Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Location status: Recruiting
NCT Number: NCT06052384
DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Le Puy-en-Velay, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard pain management combined with sleep disorder management at M6, and M12
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
This questionnaire assesses the patient's pain experience and the impact of pain on the patient's daily behavior. It evaluates seven general aspects of the patient's life, divided into fifteen items: activity, mood, walking ability, work, relationships, sleep and enjoyment of life. The score ranges from 0 to 10 with 0 = no pain and 10= worst pain.
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
This questionnaire assesses the sensory and emotional dimensions of the patient's pain. It is composed of twenty-two items.
Each item is scored from 0 to 10, with 0 corresponding to "no pain", 5 to "moderate pain" and 10 to "extremely severe pain".
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
This questionnaire can be used to detect anxiety or depression. For each component (seven items for the "anxiety" component and seven items for the "depression" component), the score obtained is analyzed. A score less than or equal to 7 indicates no symptomatology, a score between 8 and 10 indicates doubtful symptomatology, and a score greater than or equal to 11 indicates definite symptomatology.
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
This is a generic nineteen-item questionnaire for measuring sleep problems. A PSQI score less than or equal to 5 designates "good sleepers", while a score strictly greater than 5 designates "poor sleepers".
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
This scale is made up of 8 questions and the final score obtained ranges from 0 to 24: [0-6] = Absence of drowsiness; [7-9] = contentious score which may indicate a pathological condition; [10-24] = Risk of pathological drowsiness.
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
This scale is used to assess the evolution of the patient's state of health in terms of activity limitation, symptoms, emotions and quality of life. This scale ranges from 1 "greatly improved" to 7 "greatly worsened", for which the patient is asked to choose the phrase that best represents the changes in his or her overall health.
Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
INN , dosage and duration
Time frame: Change from baseline (Day 0) at Month 6
The costs avoided in terms of drug consumption, as well as changes in patients' quality of life at different stages.
Time frame: At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
The latter assesses the severity of RLS according to four levels: for a score between 0 and 10, the disorder is mild; between 11 and 20, moderate; between 21 and 30, severe; between 31 and 40, very severe.
Time frame: at start of ventilation (continuous positive airway pressure), then for periods Month 3-Month 6 and Month 6-Month 12
It represents the average frequency of apneas and hypopneas per hour of sleep. There are three levels of apnea and hypopnea severity. The mild degree corresponds to respiratory incidents of between 5 and 15 per hour, the moderate degree corresponds to respiratory incidents between 15 and 30 per hour, and the severe degree indicates more than 30 respiratory events per hour.
Time frame: At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
This validated self-questionnaire consists of 7 questions designed to assess the nature of insomnia, sleep satisfaction, day-to-day functioning and anxiety about sleep disorders. Each of the 7 items is evaluated on a 5-point Likert scale (from 0 to 4). The total score is obtained by adding together the scores of the 7 items . The total score ranges from 0 to 28: [0-7] = No insomnia; [8- 14] = Subclinical insomnia (mild); [15-21] = Clinical insomnia (moderate); [22-28] = Clinical insomnia (severe).
Centre Hospitalier Emile Roux
Other
Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil
Acronym: DOLOREPIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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