Clinical trial NCT05713604: "MecPain", a New Questionnaire to Assess Chronic Pain Mechanisms.
Official title: Validation of a New Clinical Questionnaire for the Evaluation of the Pathophysiological Mechanisms of Chronic Pain "MecPain".
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Neuropathic pain
Nociplastic pain
Nociceptive pain
Chronic pain mechanisms
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain for more than 6 months.

Brief summary: Validation of a new clinical questionnaire, called 'MecPain', including 12 questions, aimed at better defining the pathophysiological mechanisms of a chronic pain condition. This questionnaire includes 8 components/sub-components, reflecting various aspects of the 3 main mechanisms of chronic pain: nociceptive, neuropathic, nociplastic. A series of 240 patients with well-characterized chronic pain syndrome (for more than 6 months) of the nociceptive, neuropathic or nociplastic type will be recruited (80 patients per type of pain). The patients will be interviewed by a pain specialist to complete the 12 questions of the questionnaire during a routine visit in a Pain Center (CHU Grenobles Alpes, Grenoble, France or CHU Henri Mondor, Creteil, France). The scoring obtained with the 'MecPain' questionnaire will be compared to the presence of neuropathic pain assessed by two previously validated questionnaires, the 'DN4' and the 'PainDETECT' questionnaires. The expected outcome is a validation of the 'MecPain' questionnaire to provide a better understanding of the pathophysiological mechanisms relating to the presence of a chronic pain syndrome in a given patient.

Detailed description: The main objective of this study is to specify the physiopathological mechanisms of a chronic pain syndrome according to 5 main components (+ 3 "sensory" sub-components) reflecting various aspects of the 3 main mechanisms of chronic pain: nociceptive, neuropathic, nociplastic.

A score will be assigned based on the answers to each of the 12 questions of the 'MecPain' questionnaire for each of the 8 components/sub-components mentioned above.

240 chronic pain patients will be included (in two centers), according to 3 categories: 80 patients with nociceptive pain (mechanical or inflammatory joint or spinal pain), 80 patients with neuropathic pain (painful peripheral neuropathy, neuralgia or radiculalgia, pain related with spinal cord or brain injury), and 80 patients with nociplastic pain (fibromyalgia, glossodynia, temporomandibular joint pain, irritable bowel syndrome, painful bladder syndrome).

Eligibility criteria: Inclusion Criteria:

* Presence of a chronic pain syndrome (pain for more than 6 months);
* well-characterized pain syndrome of the nociceptive, neuropathic or nociplastic type

Exclusion Criteria:

* Opposition to the use of data obtained in the context of standard clinical follow-up.

Primary outcomes:
measure: The scores of the various components of the 'MecPain' questionnaire
timeFrame: Six months
Secondary outcomes:
measure: The scores of the'DN4' and 'PainDETECT' questionnaires
timeFrame: Six months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de GRENOBLE ALPES
state: Alpes
city: Paris
country: France
facility: Henri Mondor
Study officials:
References: