About this trial
DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First consultation at the pain management center
Persistence or recurrence
Duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months;
Inadequate response to treatment;
Disqualifiers
Patients undergoing cancer treatment or who have completed treatment within the last 2 years
Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease, myositis, Still's disease, lupus erythematosus, etc.)
Immunocompromised patient
Patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator)
Trial design
Parallel
Treatments tested in this trial
Standard pain management combined with sleep disorder management
Other interventionStandard pain management combined with sleep disorder management at M6, and M12
Treatment groups
Trial outcomes
Primary outcomes
The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire
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.
Secondary outcomes
The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire
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.
The score of the French version of the Brief Pain Inventory (BPI).
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.
The score of the French version of the McGill pain questionnaire (MPQ)
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".
The score of Hospital anxiety and depression scale (HADS)
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.
Sponsors and contacts
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