Why clinical trials in disc regeneration strive to achieve completion: Insights from publication status and funding sources.

Background: Chronic discogenic low back pain (LBP) poses a significant global burden, yet effective therapeutic interventions directly targeting the underlying degenerative process remain elusive. After demonstrating promising results in preclinical studies, intradiscal injection of cell-based treatments has been increasingly investigated in the clinical setting. However, most clinical trials failed to reach publication, with the few available reports showing only minor improvements. The aim of this study was to analyze the prospective clinical trials registered on ClinicalTrials.gov investigating cell therapies for LBP, with a specific emphasis on identifying critical obstacles hindering study completion, including trial design and funding sources. Methods: A systematic search of prospective clinical trials investigating cell-based treatments for chronic LBP due to intervertebral disc degeneration was performed on ClinicalTrials.gov. Extracted data encompassed study design, recruitment, experimental treatment modalities, investigated outcomes, current status, completion date, publication status, and funding sources. Fisher's exact test assessed associations between categorical variables, while a multiple logistic regression model aimed to identify factors potentially linked to the publication status of the studies. Results: Our search identified 26 clinical trials. Among these, only 7 (26.9%) were published, and none of the other studies marked as completed reported any results on ClinicalTrials.gov. Fifty percent of included trials were funded by universities, whereas the rest was sponsored by industry (38.5%) or private institutions (11.5%). Experimental treatments primarily involved cell-based or cell-derived products of varying sources and concentrations. Products containing carriers, such as hyaluronic acid or fibrin, were more frequently funded by industry and private organizations (p = 0.0112). No significant differences emerged when comparing published and nonpublished studies based on funding, as well as between publication status and other variables. Conclusion: Most clinical trials exploring cell-based disc regenerative therapies for chronic LBP have never reached completion, with only a small fraction reporting preliminary data in publications.

Importance of an Integrated Assessment of Functional Disability and Work Ability in Workers Affected by Low Back Pain.

Background: This study examines the relationship between functional disability and work ability in workers affected by low back pain (LBP) through an analysis of correlations between the Oswestry Disability Index (ODI) and Work Ability Index (WAI). The role of personal and work factors on functional disability/work ability levels has also been studied. LBP is the most common musculoskeletal problem and a major disabling health problem worldwide. Its etiology is multifactorial. Multidisciplinary approaches may help reduce the burden of pain and disability and improve job continuity and reintegration at work. Methods: A cohort of 264 patients affected by LBP from an Italian outpatient clinic were included in a clinical diagnostic/therapeutic trial aiming at rehabilitation and return to work through an integrated investigation protocol. Data were collected during the first medical examination using anamnestic and clinical tools. The final sample is composed of 252 patients, 57.1% man, 44.0 % blue collars, 46.4% with the high school degree, 45.6% married. Results: WAI and ODI reported a negative and fair correlation (r = -0.454; p = .000). Workers with acute LBP symptoms have a higher probability of severe disability than those with chronic LBP symptoms. White collars without depressive symptoms reported higher work ability - even in chronic disability conditions-than those with depressive symptoms. Conclusion: The study found that ODI and WAI have a convergent validity and this suggests that the two tools measure capture distinctive aspects of disability related to personal, environmental, and occupational characteristics. The most important and modifiable prognostic factors found for ODI and WAI were depressive symptoms, workday absence, and intensity of back pain. The study also found a mild association between age and ODI. The study's findings highlight the importance of using a multidisciplinary approach to manage and prevent disability due to LBP.

Nurses experience with body care among palliative care patients: a phenomenological study.

BACKGROUND: Palliative care is defined as active and global care that provides holistic care integrating the body, mind and spirit of the dying person. A person's health deteriorates at the end of life and nurses facilitate patients to manage their personal body care. Knowing and considering the impact of disease on individuals' lives, how they adapt to cope with it, and the meaning they give to it, can help nurses. This is because of the embodiment concept of living in and through our bodies. The aim of the study is to explore palliative care patients' experiences with nurses during body care. METHODS: A descriptive phenomenological approach based on Husserl's philosophical perspective was used. A purposive sample of eight palliative care patients were enrolled in the study. Semi-structured interviews were conducted between November 2018 and January 2019, in an Italian hospice. The interviews were about patients' feelings during nursing body care. The transcripts were analysed using Giorgi's phenomenological method. Several strategies were used to ensure the study's reliability. RESULTS: The qualitative analysis revealed six categories that converged in three themes: 1) body care requires a specific competence; 2) patients experience difficulties during care by nurses; 3) compassionate care relationships help patients to find wellbeing and balance. CONCLUSIONS: People at the end of life find the deterioration of their body distressing and a reminder that they are about to die. These considerations give us an understanding of patient embodiment and the significance of a patient's lived experiences at the end of their life. This phenomenon in nursing should be explored further in future research, to help inform more targeted care strategies.

The Effect of Transitioning to Remote Working in Patients Affected by Chronic Low Back Pain: A Cross-Sectional Study.

OBJECTIVE: To assess the effect of transitioning to remote working during the coronavirus disease 2019 pandemic in a population of adults affected by chronic low back pain (cLBP). METHODS: An online questionnaire was sent by email to teleworkers affected by cLBP. Demographic data, remote working features and tasks, and LBP burden were analyzed. The psychological burden of remote working was evaluated with the World Health Organization Five Well-Being Index and the Patient Health Questionnaire-2. LBP severity was evaluated using a visual analogue scale. LBP-related disability was assessed using the Oswestry Disability Index. The effect of LBP on working capacity was examined with the Occupational Role Questionnaire. Independent risk factors related to LBP worsening were identified using a multivariate logistic regression model. RESULTS: During remote working, LBP severity was significantly higher compared to previous in-person working (p < 0.0001), as well as average weekly work hours (p < 0.001). Furthermore, the risk of LBP worsening was associated with higher depression scores (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.00-1.91; p = 0.048), increased stress levels (OR: 3.00, 95% CI: 1.04-8.65; p = 0.042), and being divorced (OR: 4.28, 95% CI: 1.27-14.47; p = 0.019). Conversely, living with others (OR: 0.24, 95% CI: 0.07-0.81; p = 0.021), and reporting unchanged stress levels (OR: 0.22, 95% CI: 0.08-0.65; p = 0.006) were associated with a lower risk of LBP worsening. CONCLUSION: Our findings highlight key factors to consider for improving remote workers' physical and mental wellbeing and decrease their LBP burden.

Effectiveness of immersive virtual reality on anxiety, fatigue and pain in patients with cancer undergoing chemotherapy: A systematic review and meta-analysis.

PURPOSE: This Systematic review and meta-analysis aimed to assess the effectiveness of Virtual Reality on anxiety, fatigue and pain in patients with cancer during chemotherapy and provide evidence for decision-making in clinical practice. METHODS: A systematic literature search was performed in the databases PubMed, Web of Science, Scopus, Cumulative Index of Nursing and Allied Health Literature and the Cochrane Library. Risk of Bias was used to assess the quality of individual studies, and Grading of Recommendations Assessment, Development and Evaluation was used to assess confidence for each individual outcome. A random-effects model was used to examine the overall effect. RESULTS: Four randomized controlled trials and four crossover studies were included, with an overall sample of 459 patients. Results showed that Virtual Reality compared with standard care had a significant reduction of anxiety only (MD = -6.57, 95% CI: -11.59 to -1.54, p = 0.01) but with considerable heterogeneity (I2 = 92%), while Virtual Reality was not significantly different from integrative interventions. The trials included showed small sample sizes, lack of statistical power, low methodological quality, high heterogeneity, and different Virtual Reality technology types, lengths and frequencies. CONCLUSION: The quality of evidence is very low and the strength of recommendation is weak. Further research has large potential for reducing uncertainty about the effects of Virtual Reality in patients with cancer receiving chemotherapy. This study was registered with PROSPERO as CRD42020223375.

Can Smart Home Technologies Help Older Adults Manage Their Chronic Condition? A Systematic Literature Review.

The management of chronic diseases requires personalized healthcare that allows older adults to manage their diseases at home. This systematic review aimed to describe the smart home technologies used in the management of chronic diseases in older people. A systematic literature review was conducted on four databases and was reported following the PRISMA statement. Nineteen articles were included. The intervention technologies were classified into three groups: smart home, characterized by environmental sensors detecting motion, contact, light, temperature, and humidity; external memory aids, characterized by a partnership between mobile apps and smart home-based activity learning; and hybrid technology, with the integration of multiple technologies, such as devices installed at patients' homes and telemedicine. The health outcomes evaluated are vital signs, medication management, ADL-IADL, mobility, falls, and quality of life. Smart homes show great potential in the management of chronic diseases by favouring the control of exacerbations and increasing patients' safety by providing support in disease management, including support for cognitively impaired older people. The use of smart homes in the community could bring numerous benefits in terms of continuity of care, allowing the constant monitoring of older people by local and hospital health services.

COVID-19 Pandemic Increases the Impact of Low Back Pain: A Systematic Review and Metanalysis.

In March 2019, the World Health Organization (WHO) recognized the COVID-19 pandemic as a global issue. To reduce the spread of this disease, health safety pathways were implemented worldwide. These extraordinary measures changed people's lifestyles, e.g., by being forced to isolate, and in many cases, to work remotely from home. Low back pain (LBP), the most common cause of disability worldwide, is often a symptom of COVID-19. Moreover, it is often associated with different lifestyle features (type of job, physical activity, body weight). Therefore, the purpose of this systematic review and meta-analysis was to estimate the effect of the COVID-19 lockdown on LBP intensity and prevalence compared with LBP rates before the pandemic. A systematic search was performed on Scopus, PubMed, and Cochrane Central. Overall, eight studies with 2365 patients were included in the analysis. We used the Joanna Briggs Institute (JBI) critical appraisal tool to evaluate the risk of bias: six studies (75%) were at moderate risk of bias and two studies (25%) were at low risk of bias. These studies showed an increase in both the prevalence and intensity of LBP during the COVID-19 lockdown.

Psychological Approaches for the Integrative Care of Chronic Low Back Pain: A Systematic Review and Metanalysis.

Chronic low back pain (CLBP) is the most common cause of disability worldwide, affecting about 12% to 30% of the adult population. Psychological factors play an important role in the experience of pain, and may be predictive of pain persistence, disability, and long-term sick leave. The aim of this meta-analysis was to identify and to describe the most common psychological approaches used to treat patients who suffer from CLBP. A systematic search was performed on PubMed/MEDLINE and Cochrane Central. Overall, 16 studies with a total of 1058 patients were included in the analysis. Our results suggest that cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) interventions are both associated with an improvement in terms of pain intensity and quality of life when singularly compared to usual care. Disability also improved in both groups when compared to usual care. Significant differences in fear-avoidance beliefs were noted in the CBT group compared to usual care. Therefore, psychological factors are related to and influence CLBP. It is crucial to develop curative approaches that take these variables into account. Our findings suggest that CBT and MBSR modify pain-related outcomes and that they could be implemented in clinical practice.