"MecPain", a New Questionnaire to Assess Chronic Pain Mechanisms.

Chronic Pain Clinical Trial

— MecPain  

Official title:

Validation of a New Clinical Questionnaire for the Evaluation of the Pathophysiological Mechanisms of Chronic Pain "MecPain".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713604
• Other study ID #: Grenoble University Hospital
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Pain

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