Chronic Low Back PainPREDIPAINNCT05209854
Evaluation of Therapeutic Management in Chronic Low Back Pain Patients
An observational study of Chronic Low Back Pain, run by Poitiers University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- How many people
- 613 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2023to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Be over 18 years of age at the time the agreement is made.
- Have had low back pain for more than 3 months.
- Have back pain greater than or equal to 2 on the Visual Analog Scale.
- Free patient, without guardianship or tutelage, nor subordination
- No objection from the patient after clear and fair information about the study
Who cannot join
- Have a life expectancy of less than 12 months (assessed by the physician) at the time of inclusion.
- Persons benefiting from reinforced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, pregnant or breast-feeding women and finally patients in emergency situations
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Poitiers University Hospital
Poitiers, Vienne, 86000
Philippe RIGOARD, MD, PhD, +33549444444, philippe.rigoard@chu-poitiers.fr
Philippe RIGOARD, MD, PhD
About this study
Official title: Evaluation of the Effectiveness of Therapeutic Management in the Care of Chronic Low Back Pain Patients: a Single-center Observational Study.
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).
Read more
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:
- For the patient: the intensity of pain is objectively influenced by many parameters such as the time of day, stress, position, duration of evolution, mechanical or "neuropathic" character, paroxysms, etc. These are all elements that objectively disrupt the evaluation performed by the VAS. When the subjective and emotional dimension is included in these elements, the cloudiness of "true" perception of such a sensation increases even more.
- Difficulties of evaluation for the carer: carers are therefore confronted with a lack of relevance of objective pain evaluation tools, and researchers have to deal with data that are often not very reproducible. A fortiori, the second problem arising from this concerns the difficulty of comparing the effectiveness of different therapeutic strategies. The VAS cannot, for example, take into account the pain dominance in the case of multi-site pain, nor the surface area of the pain zone or even less its typology or topology. This information is however essential to determine the choice of the most appropriate therapeutic strategy.
- The difficulties of evaluation for the health care system: in fact, beyond the therapeutic wandering imposed on certain patients on a "micro" scale, it must be considered that this randomness of evaluation has an impact on the entire health care system. When a decision has to be made to reimburse a particular expensive drug or implantable medical device for pain relief, this reflection has to be extended to the "macro" level. This review thus reveals a threefold need for innovation in pain assessment: for the patient, for the caregiver and for the healthcare system.
Read the detailed description
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:
- Sociodemographic, psychological, and physiological factors are associated with patient response to the standard care pathway offered to patients with low back pain.
- The different assessment tools are correlated with their evolution.
- The effect of different therapies varies according to patient characteristics.
- Conditions
- Chronic Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogic Scale (0 to 10 points)
Pain scale: 0 (minimum pain) to 10 (maximum pain)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start2 Mar 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 613 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel ROULAUD, MSc, Study director, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209854
- Sponsor's protocol ID
- PREDIPAIN
- Acronym
- PREDIPAIN
- Status last verified
- May 2023
- First submitted
- 13 Jan 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Therapeutic Management in the Care of Chronic Low Back Pain Patients: a Single-center Observational Study.
- ClinicalTrials.gov ID
- NCT05209854
- Acronym / sponsor ID
- PREDIPAIN / PREDIPAIN
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 613 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- For the patient: the intensity of pain is objectively influenced by many parameters such as the time of day, stress, position, duration of evolution, mechanical or "neuropathic" character, paroxysms, etc. These are all elements that objectively disrupt the evaluation performed by the VAS. When the subjective and emotional dimension is included in these elements, the cloudiness of "true" perception of such a sensation increases even more.
- Difficulties of evaluation for the carer: carers are therefore confronted with a lack of relevance of objective pain evaluation tools, and researchers have to deal with data that are often not very reproducible. A fortiori, the second problem arising from this concerns the difficulty of comparing the effectiveness of different therapeutic strategies. The VAS cannot, for example, take into account the pain dominance in the case of multi-site pain, nor the surface area of the pain zone or even less its typology or topology. This information is however essential to determine the choice of the most appropriate therapeutic strategy.
- The difficulties of evaluation for the health care system: in fact, beyond the therapeutic wandering imposed on certain patients on a "micro" scale, it must be considered that this randomness of evaluation has an impact on the entire health care system. When a decision has to be made to reimburse a particular expensive drug or implantable medical device for pain relief, this reflection has to be extended to the "macro" level. This review thus reveals a threefold need for innovation in pain assessment: for the patient, for the caregiver and for the healthcare system.
Detailed description
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:
- Sociodemographic, psychological, and physiological factors are associated with patient response to the standard care pathway offered to patients with low back pain.
- The different assessment tools are correlated with their evolution.
- The effect of different therapies varies according to patient characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Be over 18 years of age at the time the agreement is made.
- Have had low back pain for more than 3 months.
- Have back pain greater than or equal to 2 on the Visual Analog Scale.
- Free patient, without guardianship or tutelage, nor subordination
- No objection from the patient after clear and fair information about the study
Key exclusion criteria (2 listed)
- Have a life expectancy of less than 12 months (assessed by the physician) at the time of inclusion.
- Persons benefiting from reinforced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, pregnant or breast-feeding women and finally patients in emergency situations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Visual Analogic Scale (0 to 10 points)
Time frame: 12 months
Pain scale: 0 (minimum pain) to 10 (maximum pain)
Oswestry Disability Index (0 to 100%)
Time frame: 12 months
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.
Quality of Life (0 to 1)
Time frame: 12 months
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.
Anxiety and Depression Scale (0 to 24)
Time frame: 12 months
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.
Pain Mapping (cm²)
Time frame: 12 months
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.
Patient Global Impression of change (0 to 7 "strong impression of change")
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel ROULAUD, MSc study director
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe RIGOARD, MD,PhD (+33549444444, philippe.rigoard@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analogic Scale (0 to 10 points) (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.