Optimization of the Care Pathway for Patients With Chronic Pain: Assessing the Value of Integrating Sleep Specialists

Centre Hospitalier Emile Roux664 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

664

Conditions

Chronic Pain

Interventions

Standard pain management combined with sleep disorder managementOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France

RECRUITING

Outcomes

Primary Outcomes

The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire

It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.

Time frame: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)

Secondary Outcomes

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).

This questionnaire assesses the patient's pain experience and the impact of pain on the patient's daily behavior. It evaluates seven general aspects of the patient's life, divided into fifteen items: activity, mood, walking ability, work, relationships, sleep and enjoyment of life. The score ranges from 0 to 10 with 0 = no pain and 10= worst pain.

Data from ClinicalTrials.gov

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