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

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Emile Roux

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

First consultation at the pain management center

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;

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard pain management combined with sleep disorder management

    Other intervention

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

Treatment groups

664 Participants
are divided into 2 treatment groups
Group A: Reinforced sleep programExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
2

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.

Time frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
3

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 twenty-two items. Each item is scored from 0 to 10, with 0 corresponding to "no pain", 5 to "moderate pain" and 10 to "extremely severe pain".

Time frame
Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
4

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.

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

Other outcomes

Sponsors and contacts

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