Dataset Information

NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain.

ABSTRACT:

Introduction

Pain is the second most frequent symptom reported in patients with cancer among the main reasons for consultation. The incorporation of educational modalities in pain intervention processes has been suggested. This study aims to examine the efficacy of neuroscience pain education (PNE) in relation to pain, biopsychosocial variables and functional capacity in comparison with conventional treatment. It is hypothesised that an intervention based on PNE achieves better outcomes than conventional management, in terms of pain, biopsychosocial variables and functional capacity in adults with oncological pain.

Methods and analysis

This will be a single-blind, controlled clinical trial in which two groups will be compared using changes in pain as the primary measure. The first group will receive conventional treatment in addition to PNE, and participants will undergo an intervention of nine sessions (one session per week, for a total of 9 weeks), each lasting 30-40 min. Specifically, these sessions will teach biophysiological elements using metaphors that allow the adoption of these concepts related to pain. The second group will receive conventional treatment (pharmacological treatment). For this study, a sample size calculation was made based on the background, where 80 adults with oncological pain were required. An initial evaluation will be made to establish the baseline characteristics, and then, according to the randomisation, the assignment to the PNE group or the control group will be made and the two groups will be summoned again. Ten weeks later, for the intervention evaluation, the statistical analysis plan will be established by protocol and by intention-to-treat.

Ethics and dissemination

This protocol complies with all ethical considerations. The authors commit to presenting the study's results. This study was approved by the ethics committees of the Universidad Santiago de Cali, Clínica de Occidente/Angiografía de Occidente. The authors commit to presenting the study's results.

Trial registration number

NCT05581784.

SUBMITTER: Ordonez-Mora LT

PROVIDER: S-EPMC10537834 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain.

Ordoñez-Mora Leidy Tatiana LT Rosero Ilem D ID Morales-Osorio Marco Antonio MA Guil Rocío R Quintero Jordan Giancarlo G Agudelo Jimenez Julian Alberto JA Gonzalez-Ruiz Katherine K Avila-Valencia Juan Carlos JC

BMJ open 20230927 9

<h4>Introduction</h4>Pain is the second most frequent symptom reported in patients with cancer among the main reasons for consultation. The incorporation of educational modalities in pain intervention processes has been suggested. This study aims to examine the efficacy of neuroscience pain education (PNE) in relation to pain, biopsychosocial variables and functional capacity in comparison with conventional treatment. It is hypothesised that an intervention based on PNE achieves better outcomes ...[more]

PMID: 37758676

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Project description:BackgroundPain Neuroscience Education (PNE) consists of an educational strategy that seeks to understand the biological processes of pain and how to control it. The main objective of this study will be to evaluate the impact of PNE on outcomes related to the postoperative period. The hypothesis is that the intervention may positively influence postoperative recovery, contributing to pain control, clinical indications, acceptance and consumption of analgesics and other pharmacological drugs that contribute to its control, as well as psychological aspects, such as anxiety, depression and pain catastrophising.Methods and analysisThis will be an open, parallel, multicentre and randomised controlled clinical trial. A total of 100 participants aged between 18 and 59 years of age, of both genders, who are going to have elective general surgery will be evaluated. The intervention group will participate in a preoperative pain neuroscience educational session and also receive usual preoperative care, while the control group receives usual preoperative care as well. The educational session will last 30 min and consists of a video (5:20 min), a questionnaire about the content, time for participants to express their beliefs, thoughts and doubts. Participants will be evaluated preoperatively and there will be one postintervention evaluation. The intensity and characteristics of pain and anxiety are evaluated as primary outcomes. As secondary outcomes, pain catastrophising and depression are taken into account.Ethics and disseminationThe project was approved by the Research Ethics Committee of the Faculty of Ceilandia, the Research Ethics Committee of the Institute of Strategic Health Management of the Federal District and the Research Council of the Hospital of Brasília-Rede Dasa (CAAE: 28572420.3.0000.8093). Recruitment began in June of 2023. All participants were included in the study only after their written consent. All data obtained will be analysed and distributed through publication in journals and at scientific events.Trial registration numberBrazilian Registry of Clinical Trials (ReBEC) (RBR-23mr7yy).

Project description:IntroductionOver the past decades, awareness on the importance of educational interventions in cancer pain management has increased. However, education is often restricted to biomedical pain management instructions. A more modern educational approach, also known as pain neuroscience education (PNE), explains pain from a biopsychosocial perspective. We hypothesise that this more comprehensive educational approach in the early treatment phase of breast cancer will lead to more beneficial effects for cancer pain management. Therefore, the aim of the present study is to investigate the effectiveness of this PNE intervention, in addition to best evidence physical therapy modalities for treatment and prevention of pain, physical, emotional and work-related functioning after breast cancer surgery, compared with a traditional biomedical educational intervention.MethodsA double-blinded randomised controlled trial has been started in November 2017 at the University Hospitals of Leuven. Immediately after breast cancer surgery, all participants (n=184) receive a 12-week intensive standard physical therapy programme. They receive three additional refresher sessions at 6, 8 and 12 months postsurgery. In addition, participants receive three educational sessions during the first-month postsurgery and three 'booster sessions' at 6, 8 and 12 months postsurgery. In the intervention group, the content of the education sessions is based on the modern PNE approach. Whereas in the control group, the education is based on the traditional biomedical approach. The primary outcome parameter is pain-related disability 1 year after surgery. Secondary outcomes related to other dimensions of pain, physical, emotional and work-related functioning at 1-week, 4, 6, 8, 12 and 18 months postsurgery.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals of Leuven. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses.Trial registration numberNCT03351075.

Project description:IntroductionCurrent treatments for pain in breast cancer survivors (BCSs) are mostly biomedically focused rather than biopsychosocially driven. However, 22% of BCSs with pain are experiencing perceived injustice, which is a known predictor for adverse pain outcomes and opioid prescription due to increased maladaptive pain behaviour. Educational interventions such as pain neuroscience education (PNE) are suggested to target perceived injustice. In addition, motivational interviewing can be an effective behavioural change technique. This trial aims to examine whether perceived injustice-targeted PNE with the integration of motivational interviewing is superior to biomedically focused pain education in reducing pain after 12 months in BCS with perceived injustice and pain. In addition, improvements in quality of life, perceived injustice and opioid use are evaluated, and a cost-effectiveness analysis will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in BCSs with perceived injustice and pain.Methods and analysisThis two-arm multicentre randomised controlled trial will recruit female BCS (n=156) with pain and perceived injustice. Participants will be randomly assigned to perceived injustice-targeted PNE or biomedically focused pain education in each centre. Both interventions include an online session, an information leaflet and three one-to-one sessions. The primary outcome (pain), secondary outcomes (quality of life, perceived injustice and outcomes for cost-effectiveness analysis) and explanatory outcomes (pain phenotyping, sleep, fatigue and cognitive-emotional factors) will be assessed at baseline and at 0, 6, 12 and 24 months postintervention using self-reported questionnaires online. Treatment effects over time will be evaluated using linear mixed model analyses. Additionally, a cost-utility analysis will be done from a healthcare payer and societal perspective.Ethics and disseminationThe ethical agreement was obtained from the Main Ethics Committee (B.U.N.1432020000068) at the University Hospital Brussels and all other participating hospitals. Study results will be disseminated through presentations, conferences, social media, press and journals.Trial registration numberNCT04730154.

Project description:IntroductionCancer-related chronic pain is an important sequelae that damages the quality of life of breast cancer survivors. Pain neuroscience education and graded exposure to movement are therapeutic tools that have been shown to be effective in the management of chronic pain in other populations. However, there are no previous studies that combine them after breast cancer.ObjectiveTo evaluate the effectiveness of an online physiotherapy focused-person program which combines pain neuroscience education and graded exposure to movement for quality of life improvement in breast cancer survivors.MethodologyThis protocol is a randomized controlled trial with a sample size of 40 breast cancer survivors with pain in the last 6 months. Participants will be allocated to the experimental or control group using a fixed size block randomization method. The evaluator and statistician will be blinded to participant allocation. Participants in the experimental group will receive a 12-week intervention based on pain neuroscience education and therapeutic yoga as a graded exposure to movement exercise; participants in the control group will continue with their usual cancer-related symptoms care. Both groups will receive an education booklet. The main outcome will be quality of life, measured by the Functional Assessment of Cancer Therapy - Breast (FACT-B+4); secondary, four outcomes related to pain experience (catastrophising, self-efficacy, kinesiophobia and fear-avoidance behaviors) will be also assessed. All variables will be assessed by two blinded evaluators at four timepoints. A mixed-model analyses of variance ANOVA (2 × 4) will be used to study the effects of the treatment on the dependent variables. All statistical tests will be performed considering a confidence interval of 95%. SPSS program will be used for the data analysis.DiscussionThis research is expected to contribute to breast cancer rehabilitation field. The proposed intervention is also expected to improve self-care skills related to chronic pain and to empower women regarding the management of their symptoms and quality of life.Clinical trial registration: https://clinicaltrials.gov/, NCT04965909.

Project description:BackgroundTotal knee arthroplasty (TKA) is considered an effective treatment for pain relief and improved physical performances in end-stage knee osteoarthritis. However, several studies have reported less favorable outcomes after TKA with chronic pain rates of approximately 20%. Exercise might be an effective treatment strategy for chronic pain following TKA, but no randomized controlled trials have evaluated its effect. Therefore, the purpose of this randomized controlled trial is to investigate whether a 12-week neuromuscular exercise (NEuroMuscular EXercise training program for patients with knee or hip osteoarthritis assigned for total joint replacement; NEMEX-TJR) program combined with pain neuroscience education (PNE) provides greater pain relief and improvement in physical performances than PNE alone at 12 months follow-up in a population of patients with chronic pain after primary TKA.MethodsFor this randomized controlled superiority trial, 120 patients with moderate-to-severe chronic pain after TKA are recruited from Aalborg University Hospital, Denmark. Patients are randomly assigned in a 1:1 ratio to one of two interventions: (a) NEMEX-TJR twice weekly for 12 weeks combined with two sessions of PNE or (b) two sessions of PNE given over 6 weeks. Assessment is performed at baseline before intervention and at 3, 6, and 12 months after initiation of the intervention. Outcome assessors are blinded toward group allocation. The primary outcome is the change in the Knee Injury and Osteoarthritis Outcome Score4 (KOOS4), defined as the mean score for the KOOS subscales pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include all KOOS subscale scores and scores for PainDETECT, the Fear-Avoidance Beliefs Questionnaire, Global Perceived Effect, the Pain Catastrophizing Scale, pain intensities, temporal summation, conditioned pain modulation, and pressure pain thresholds. Physical performances are measured with walking, stair climbing, and chair standing tests as well as tests of muscle strength and power.DiscussionThe findings will be useful in establishing effective treatment strategies for chronic pain after TKA. The randomized controlled trial involves rigorous scientific methods and uses clinically applicable interventions. The study interventions are conducted in clinical settings, thereby enhancing the possibility of future implementation of the treatments in the health care systems.Trial registrationClinicalTrials.gov identifier: NCT03886259. Registered 22 March 2019. Ethics committee registration: N-20180046.

Project description:IntroductionPeople experiencing homelessness suffer from poor outcomes after hospitalisation due to systemic barriers to care, suboptimal transitions of care, and intersecting health and social burdens. Case management programmes have been shown to improve housing stability, but their effects on broad posthospital outcomes in this population have not been rigorously evaluated. The Navigator Programme is a Critical Time Intervention case management programme that was developed to help homeless patients with their postdischarge needs and to link them with community-based health and social services. This randomised controlled trial examines the impact of the Navigator Programme on posthospital outcomes among adults experiencing homelessness.Methods and analysisThis is a pragmatic randomised controlled trial testing the effectiveness of the Navigator Programme at an urban academic teaching hospital and an urban community teaching hospital in Toronto, Canada. Six hundred and forty adults experiencing homelessness who are admitted to the hospital will be randomised to receive support from a Homeless Outreach Counsellor for 90 days after hospital discharge or to usual care. The primary outcome is follow-up with a primary care provider (physician or nurse practitioner) within 14 days of hospital discharge. Secondary outcomes include postdischarge mortality or readmission, number of days in hospital, number of emergency department visits, self-reported care transition quality, and difficulties meeting subsistence needs. Quantitative outcomes are being collected over a 180-day period through linked patient-reported and administrative health data. A parallel mixed-methods process evaluation will be conducted to explore intervention context, implementation and mechanisms of impact.Ethics and disseminationEthics approval was obtained from the Unity Health Toronto Research Ethics Board. Participants will be required to provide written informed consent. Results of the main trial and process evaluation will be reported in peer-reviewed journals and shared with hospital leadership, community partners and policy makers.Trial registration numberNCT04961762.

Project description:IntroductionIn primary care, the prevalence of neck pain has increased substantially. Evidence regarding treatment of chronic neck pain (CNP) is scarce, and its effectiveness is not entirely proven in different stages of chronicity, nor for different types of cervical disorders. The goal of this study is to evaluate the effectiveness of a complex intervention (COGMO intervention) compared with usual practice in primary care physiotherapy to improve neck pain intensity, severity and disability in patients with CNP.Methods and analysisDesign: a pragmatic cluster-randomised clinical trial design with a 12-month follow-up.Settingprimary care.Participantsphysiotherapists as randomisation unit, and patients as analysis unit.Inclusion criteriaindividuals aged 18 to 65 years suffering from moderate to severe CNP. Sample size expected: 142 patients. Recruitment: patients referred from primary care physicians to physiotherapy.Interventionpain neuroscience education (PNE), motivational interviewing (MI) and cognition targeted exercise therapy (CTE) compared with the standard treatment in primary care.Outcomesthe main variable is reduction in pain intensity; secondary variables include pain severity, conditioned pain modulation, temporal summation, neck disability, fear/avoidance behaviour, kinesiophobia, catastrophising, therapeutic alliance and quality of life. Sociodemographic information and adherence to the intervention will be recorded.Data collectionbaseline, and follow-up at 3, 6 and 12 months.Analysisit will follow intention-to-treat principles, and difference in percentage of subjects achieving success on the primary endpoint at 12 months. A model with multilevel analysis will be adjusted through logistic regression (being the dependent variable pain intensity, and the independent, the intervention).Ethics and disseminationEthical approval has been awarded by the Regional Ethics Committee of Madrid (code: COGMO-AP) and the primary health care central commission of research (code: 20210011). The results of the study will be disseminated through international peer-reviewed journals, international conferences, press and social media.Trial registration numberNCT05785455.

Project description:IntroductionLow back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).Methods and analysisA pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.Ethics and disseminationApproved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberACTRN12619001134112.

Dataset Information

NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

NEUROCANTRIAL: study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain.

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