Dataset Information

EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning.

ABSTRACT: INTRODUCTION:Over 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. METHODS:A 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 DISSEMINATION:The 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 NUMBER:NCT03351075.

SUBMITTER: De Groef A

PROVIDER: S-EPMC6326297 | biostudies-other | 2019 Jan

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning.

De Groef An A Devoogdt Nele N Van der Gucht Elien E Dams Lore L Bernar Koen K Godderis Lode L Morlion Bart B Moloney Niamh N Smeets Ann A Van Wilgen Paul P Meeus Mira M

BMJ open 20190104 1

<h4>Introduction</h4>Over 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 ...[more]

PMID: 30612114

Similar Datasets

Project description:IntroductionPain 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 analysisThis 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 disseminationThis 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 numberNCT05581784.

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:AbstractChronic spinal pain poses complex challenges for health care around the world and is in need of effective interventions. Pain neuroscience education (PNE) is a promising intervention hypothesized to improve pain and disability by changing individuals' beliefs, perceptions, and expectations about pain. Pain neuroscience education has shown promise in small, controlled trials when implemented in tightly controlled situations. Exploration of promising interventions through more pragmatic methodologies is a crucial but understudied step towards improving outcomes in routine clinical care. The purpose was to examine the impact of pragmatic PNE training on clinical outcomes in patients with chronic spine pain. The cluster-randomized clinical trial took place in 45 outpatient physical therapist (PT) clinics. Participants included 108 physical therapists (45 clinics and 16 clusters) and 319 patients. Clusters of PT clinics were randomly assigned to either receive training in PNE or no intervention and continue with usual care (UC). We found no significant differences between groups for our primary outcome at 12 weeks, Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test {mean difference = 1.05 (95% confidence interval [CI]: -0.73 to 2.83), P = 0.25}. The PNE group demonstrated significant greater improvements in pain self-efficacy at 12 and 2 weeks compared with no intervention (mean difference = 3.65 [95% CI: 0.00-7.29], P = 0.049 and = 3.08 [95% CI: 0.07 to -6.09], P = 0.045, respectively). However, a similar percentage of participants in both control (41.1%) and treatment (44.4%) groups reported having received the treatment per fidelity question (yes or no to pain discussed as a perceived threat) at 2 weeks. Pragmatic PT PNE training and delivery failed to produce significant functional changes in patients with chronic spinal pain but did produce significant improvement in pain self-efficacy over UC PT.

Project description:Objectives:The Internet in general, and YouTube in particular, is now one of the most popular sources of health-related information. Pain neuroscience education has become a primary tool for managing persistent pain, based in part on the discovery that information about pain can change pain. Our objective was to examine the availability, characteristics, and content of YouTube videos that address the neuroscience of pain. Methods:We conducted a systematic review of videos on YouTube using the search terms "pain education", "what is pain", and "pain brain" in January 2018. Videos were included if they were in English, were under 10 minutes long, and included information on the neuroscience of pain. Videos were coded for (i) descriptive characteristics (e.g., number of views, duration on YouTube), (ii) source and style, (iii) whether or not they addressed seven pre-determined target concepts of pain neuroscience education (e.g., 'Pain is not an accurate marker of tissue state'), and (iv) how engaging they were. Results:We found 106 unique videos that met the inclusion criteria. The videos ranged from having four views to over five million views (Mdn = 1,163 views), with the three most highly viewed videos accounting for 75% of the total views. Animated videos were much more highly viewed than non-animated videos. Only a small number of videos had been posted by a clearly-identifiable reputable source such as an academic or medical institution (10%), although a number of videos were posted by healthcare professionals and professional medical societies. For a small number of videos (7%), the source was unclear. We found 17 videos that addressed at least one target concept of pain neuroscience science education, only nine of which were considered to be at least somewhat engaging. The target concept 'Pain is a brain output' was considered to be well addressed by the most videos (N = 11), followed by 'Pain is a protector' (N = 10). We found only one video that adequately addressed all seven target concepts of pain neuroscience education. Discussion:YouTube contains a variety of videos that practitioners, patients, and families may view to access pain neuroscience education information. A small portion of these videos addressed one or more target concepts of pain neuroscience education in an engaging manner. It is yet to be determined to what extent patients are able to learn information from these videos, to what extent the videos promote behavior change, and thus to what extent the videos may be useful for clinical practice.

Dataset Information

EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning.

Publications

EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets