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临床试验/NCT05713604
NCT05713604招募中不适用

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

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
2
主要终点
The scores of the various components of the 'MecPain' questionnaire

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The scores of the various components of the 'MecPain' questionnaire

时间窗: Six months

A score will be assigned based on the answers to each of the 12 questions of the 'MecPain' questionnaire

次要结局

  • The scores of the'DN4' and 'PainDETECT' questionnaires(Six months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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