NCT05713604

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 3, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 26, 2023

Last Update Submit

August 1, 2023

Conditions

Keywords

Neuropathic painNociplastic painNociceptive painChronic pain mechanisms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The scores of the'DN4' and 'PainDETECT' questionnaires

    Six months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic pain for more than 6 months.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de GRENOBLE ALPES

Grenoble, Alpes, 38043, France

RECRUITING

Henri Mondor

Paris, France

RECRUITING

MeSH Terms

Conditions

Chronic PainNeuralgiaNociplastic PainNociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Hasan HODAJ, MD - PhD

CONTACT

Jean-Pascal LEFAUCHEUR, MD - PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

February 2, 2023

Primary Completion

July 31, 2023

Study Completion

December 1, 2023

Last Updated

August 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations