Clinical trial for Chronic Pain
Official title Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
ClinicalTrials.gov ID: NCT06052384
What this study is testing
- What it's testing
- DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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...
- Patient follow-up difficult (for geographic motives or other reasons)
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Le Puy-en-Velay, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Puy-en-Velay, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.