Status:
RECRUITING
Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
Lead Sponsor:
Centre Hospitalier Emile Roux
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
Inclusion
- First consultation at the pain management center
- Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain must have several of the following characteristics:
- 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;
- Important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain.
- Patients with chronic primary pain (according to the typology defined by the International Classification of Diseases-11) and classified into one of the 4 following categories:
- Chronic generalized pain
- Complex regional pain syndrome
- Chronic primary headache or orofacial pain
- Chronic primary musculoskeletal pain
- Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the score must be available (for randomization purposes)
- Have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for CBT treatment if insomnia is detected
- Affiliation to a French social security system
- Free informed consent
Exclusion
- 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)
- Patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion)
- Patient follow-up difficult (for geographic motives or other reasons)
- Patient under judicial protection of incapable adults or guardianship
- Refusal to participate in the research
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT06052384
Start Date
December 7 2023
End Date
June 1 2027
Last Update
July 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France