NCT06052384 Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
| NCT ID | NCT06052384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Emile Roux |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 664 participants |
| Start Date | 2023-12-07 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 664 participants in total. It began in 2023-12-07 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria: * 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 Criteria: * 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
Frequently Asked Questions
Who can join the NCT06052384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06052384 currently recruiting?
Yes, NCT06052384 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Hospitalier Emile Roux to inquire about joining.
Where is the NCT06052384 trial being conducted?
This trial is being conducted at Le Puy-en-Velay, France.
Who is sponsoring the NCT06052384 clinical trial?
NCT06052384 is sponsored by Centre Hospitalier Emile Roux. The trial plans to enroll 664 participants.
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