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

Overview

DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.

Interventions

• Other Standard pain management combined with sleep disorder management
  Standard pain management combined with sleep disorder management at M6, and M12

Primary outcome measures

• The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]

Secondary outcome measures (12)

• The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The score of the French version of the Brief Pain Inventory (BPI). [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The score of the French version of the McGill pain questionnaire (MPQ) [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The score of Hospital anxiety and depression scale (HADS) [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The score of the French version of Pittsburgh Sleep Quality Index (PSQI) [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The score of the Epworth Sleepiness scale [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The score of the Patient Global Impression of Change (PGIC) scale [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The drug consumption, particularly analgesics, antidepressants, benzodiazepines and related hypnotics [Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)]
• The cost-utility ratio for the medico-economic impact of the care pathway [Time frame: Change from baseline (Day 0) at Month 6]
• The score of the International Restless legs syndrome (IRLS) questionnaire [Time frame: At the 1st sleep consultation (Month 1) then at Month 6 and Month 12]
• For the experimental group, the average apnea-hypopnea index (AHI) [Time frame: at start of ventilation (continuous positive airway pressure), then for periods Month 3-Month 6 and Month 6-Month 12]
• For the experimental group, the score of the insomnia severity index (ISI) [Time frame: At the 1st sleep consultation (Month 1) then at Month 6 and Month 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Centre Hospitalier Emile Roux — Le Puy-en-Velay

Identifiers

NCT: NCT06052384 · RIPH2_PEREZ_DOLOREPIT · 2022-A00919-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗