Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug774 | COVID-19 patients Wiki | 1.00 |
| drug2387 | Mindfulness Meditation Wiki | 0.71 |
| drug4614 | non interventional Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001416 | Back Pain NIH | 1.00 |
| D017116 | Low Back Pain NIH | 1.00 |
| D010146 | Pain NIH | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003419 | Low back pain HPO | 1.00 |
| HP:0012531 | Pain HPO | 0.71 |
Navigate: Correlations HPO
There are 2 clinical trials
Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring non-judgmental and accepting attention to present-moment experiences such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping improve health and well-being, and reduce reliance on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early research, including a pilot study by the Principal Investigator, evidence on MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap. With input from patients, family members, and clinicians, the Investigators have designed a study to address this gap and propose a clinical trial that will compare the effectiveness of MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is hypothesized that MM training will lead to a larger reduction in pain intensity, increase in physical function, improvement in quality of life, and decrease in daily opioid dose, as compared to CBT training, with benefits of MM especially notable in adults with worse mood, anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP and less improvement in response to existing therapies. To test these hypotheses, 766 adults with opioid-treated CLBP will be randomly assigned into one of two 8-week treatment groups: MM (383 participants) that will receive the MM training or CBT (383 participants) that will receive the CBT training. Due to the COVID-19 pandemic-related restrictions, the study protocol was modified in October 2020 so that the study can be completed virtually. The effectiveness of MM versus CBT will be assessed over a 12-month period with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, including patients with opioid-treated CLBP, their families and clinicians.
Description: 4 pain severity items from the Brief Pain Inventory
Measure: Pain Intensity Time: Baseline to 12 monthsDescription: 10-item Oswestry Disability Index
Measure: Physical Function Time: Baseline to 12 monthsDescription: 12-item Short Form-12
Measure: Quality of Life Time: Baseline to 12 monthsDescription: Timeline Followback Method (morphine-equivalent dose [mg/day] over the prior 14 days)
Measure: Daily Opioid Dose Time: Baseline to 12 monthsDescription: 14-item Hospital Anxiety and Depression Scale
Measure: Depression Symptom Severity Time: Baseline to 12 monthsDescription: 14-item Hospital Anxiety and Depression Scale
Measure: Anxiety Symptom Severity Time: Baseline to 12 monthsDescription: 17-item Current Opioid Misuse Measure
Measure: Opioid Use Behaviors Time: Baseline to 12 monthsDescription: 8-item Opioid Compliance Checklist
Measure: Opioid Medication Compliance Time: Baseline to 12 monthsThe current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement. While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain. Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect. The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients. This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.
Description: Proportion of subjects having a significant change in their low back pain intensity during confinement, defined by the items "much worse" and "moderately worse", or "much improved" and "moderately improved" respectively.The meaning of this significant change (worsening or improvement) will also be described.
Measure: Impact of confinement on the low back pain intensity Time: at inclusionDescription: Change in low back pain intensity between before and during confinement evaluated by a numerical pain scale rated from 0 to 10 (0 = no pain ; 10 = worst imaginable pain). Confinement conditions (alone or in a group, space, etc.) and the practice of physical and sporting activities during confinement (weekly duration, etc.)
Measure: Correlation between confinement conditions and low back pain intensity Time: at inclusionDescription: Disability measured by the "incapacity" sub-score of the "Core Outcome Measures Index" (COMI) questionnaire
Measure: Correlation between confinement conditions and disability related to low back pain Time: at inclusionDescription: Occurrence of a SARS-CoV-2 infection and its level of severity (confirmed diagnosis, few or no symptoms, symptoms severely limiting daily activities, hospitalization in a conventional service or in intensive care)
Measure: Correlation between infection with the new SARS-CoV-2 coronavirus and change in low back pain intensity Time: at inclusionDescription: Quality of life and levels of anxiety and depression evaluated with the COMI-AD sub-score (modified version of the COMI integrating the state of psychological health);
Measure: Correlation between confinement conditions and quality of life as well as psychological health Time: at inclusionDescription: Use of care, drug consumption and psychoactive substances (tobacco, cannabis, alcohol, anxiolytics) for low back pain
Measure: Impact of confinement on the use of care and the consumption of medication and psychoactive substances for low back pain Time: at inclusionDescription: Modalities of the the ocupational activity continuation (continuation of the activity, evolution of the working time, telework and modalities of establishment)
Measure: Correlation between working conditions and / or teleworking and low back pain intensity Time: at inclusionDescription: Experience of confinement. Socio-economic characteristics of the participants (age, sex, department, job and socio-professional category).
Measure: Correlation between socio-economic factors and modalities as well as the experience of confinement Time: at inclusionAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports