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

NCT06052384 | Recruiting

• 2 other identifiers: RIPH2_PEREZ_DOLOREPIT2022-A00919-34
• Study Type: interventional
• Target: 664
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

• The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire

  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).

  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)

  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)

  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)

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

Study Arms (2)

Reinforced sleep program

EXPERIMENTAL

standard pain management + sleep disorders management

Other: Standard pain management combined with sleep disorder management

Standard care

NO INTERVENTION

Control group: standard pain management

Interventions

Standard pain management combined with sleep disorder management OTHER

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

Reinforced sleep program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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

You may not qualify 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, 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 follow-up difficult (for geographic motives or other reasons)
• Patient under judicial protection of incapable adults or guardianship
• Refusal to participate in the research

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead

Study Sites (1)

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 25, 2023
• Study Start: December 7, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

FR (1)