Improving care for chronic pain patients by including sleep specialists

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study, known as DOLOREPIT, evaluates two different care pathways for managing chronic pain by integrating sleep disorder management into standard pain management practices. It is a multicenter, randomized, controlled, open-label trial that aims to assess the effectiveness of this integrated approach. Patients will be monitored for their pain management outcomes and sleep quality over the course of the study. The goal is to determine if addressing sleep issues can enhance the overall care and quality of life for individuals suffering from chronic pain.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier Emile Roux
  Le Puy-en-Velay, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.