An observational study in Chronic Low Back Pain, sponsored by Poitiers University Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by Poitiers University Hospital · Observational
Seventy-eight percent of the population declares being concerned by pain, directly or indirectly. Chronic pain, defined as pain that has lasted for more than three months, affects more than one third of the French population. The national survey of the French Society for the Study and Treatment of Pain (SFETD), conducted in 2009, reveals that the most widespread chronic pain is low back pain (20%).
Pain not only affects the body, but also destroys the person who endures it. A comparative study by Attal et al. carried out on a sample of 1,591 chronic pain sufferers and 1,237 non pain sufferers shows a major impact of pain on the individual's quality of life (SF12), sleep (MOS sleep) and anxiety and depression (HADS).
The 2009 report of the French National Authority for Health (HAS) shows that chronic pain generates a significant societal cost. Low back pain is the leading cause of activity limitation in people aged 45 to 65, and the third leading cause of chronic disability. It is the leading cause of disability in people under 45 years of age, and the leading cause of work stoppage and occupational disease.
The reference tool for assessing pain is currently the Visual Analogue Scale (VAS). However, several factors considerably limit the relevance of an exclusive use of this tool:
To overcome the limitations of the VAS, the PRISMATICS team has developed a triply patented computerized tactile mapping system.
It allows to take into account the objective parameters of pain intensity and surface in a given individual, in a reliable, reproducible and quantitative way.
The Neuro-Mapping Tool: its purpose is to evaluate very precisely the extent of the patient's painful surface at a given moment.
. This prospective study aims to optimize the care pathway and to introduce rationalization and objectivity in the evaluation of therapies proposed to patients.
This study will help us to test the following hypotheses:
Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients suffering from chronic low back pain, consulting at the pain center of Poitiers and/or in consultation in the department of Neurosurgery of Spine - Neurostimulation - Handicap will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pain Visual Analogic Scale (0 to 10 points)
Pain scale: 0 (minimum pain) to 10 (maximum pain)
Time frame: 12 months
Oswestry Disability Index (0 to 100%)
The questionnaire consists in 10 items ranging from 0 to 5 where 0 indicates high ability to perform the task associated with the item and 5 indicates the inability to perform the task. Items included pain intensity, degree of disability for personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life and travelling.
Time frame: 12 months
Quality of Life (0 to 1)
The questionnaire comprises five items including pain intensity, mobility, self-care, daily activities and psychological state (Anxiety or depression). Each item consists in a 5 level Likert scale ranging from "I have no problem" to "I am unable to". The maximum score of 1 indicates the best possible quality of life.
Time frame: 12 months
Anxiety and Depression Scale (0 to 24)
The questionnaire consists in 14 items each comprising 4 levels and either representing a symptom of anxiety or depression. The total score ranges from 0 to 24 for each category (depression or anxiety). A score of 11 or above indicates a definite symptomatology.
Time frame: 12 months
Pain Mapping (cm²)
The patient had to draw on the touch screen interface his/her pain in a pre-determined body (in relation with his/her BMI). Before drawing the painful area, the patient chose the red/orange/dark or light blue colour, depending on the pain intensity.
Time frame: 12 months
Patient Global Impression of change (0 to 7 "strong impression of change")
Although widely used in chronic pain clinical trials, the validity of PGIC has not been formally evaluated. PGIC is a 7-point scale, assessing patient's perceived improvement.
Time frame: 12 months
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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