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

Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil

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 Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Standard pain management combined with sleep disorder management

• Study Type: Interventional
• Enrollment (Estimated): 664
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Puy-en-Velay, France
    • Recruiting
    • Centre Hospitalier Emile ROUX
    • Contact: Sophie LENGAGNE; Phone Number: 0471043526; Email: sophie.lengagne@ch-lepuy.fr
    • Principal Investigator: Christèle PEREZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reinforced sleep program; standard pain management + sleep disorders management	Other: Standard pain management combined with sleep disorder management; Standard pain management combined with sleep disorder management at M3, M6, and M12
No Intervention: Standard care; Control group: standard pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Physical Composite Score (PCS) 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)
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.	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)	This questionnaire assesses the sensory and emotional dimensions of the patient's pain. It is composed of sixteen items, the first eight of which characterize pain from a sensory point of view, and the following eight from an affective point of view. Each item is scored from 0 to 4, with 0 corresponding to "no pain", 1 to "mild pain", 2 to "moderate pain", 3 to "severe pain" and 4 to "extremely severe pain".	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)	This questionnaire can be used to detect anxiety or depression. For each component (seven items for the "anxiety" component and seven items for the "depression" component), the score obtained is analyzed. A score less than or equal to 7 indicates no symptomatology, a score between 8 and 10 indicates doubtful symptomatology, and a score greater than or equal to 11 indicates definite symptomatology.	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)	This is a generic nineteen-item questionnaire for measuring sleep problems. A PSQI score less than or equal to 5 designates "good sleepers", while a score strictly greater than 5 designates "poor sleepers".	Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
The score of the Epworth Sleepiness scale	This scale is made up of 8 questions and the final score obtained ranges from 0 to 24: [0-6] = Absence of drowsiness; [7-9] = contentious score which may indicate a pathological condition; [10-24] = Risk of pathological drowsiness.	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	This scale is used to assess the evolution of the patient's state of health in terms of activity limitation, symptoms, emotions and quality of life. This scale ranges from 1 "greatly improved" to 7 "greatly worsened", for which the patient is asked to choose the phrase that best represents the changes in his or her overall health.	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	INN , dosage and duration	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	The costs avoided in terms of drug consumption, as well as changes in patients' quality of life at different stages.	Change from baseline (Day 0) at Month 6
The score of the International Restless legs syndrome (IRLS) questionnaire	The latter assesses the severity of RLS according to four levels: for a score between 0 and 10, the disorder is mild; between 11 and 20, moderate; between 21 and 30, severe; between 31 and 40, very severe.	At the 1st sleep consultation (Month 1) then at Month 6 and Month 12
For the experimental group, the average apnea-hypopnea index (AHI)	It represents the average frequency of apneas and hypopneas per hour of sleep. There are three levels of apnea and hypopnea severity. The mild degree corresponds to respiratory incidents of between 5 and 15 per hour, the moderate degree corresponds to respiratory incidents between 15 and 30 per hour, and the severe degree indicates more than 30 respiratory events per hour.	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)	This validated self-questionnaire consists of 7 questions designed to assess the nature of insomnia, sleep satisfaction, day-to-day functioning and anxiety about sleep disorders. Each of the 7 items is evaluated on a 5-point Likert scale (from 0 to 4). The total score is obtained by adding together the scores of the 7 items . The total score ranges from 0 to 28: [0-7] = No insomnia; [8- 14] = Subclinical insomnia (mild); [15-21] = Clinical insomnia (moderate); [22-28] = Clinical insomnia (severe).	At the 1st sleep consultation (Month 1) then at Month 6 and Month 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Emile Roux

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: RIPH2_PEREZ_DOLOREPIT; 2022-A00919-34 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No