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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05713604
Other study ID # Grenoble University Hospital
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2023
Est. completion date December 1, 2023

Study information

Verified date January 2023
Source University Hospital, Grenoble
Contact Hasan HODAJ, MD - PhD
Phone 0476765213
Email hhodaj@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 1, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU de GRENOBLE ALPES Grenoble Alpes
France Henri Mondor Paris

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The scores of the various components of the 'MecPain' questionnaire A score will be assigned based on the answers to each of the 12 questions of the 'MecPain' questionnaire Six months
Secondary The scores of the'DN4' and 'PainDETECT' questionnaires Scores of the'DN4" ranging from 0 to 10 and scores 'PainDETECT' ranging from 0 to 38 Six months
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