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临床试验/NCT03556423
NCT03556423已完成不适用

Pain in Individuals With Knee Osteoarthritis : Beyond the Joint and the Musculoskeletal System

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Change from baseline - Integrity of the corticospinal system

研究概览

简要总结

Introduction: Total knee arthroplasty (TKA) is an effective intervention to relieve people with osteoarthritis (OA). Nevertheless, 15 to 30% of patients continue to experience severe pain following surgery. Recent data suggest that central nervous system (CNS) changes may play a role in OA pain and possibly explain why some patients have poorer clinical outcomes following TKA. Objectives: Our main objectives are to explore the relationship between OA pain and (1) the integrity of corticospinal system, (2) the efficacy of descending pain inhibition circuits. Methods: Fifty-two patients waiting for TKA will be recruited. The integrity of the corticospinal projections will be measured using transcranial magnetic stimulation (recruitment curve of the affected quadriceps femoris muscle) and the descending pain inhibition circuits (bulbospinal projections) will be assessed by a counter-irritation paradigm (i.e., conditioned pain modulation with immersion of the arm in painfully cold water). Diffuse tension imaging (DTI) will also be used to quantify the strength of these corticospinal and bulbospinal projections. Clinical outcomes will be evaluated before and after arthroplasty with a series of validated questionnaires such as the WOMAC Scale, the McGill Pain Questionnaire and the Brief Pain Inventory. These different neurophysiological and clinical measures will be taken before surgery, 6 months after surgery and 1 year post-surgery. Anticipated results: The investigators expect a moderate association between pain and the strength of the corticospinal and bulbospinal projections. Moreover, it is expected that there will be a moderate association between the strength of the corticospinal/bulbospinal projections and the clinical evolution of patients.

详细描述

See outcome measures

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
50 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being an adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
  • Refrain from consuming cigarettes and caffeine 2 hours and 6 hours before testing, respectively
  • Refrain from taking short-acting analgesics (e.g., acetaminophen) 6 hours before testing

排除标准

  • Having difficulty understanding french language
  • Having a diagnosis of neurological disorder or diagnosis of chronic pain (other knee OA)
  • Having metal implants in the skull
  • Having pacemaker or neurostimulator
  • Being pregnant
  • Being epileptic

结局指标

主要结局

Change from baseline - Integrity of the corticospinal system

时间窗: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by transcranial magnetic stimulation (TMS)

Change from baseline - Descending pain inhibition circuits

时间窗: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by a counter-irritation paradigm (conditioned pain modulation using a thermode and a bath of circulating cold water)

Change from baseline - Pain intensity

时间窗: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by a visual analogue scale (VAS). The VAS is a straight horizontal line of fixed length, usually 10 cm. The ends are defined as the extreme limits of the parameter to be measured; 0 = "no pain", 10 = "the worst imaginable pain". Using a ruler, the score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.

Change from baseline - Pain, stiffness and physical function

时间窗: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

次要结局

  • Kinesiophobia(Before surgery, 6 months and 1 year post-surgery)
  • Anxiety(Before surgery, 6 months and 1 year post-surgery)
  • Pain catastrophizing(Before surgery, 6 months and 1 year post-surgery)
  • Qualitative aspect of pain(Before surgery, 6 months and 1 year post-surgery)
  • Impact of pain on physical function and quality of life(Before surgery, 6 months and 1 year post-surgery)
  • Functional autonomy, social autonomy(Before surgery, 6 months and 1 year post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillaume Léonard

Professor

Université de Sherbrooke

研究点 (2)

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