Anna Anselmo, Maria Pagano, Francesco Corallo, Irene Cappadona, Davide Cardile, Fabrizio Russo, Alice Laudisio, Giuseppe F Papalia, Angelo Quartarone, Rocco S Calabrò
{"title":"Psychosocial Assessment as a Key Component in an Integrated, Personalized Care Pathway: A Protocol for a Low Back Pain Randomized Controlled Trial.","authors":"Anna Anselmo, Maria Pagano, Francesco Corallo, Irene Cappadona, Davide Cardile, Fabrizio Russo, Alice Laudisio, Giuseppe F Papalia, Angelo Quartarone, Rocco S Calabrò","doi":"10.1007/s40122-025-00741-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Low back pain (LBP) is the primary factor contributing to years lived with disability. In view of the close correlation between the functions of the body, which cannot be examined piecemeal but as an integrated system, a holistic approach allows for a comprehensive assessment of the patient. The main objective of this study is to evaluate the impact of face-to-face or remote rehabilitation treatment on the psychosocial aspects of patients with chronic low back pain (CLBP) examining all possible related dimensions: cognitive function, anxiety and depression, pain perception, treatment adherence, the sexual sphere, family dynamics, social support, dysfunctional communication, quality of life (QoL), while also considering attribution of causes.</p><p><strong>Methods: </strong>This prospective, randomized, controlled trial with blinded outcome assessors evaluates the psychosocial functioning of 86 patients with chronic LBP. Participants divided into two groups to compare tele-rehabilitation with face-to-face rehabilitation with a 1:1 randomization based on a web-based system will all undergo neuropsychological, psychological, and associated clinical condition assessment through standardized tests and ad hoc questionnaires at enrollment (T0), after 1 month (T1), 2 months (T2), and 6 months (T3). The analysis involves descriptive statistics, ANOVA, and correlation tests to evaluate treatment effects and psychosocial outcomes at multiple time points.</p><p><strong>Planned outcomes: </strong>We expect this study to provide a comprehensive, in-depth, and integrated understanding of the patient, shedding light on the challenges they may face in managing chronic LBP (CLBP). Repeated administration of the questionnaires will allow us to monitor the patient over time, assess any changes in their health status, and structure an intervention tailored to their needs. By emphasizing these often neglected areas through a comprehensive, multi-step assessment, it will be possible to quantify and analyze how these risk factors can affect patients' wellbeing and hinder the treatment process and recovery.</p><p><strong>Trial registration: </strong>Registered on Clinicaltrials.gov (ID: NCT06895317).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1155-1168"},"PeriodicalIF":3.3000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085730/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-025-00741-7","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/29 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Low back pain (LBP) is the primary factor contributing to years lived with disability. In view of the close correlation between the functions of the body, which cannot be examined piecemeal but as an integrated system, a holistic approach allows for a comprehensive assessment of the patient. The main objective of this study is to evaluate the impact of face-to-face or remote rehabilitation treatment on the psychosocial aspects of patients with chronic low back pain (CLBP) examining all possible related dimensions: cognitive function, anxiety and depression, pain perception, treatment adherence, the sexual sphere, family dynamics, social support, dysfunctional communication, quality of life (QoL), while also considering attribution of causes.
Methods: This prospective, randomized, controlled trial with blinded outcome assessors evaluates the psychosocial functioning of 86 patients with chronic LBP. Participants divided into two groups to compare tele-rehabilitation with face-to-face rehabilitation with a 1:1 randomization based on a web-based system will all undergo neuropsychological, psychological, and associated clinical condition assessment through standardized tests and ad hoc questionnaires at enrollment (T0), after 1 month (T1), 2 months (T2), and 6 months (T3). The analysis involves descriptive statistics, ANOVA, and correlation tests to evaluate treatment effects and psychosocial outcomes at multiple time points.
Planned outcomes: We expect this study to provide a comprehensive, in-depth, and integrated understanding of the patient, shedding light on the challenges they may face in managing chronic LBP (CLBP). Repeated administration of the questionnaires will allow us to monitor the patient over time, assess any changes in their health status, and structure an intervention tailored to their needs. By emphasizing these often neglected areas through a comprehensive, multi-step assessment, it will be possible to quantify and analyze how these risk factors can affect patients' wellbeing and hinder the treatment process and recovery.
Trial registration: Registered on Clinicaltrials.gov (ID: NCT06895317).
期刊介绍：
Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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