pain syndromes exhibit a poor descending pain inhibition that can be quantified through experimental paradigms (conditioned pain modulation). A poor preoperative descending pain inhibition response predicted persistence of pain after surgery in previous studies. METHODS: This study investigated the correlation between a preoperative inefficient endogenous analgesia and a bad postoperative pain outcome (painful prosthesis). One hundred forty-six patients were studied preoperatively by quantitative sensory testing. Conditioned pain modulation was calculated as the relative decrease in pain intensity (thermal stimulus) during heterotopic painful stimulation. RESULTS: Approximately 21.2% of patients had a bad pain outcome (painful prosthesis), 6 months after surgery. Preoperatively, 47.9% of patients exhibited an insufficient endogenous analgesia. The probability to develop persistent pain after surgery in that group was higher than that in patients with a sufficient endogenous analgesia (31.4% [20.9-43.6, 95% CI] vs 11.8% [5.5-21.3, 95% CI], respectively; P < 0.004). Correlation between conditioned pain modulation values and postoperative intensity of pain was also established. Besides, a preoperative lower quality of life (mental component) predicted a worse pain outcome, too. CONCLUSIONS: This cohort study shows that preoperative sensory testing predicts a bad pain outcome after total knee replacement. This tool could help clinicians in a better indication of patients with advanced knee osteoarthritis for replacement surgery. REGISTRATION DETAILS: ClinicalTrials.gov: NCT01811888 (prospective).

Assessment of diagnostic criteria for the identification of central sensitization in patients with osteoarthritis pain: Results from a Delphi survey.

ABSTRACT: To assess diagnostic criteria and currently used tools for the identification of central sensitization (CS) in patients with joint pain due to osteoarthritis (OA).Qualitative, cross-sectional and multicenter study based on a 2-round Delphi surveyPublic and private medical centers attending patients with joint pain.A total of 113 specialists in traumatology, physical medicine and rehabilitation, pain management, rheumatology, primary care physicians and geriatrics were enrolled in the study.Participants completed an ad-hoc 26-item questionnaire available from a microsite in Internet.The questionnaire was divided into 6 sections with general data on CS, impact of CS in patients with knee osteoarthritis (KOA), diagnostic criteria for CS, non-pharmacological and pharmacological treatment of CS and usefulness of the concept of CS in the integral management of patients with KOA. Consensus was defined as 75% agreement.Diagnostic criteria included pain of disproportionate intensity to the radiological joint lesion (agreement 86.7%), poor response to usual analgesics (85.8%), progression of pain outside the site of the lesion (76.1%) and concurrent anxiety and depression (76.1%). Based on the opinion of the specialists, about 61% of patients with KOA present moderate-to-severe pain, 50% of them show poor response to conventional analgesics, and 40% poor clinical-radiological correlation. Patients with KOA and CS showed higher functional disability and impairment of quality of life than those without CS (88.5%) and have a poor prognosis of medical, rehabilitation and surgical treatment (86.7%). Early diagnosis and treatment of CS may preserve function and quality of life during all steps of the disease (90.3%).The management of patients with osteoarthritis pain and CS requires the consideration of the intensity of pain related to the joint lesion, response to analgesics, progression of pain to other areas and concurrent anxiety and depression to establish an adequate therapeutic approach based on diagnostic criteria of CS.

Synergistic interaction between dexamethasone and tramadol in a murine model of acute visceral pain.

Tramadol is effective in the management of mild to moderate postoperative pain, but its administration is associated with nausea and vomiting. Patients treated with tramadol, often receive dexamethasone as antiemetic. The aim of our investigation was to assess if the two drugs interact in a murine model of acute visceral pain. Using the acetic acid writhing test in mice, we assessed the antinociceptive effects of tramadol and dexamethasone (a glucocorticoid with antiemetic effect) administrated individually and in a 1 : 1 fixed ratio combination. Tramadol and dexamethasone induced a dose-dependent inhibition of the writhing response when administered individually, with ED(50) values of 2.9 [2.09-4.31, 95% confidence limit (CL)] mg/kg, and 0.13 (0.05-0.29, 95% CL) mg/kg, respectively. The ED(50) of the combination was 0.13 (0.01-0.29, 95% CL) mg/kg; the isobolographic and interaction index analysis revealed a synergistic interaction. The results suggest that the combination of tramadol and dexamethasone could be beneficial in the management of postoperative pain in humans.

Dexketoprofen-induced antinociception in animal models of acute pain: synergy with morphine and paracetamol.

The antinociceptive activity of dexketoprofen was studied in mice using the acetic acid writhing test (acute tonic pain), the tail flick test (acute phasic pain) and the formalin assay (inflammatory pain). Isobolographic analysis was used to study the antinociceptive interactions between morphine and paracetamol co-administered with dexketoprofen. In the writhing test, the intraperitoneal administration of dexketoprofen or ketoprofen resulted in parallel dose-response curves with equal efficacy, but higher relative potency for dexketoprofen. In the tail flick test, the curves were parallel with similar efficacy and potency. The administration of morphine or paracetamol in both tests resulted in dose-response curves not parallel with that of dexketoprofen, which showed a potency between morphine and paracetamol. In the formalin assay, the antinociceptive activity of morphine during phase I was 122, 295 and 1695 times higher than dexketoprofen, ketoprofen and paracetamol, respectively. Isobolographic analysis demonstrated that the combination of sub-analgesic doses of dexketoprofen with morphine or with paracetamol was strongly synergic in all three tests. Synergistic drug combinations should improve effective pharmacological treatment of pain, minimizing drug specific adverse effects. These findings are undoubtedly worthy of additional controlled clinical trials in severe pain syndromes.

Interaction between tramadol and two anti-emetics on nociception and gastrointestinal transit in mice.

BACKGROUND: Clinical studies suggest that tramadol-induced analgesia is partially antagonized by ondansetron. AIMS: To investigate the type of interaction between tramadol and two anti-emetics on antinociception and gastrointestinal transit in mice. METHODS: We assessed the antinociceptive (acetic acid writhing test, plantar test) and antitransit (charcoal meal) effects of tramadol individually, and combined with ondansetron or droperidol in female Swiss CD-1 mice. Isobolograms and analysis of variance were used to determine the type of interaction. RESULTS: In the writhing test, tramadol, ondansetron and droperidol, each induced dose-related inhibition of nociception. The ED(50)'s were: tramadol 4.2+/-0.33 mg kg(-1); ondansetron 1.03+/-0.05 mg kg(-1), and droperidol 1.00+/-0.14 mg kg(-1). Dose-response curves were also obtained with tramadol combined with ondansetron or droperidol at 1:1 fixed ratios. The isobolographic analysis demonstrated antagonism for both combinations. In the plantar test, the ED(50) for tramadol was 51.4+/-2.3 mg kg(-1), but no dose-response curves could be obtained with ondansetron or droperidol individually. The interaction was assessed from dose-response curves to tramadol in the presence of a fixed dose of ondansetron (0.1 mg kg(-1)) or droperidol (0.05 mg kg(-1)). The results show antagonism between tramadol-ondansetron (p<0.05) and no interaction for the tramadol-droperidol combination. Both anti-emetics antagonized the antitransit effects of tramadol. CONCLUSIONS: The interaction of tramadol with ondansetron or droperidol on antinociception can be antagonistic or additive, depending on the type of stimuli. Both anti-emetics antagonize the anti-transit effects of tramadol. The results demonstrate antagonism between tramadol and the two anti-emetics for analgesia and inhibition of gastrointestinal transit, supporting previous clinical studies.