Clinical trial NCT06052384: Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists
Official title: Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Primary outcomes:
measure: The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
Secondary outcomes:
measure: The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The score of the French version of the Brief Pain Inventory (BPI).
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The score of the French version of the McGill pain questionnaire (MPQ)
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The score of Hospital anxiety and depression scale (HADS)
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The score of the French version of Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The score of the Epworth Sleepiness scale
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The score of the Patient Global Impression of Change (PGIC) scale
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The drug consumption, particularly analgesics, antidepressants, benzodiazepines and related hypnotics
timeFrame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
measure: The cost-utility ratio for the medico-economic impact of the care pathway
timeFrame: Change from baseline (Day 0) at Month 6
measure: The score of the International Restless legs syndrome (IRLS) questionnaire
timeFrame: At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
measure: For the experimental group, the average apnea-hypopnea index (AHI)
timeFrame: at start of ventilation (continuous positive airway pressure), then for periods Month 3-Month 6 and Month 6-Month 12
measure: For the experimental group, the score of the insomnia severity index (ISI)
timeFrame: At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
Study officials:
References: